Lilly Diabetes: Pipeline Update
|
|
- Avis Brooks
- 7 years ago
- Views:
Transcription
1 Lilly Diabetes: Pipeline Update June 24, 2013
2 Safe Harbor Provision This presentation contains forward-looking statements that are based on management's current expectations, but actual results may differ materially due to various factors. The company's results may be affected by factors including, but not limited to, the risks and uncertainties in pharmaceutical research and development; competitive developments; regulatory actions; litigation and investigations; business development transactions; economic conditions; and changes in laws and regulations, including health care reform. For additional information about the factors that affect the company s business, please see the company s latest Forms 10-K and 10-Q filed with the Securities and Exchange Commission. The company undertakes no duty to update forward-looking statements. Lilly Diabetes 2
3 Lilly Diabetes: An Overview Enrique Conterno President, Lilly Diabetes
4 Lilly Diabetes Pipeline Empagliflozin* Empagliflozin* Tradjenta Tradjenta Tradjenta Empagliflozin* Tradjenta Dulaglutide* Bydureon** Bydureon** Tradjenta Dulaglutide* Novel Basal Insulin Analog* Orals GLP-1s Byetta** Byetta** Tradjenta Dulaglutide* New Insulin Glargine Product* New Insulin Glargine Product* Basal Insulins Humulin Humulin Humulin Humulin Humulin Humulin Marketed Insulins Humalog Humalog Humalog Humalog Humalog Humalog Delivery Devices Delivery Devices Delivery Devices Delivery Devices Delivery Devices Delivery Devices Delivery Devices The following assets are part of the Lilly-Boehringer Ingelheim collaboration: Tradjenta, Empagliflozin, New Insulin Glargine Product. *The safety and efficacy of the agents under investigation has not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated. **The exenatide transition from Lilly to BMS was completed on March 31 st 2013 Lilly Diabetes 4
5 Empagliflozin Thomas Seck, M.D. Associate Therapeutic Area Head, Medical Affairs, Boehringer Ingelheim *Empagliflozin came from Boehringer Ingelheim s research and is part of the Lilly-Boehringer Ingelheim Alliance. The safety and efficacy of empagliflozin has not been established. There is no guarantee that empagliflozin will receive regulatory approval and become commercially available for the uses being investigated.
6 Empagliflozin Empagliflozin Presentation Agenda Overview: SGLT2 inhibition and Empagliflozin Monotherapy Study (EMPA-REG MONO) Add-on to Metformin Study (EMPA-REG MET) Add-on to Basal Insulin Study (EMPA-REG BASAL) Pooled Analysis of Efficacy and Effects on Blood Pressure and Lipids Pooled Analysis of Genital Infections and Urinary Tract Infections Summary and Next Steps Lilly Diabetes 6 6
7 Empagliflozin Empagliflozin Presentation Agenda Overview: SGLT2 inhibition and Empagliflozin Monotherapy Study (EMPA-REG MONO) Add-on to Metformin Study (EMPA-REG MET) Add-on to Basal Insulin Study (EMPA-REG BASAL) Pooled Analysis of Efficacy and Effects on Blood Pressure and Lipids Pooled Analysis of Genital Infections and Urinary Tract Infections Summary and Next Steps Lilly Diabetes 7 7
8 Empagliflozin Mode of action of SGLT2 inhibitors: Urinary glucose excretion via SGLT2 inhibition 1 Schematic View of the Kidney Renal tubule GLUCOSE Blood stream GLUCOSE SGLT2 INHIBITION Urinary glucose excretion, removal of calories from the body 1. Gerich JE. Diabet Med. 2010;27:
9 Empagliflozin SGLT2 inhibition targets glucose directly, working independently of beta-cell function and insulin resistance Persistent hyperglycaemia High blood glucose levels over a long time 2. Impaired ß-cell function Reduced ability of the pancreas to produce insulin 3. Insulin resistance Cells require more insulin to absorb the same amount of glucose 1. DeFronzo RA. Diabetes. 2009;58: ; 2. Poitout V and Robertson RP. Endocrinology. 2002;143: ; 3. Robertson RP, et al. Diabetes. 2003;52: ; 4. DelFronzo RA. Diabetes Obesity Metab. 2012;14:
10 Empagliflozin Empagliflozin Overview 1-4 Empagliflozin is a potent (IC 50 = 3.1 nm) and selective (> 2500-fold over SGLT1) SGLT2 inhibitor Linear PK, rapidly absorbed Peak levels at 1.5 hours after dosing Half-life: hours Mean total radioactivity (human ADME study) recovered in urine and faeces was 54.4% and 41.2%, respectively, and approximately 28.6% of total radioactivity excreted in urine was unchanged No active metabolite 1. Clinicaltrials.gov 2. Aires I and Calado J. Curr Opin Investig Drugs. 2010;11: Grempler R, et al. ADA 2009; Poster no. 521 P 4. Rosenstock J, et al. ADA 2011; Poster no. 989 P Lilly Diabetes 10 10
11 Empagliflozin Empagliflozin Phase III Development Program 1 STUDY Number of patients Background Therapy Primary Efficacy Timepoint Comparator EMPA-REG BASAL 494 Basal Insulin 18 weeks Placebo EMPA-REG MONO 986 N/A 24 weeks Placebo EMPA-REG MET 706 Metformin 24 weeks Placebo EMPA-REG METSU 767 Metformin + SU 24 weeks Placebo EMPA-REG PIO 499 Pioglitazone (±metformin) 24 weeks Placebo EMPA-REG OUTCOME 7,000 Various N/A Placebo EMPA-REG H2H-SU 1,548 Metformin 104 weeks Glimepiride EMPA-REG RENAL 664 Various 24 weeks Placebo EMPA-REG BP 816 Various 12 weeks Placebo EMPA-REG COMBO JAPAN 1,082 Various 52 weeks Placebo 1. Clinicaltrials.gov = presented today 11
12 Empagliflozin Empagliflozin Phase III Development Program 1 STUDY Number of patients Background Therapy Primary Efficacy Timepoint Comparator EMPA-REG BASAL 494 Basal Insulin 18 weeks Placebo EMPA-REG MONO 986 N/A 24 weeks Placebo EMPA-REG MET 706 Metformin 24 weeks Placebo EMPA-REG METSU 767 Metformin + SU 24 weeks Placebo EMPA-REG PIO 499 Pioglitazone (±metformin) 24 weeks Placebo EMPA-REG OUTCOME 7,000 Various N/A Placebo EMPA-REG H2H-SU 1,548 Metformin 104 weeks Glimepiride EMPA-REG RENAL 664 Various 24 weeks Placebo EMPA-REG BP 816 Various 12 weeks Placebo EMPA-REG COMBO JAPAN 1,082 Various 52 weeks Placebo 1. Clinicaltrials.gov = included in pooled analyses presented today 12
13 Empagliflozin EMPA-REG MONO Empagliflozin Presentation Agenda Overview: SGLT2 inhibition and Empagliflozin Monotherapy Study (EMPA-REG MONO) Add-on to Metformin Study (EMPA-REG MET) Add-on to Basal Insulin Study (EMPA-REG BASAL) Pooled Analysis of Efficacy and Effects on Blood Pressure and Lipids Pooled Analysis of Genital Infections and Urinary Tract Infections Summary and Next Steps Lilly Diabetes 13 13
14 Empagliflozin EMPA-REG MONO Study Design: Phase III Monotherapy, 24 Weeks Placebo (n = 228) Placebo run-in (2 weeks) Second assessment of eligibility Randomization (n = 899) 10 mg empagliflozin QD (n = 224) 25 mg empagliflozin QD (n = 224) Screening (n = 1,616) (first assessment of eligibility) If HbA 1c 7 to 10% If HbA 1c > 10% 100 mg sitagliptin QD (n = 223) Open-label (OL) 25 mg empagliflozin QD (n = 87) Poster 1085-P American Diabetes Association (ADA) 14
15 HbA1c - Change from Baseline at Week 24 Primary Efficacy Endpoint was Met Empagliflozin EMPA-REG MONO 0.2 Placebo (n = 228) 0.08 Empagliflozin 10 mg (n = 224) 25 mg (n = 224) Sitagliptin (n = 223) Comparison with placebo *Confirmatory tests; p< Change in HbA 1c (%) %* -0.85%* -0.73%* -1 Mean baseline: 7.91% 7.87% 7.86% 7.85% FAS (LOCF) adjusted mean (SE) change from baseline in HbA 1c (%). Poster 1085-P American Diabetes Association (ADA) 15
16 Empagliflozin EMPA-REG MONO Body Weight Change from Baseline at Week 24 Statistically Significant Reductions with Empagliflozin vs. Placebo Empagliflozin Comparison with placebo *Confirmatory tests; p< Placebo (n = 228) 10 mg (n = 224) 25 mg (n = 224) Sitagliptin (n = 223) # p=0.036 Change in Body Weight (kg) Mean baseline: 78.2 kg 78.4 kg 77.8 kg 79.3 kg kg* kg* 0.52 kg # FAS (LOCF) adjusted mean (SE) change from baseline in body weight (kg). Poster 1085-P American Diabetes Association (ADA) 16
17 Empagliflozin EMPA-REG MONO Systolic Blood Pressure Change from Baseline at Week 24 Statistically Significant Reductions with Empagliflozin vs. Placebo 2 1 Placebo (n = 228) Empagliflozin 10 mg (n = 224) 25 mg (n = 224) Sitagliptin (n = 223) 0.5 Comparison with placebo *Confirmatory tests; p<0.05 Change in SBP (mmhg) mmhg Mean baseline: mmhg mmhg mmhg -2.6 mmhg* 0.8 mmhg -3.4 mmhg* Placebo-corrected changes in diastolic blood pressure for empagliflozin 10 and 25 mg, -0.5 and -1.4* mmhg, respectively FAS (LOCF) adjusted mean (SE) change from baseline in SBP (mmhg). Poster 1085-P American Diabetes Association (ADA) 17
18 Empagliflozin EMPA-REG MONO Summary of Adverse Events (AEs) N (%) Placebo Empagliflozin 10 mg Empagliflozin 25 mg Sitagliptin OL Empagliflozin 25 mg Number of patients 229 (100.0) 224 (100.0) 223 (100.0) 223 (100.0) 87 (100.0) Patients with any AE 140 (61.1) 123 (54.9) 135 (60.5) 119 (53.4) 56 (64.4) Patients with investigatordefined, drug-related AEs* Patients with AEs leading to discontinuation of trial drug 17 (7.4) 27 (12.1) 39 (17.5) 19 (8.5) 11 (12.6) 8 (3.5) 2 (0.9) 4 (1.8) 5 (2.2) 3 (3.4) Patients with serious AEs 6 (2.6) 8 (3.6) 5 (2.2) 6 (2.7) 3 (3.4) *The 5 most common investigator-defined drug-related AEs were urinary tract infection, hyperglycemia, pollakiuria, pulyuria, and thirst Poster 1085-P American Diabetes Association (ADA) 18
19 Empagliflozin EMPA-REG MET Empagliflozin Presentation Agenda Overview: SGLT2 inhibition and Empagliflozin Monotherapy Study (EMPA-REG MONO) Add-on to Metformin Study (EMPA-REG MET) Add-on to Basal Insulin Study (EMPA-REG BASAL) Pooled Analysis of Efficacy and Effects on Blood Pressure and Lipids Pooled Analysis of Genital Infections and Urinary Tract Infections Summary and Next Steps Lilly Diabetes 19 19
20 Empagliflozin EMPA-REG MET Study Design Phase III Add-on to Metformin with or without Sulfonylurea, 24 Weeks Placebo (n = 207) Metformin background Patients pre-treated with metformin or metformin + SU 2-week placebo run-in period Randomization (n = 637) 10 mg empagliflozin QD (n = 217) 25 mg empagliflozin QD (n = 213) Screening (n = 2287) (first assessment of eligibility) If HbA 1c 7 to 10% If HbA 1c > 10% Metformin background Open-label (OL) empagliflozin 25 mg QD (n = 69) Poster 1092-P American Diabetes Association (ADA) 20
21 HbA1c Change from Baseline at Week 24 Primary Efficacy Endpoint was Met Empagliflozin EMPA-REG MET Empagliflozin Comparison with placebo *Confirmatory tests; p< Placebo (n = 207) 10 mg (n = 217) 25 mg (n = 213) -0.1 Change in HbA 1c (%) % * -0.64% * Mean baseline: 7.90% 7.94% 7.86% FAS (LOCF) adjusted mean (SE) change from baseline in HbA1c (%). Poster 1092-P American Diabetes Association (ADA) 21
22 Empagliflozin EMPA-REG MET Body Weight Change from Baseline at Week 24 Statistically Significant Reductions with Empagliflozin vs. Placebo Empagliflozin Comparison with placebo Placebo (n = 207) 10 mg (n = 217) 25 mg (n = 213) *Confirmatory tests; p< Change in Body Weight (kg) Mean baseline: 79.7 kg 81.6 kg 82.2 kg kg * kg * FAS (LOCF) adjusted mean (SE) change from baseline in body weight (kg). Poster 1092-P American Diabetes Association (ADA) 22
23 Empagliflozin EMPA-REG MET Summary of Adverse Events (AEs) N (%) Placebo Empagliflozin 10 mg Empagliflozin 25 mg OL Empagliflozin 25 mg Treated patients 207 (100.0) 217 (100.0) 213 (100.0) 69 (100.0) Patients with any AE 121 (58.7) 124 (57.1) 106 (49.5) 38 (55.1) Patients with investigator-defined, drug-related AEs* 25 (12.1) 35 (16.1) 27 (12.6) 11 (15.9) Patients with AEs leading to discontinuation 7 (3.4) 2 (0.9) 5 (2.3) 1 (1.4) Patients with serious AEs 7 (3.4) 7 (3.2) 5 (2.3) 1 (1.4) * The 5 most common investigator-defined drug-related AEs were urinary tract infection, hyperglycemia, hypoglycemia, headache, and pollakiuria Poster 1092-P American Diabetes Association (ADA) 23
24 Empagliflozin EMPA-REG BASAL Empagliflozin Presentation Agenda Overview: SGLT2 inhibition and Empagliflozin Monotherapy Study (EMPA-REG MONO) Add-on to Metformin Study (EMPA-REG MET) Add-on to Basal Insulin Study (EMPA-REG BASAL) Pooled Analysis of Efficacy and Effects on Blood Pressure and Lipids Pooled Analysis of Genital Infections and Urinary Tract Infections Summary and Next Steps Lilly Diabetes 24 24
25 Study Design EMPA-REG BASAL (Phase III, Add-on to basal insulin) Empagliflozin EMPA-REG BASAL Insulin stable Insulin titration Key eligibility: HbA 1c > 7% and 10.0% Placebo n = 170 Screening n = ~ 985 Placebo run-in period (2 weeks) Randomization Empagliflozin 10 mg n = 169 Post-treatment follow-up (4 weeks) Empagliflozin 25 mg n = weeks 60 weeks Poster 1102-P American Diabetes Association (ADA) 25
26 Empagliflozin EMPA-REG BASAL HbA1c Change from Baseline at Week 18 Primary Efficacy Endpoint was Met Empagliflozin Comparison with placebo 0.2 Placebo (N = 125) 10 mg (N =132) 25 mg (N = 117) *Confirmatory tests; p< Adjusted mean (SE) change from baseline in HbA1c (%) Mean baseline: 8.10% 8.26% 8.34% -0.56% * -0.70% * FAS 18-week completers (LOCF-18) Poster 1102-P American Diabetes Association (ADA) 26
27 Empagliflozin EMPA-REG BASAL Summary of Adverse Events (AEs) (78 Weeks) N (%) Placebo Empa 10 mg Empa 25 mg Number of patients Patients with any AE(s) 148 (87.1) 143 (84.6) 135 (87.1) Patients with investigator defined drug related AE(s)* Patients with AE(s) leading to discontinuation of trial drug 52 (30.6) 65 (38.5) 68 (43.9) 13 (7.6) 19 (11.2) 20 (12.9) Patients with serious AE(s) 28 (16.5) 28 (16.6) 28 (18.1) * The 5 most common investigator-defined drug-related AEs were urinary tract infection, hyperglycemia, hypoglycemia, dizziness, and polyuria Poster 1102-P American Diabetes Association (ADA) 27
28 AEs of Special Interest: Hypoglycemic Events Add-on to Basal Insulin (78 Weeks) Empagliflozin EMPA-REG BASAL N (%) Placebo Empagliflozin 10 mg Empagliflozin 25 mg Number of patients Patients with confirmed hypoglycemic AEs 60 (35.3) 61 (36.1) 56 (36.1) Events requiring assistance (1) Poster 1102-P American Diabetes Association (ADA) 28
29 Empagliflozin POOLED ANALYSIS Empagliflozin Presentation Agenda Overview: SGLT2 inhibition and Empagliflozin Monotherapy Study (EMPA-REG MONO) Add-on to Metformin Study (EMPA-REG MET) Add-on to Basal Insulin Study (EMPA-REG BASAL) Pooled Analysis of Efficacy and Effects on Blood Pressure and Lipids Pooled Analysis of Genital Infections and Urinary Tract Infections Summary and Next Steps Lilly Diabetes 29 29
30 Pooled Efficacy Data from Four Pivotal Phase III Trials (EMPA-REG MONO, MET, MET + SU, PIO) Empagliflozin POOLED ANALYSIS Placebo (n=825) Empagliflozin 10 mg (n=831) Empagliflozin 25 mg (n=821) HbA 1c (%) Baseline (SE) 8.02 (0.03) 7.98 (0.03) 7.96 (0.03) Change from baseline at week 24 (SE) (0.03) (0.03) (0.03) Difference vs placebo (95% CI) (-0.69, -0.55)*** (-0.75, -0.61)*** FPG (mg/dl) Baseline (SE) (1.3) (1.2) (1.2) Change from baseline at week 24 (SE) 7.4 (1.0) (1.0) (1.0) Difference vs placebo (95% CI) (-30.7, -25.1)*** (-33.4, -27.8)*** Body weight (kg) Baseline (SE) (0.66) (0.65) (0.66) Change from baseline at week 24 (SE) (0.09) (0.09) (0.09) Difference vs placebo (95% CI) Full analysis set (all randomized and treated patients who had a baseline HbA 1c value). Inclusion criteria: HbA1c 7.0% to 10.0%. Treated set (all patients treated with at 1 dose of randomized study medication). *p<0.05 vs placebo; **p<0.01 vs placebo; ***p<0.001 vs placebo. Poster 69-LB American Diabetes Association (ADA) (-2.05, -1.57)*** (-2.25, -1.76)*** 30
31 Empagliflozin POOLED ANALYSIS Pooled Blood Pressure Data from Four Pivotal Phase III Trials (EMPA-REG MONO, MET, MET + SU, PIO) Changes in systolic blood pressure from baseline Overall population Changes in systolic blood pressure from baseline Population uncontrolled BP (SBP 130 mmhg or DBP 80 mmhg at baseline) Adjusted mean (SE) change from baseline in SBP (mmhg) Mean baseline * -6 * Placebo (n=825) Empagliflozin 10 mg (n=831) Empagliflozin 25 mg (n=821) *p<0.001 vs. placebo Adjusted mean (SE) change from baseline in SBP (mmhg) *p<0.001 vs. placebo -2.5 Mean baseline * Placebo (n=501) -7.7 * Empagliflozin 10 mg (n=517) Empagliflozin 25 mg (n=506) Poster 69-LB American Diabetes Association (ADA) 31
32 Empagliflozin POOLED ANALYSIS Pooled Blood Lipids Data from Four Pivotal Phase III Trials (EMPA-REG MONO, MET, MET + SU, PIO) Total cholesterol LDL-cholesterol HDL-cholesterol Triglycerides Adjusted mean (SE) change from baseline (mg/dl) * * * Placebo (N=816) Empagliflozin 10 mg (N=816) Empagliflozin 25 mg (N=818) *p<0.001 vs. placebo; p=0.008 vs. placebo; p=0.011 vs. placebo; p=0.052 vs. placebo; p=0.060 vs. placebo; p=0.321 vs. placebo # For LDL-cholesterol analyses, N=804 for placebo, N=793 for empagliflozin 10 mg and N=800 for empagliflozin 25 mg Poster 69-LB American Diabetes Association (ADA) 32
33 Empagliflozin POOLED ANALYSIS Empagliflozin Presentation Agenda Overview: SGLT2 inhibition and Empagliflozin Monotherapy Study (EMPA-REG MONO) Add-on to Metformin Study (EMPA-REG MET) Add-on to Basal Insulin Study (EMPA-REG BASAL) Pooled Analysis of Efficacy and Effects on Blood Pressure and Lipids Pooled Analysis of Genital Infections and Urinary Tract Infections Summary and Next Steps Lilly Diabetes 33 33
34 Empagliflozin POOLED ANALYSIS Pooled data on Urinary Tract Infections (UTIs) and Genital Infections (GI) (EMPA-REG MONO, MET, MET + SU, PIO) Placebo (n=825) Events consistent with UTIs Empagliflozin 10 mg (n=830) Empagliflozin 25 mg (n=822) Patients with events consistent with UTI, n (%) 68 (8.2) 77 (9.3) 62 (7.5) Male, n/n (%) 16/424 (3.8) 9/463 (1.9) 5/464 (1.1) Female, n/n (%) 52/401 (13.0) 68/367 (18.5) 57/358 (15.9) Patients with events consistent with UTI leading to treatment discontinuation, n (%) 1 (0.1) 2 (0.2) 1 (0.1) Events consistent with GIs Patients with events consistent with genital infection, n (%) 6 (0.7) 35 (4.2) 30 (3.6) Male, n/n (%) 2/424 (0.5) 12/463 (2.6) 5/464 (1.1) Female, n/n (%) 4/401 (1.0) 23/367 (6.3) 25/358 (7.0) Patients with events leading to treatment discontinuation, n (%) 0 1 (0.1) 2 (0.2) Poster 74-LB American Diabetes Association (ADA) 34
35 Empagliflozin Empagliflozin Presentation Agenda Overview: SGLT2 inhibition and Empagliflozin Monotherapy Study (EMPA-REG MONO) Add-on to Metformin Study (EMPA-REG MET) Add-on to Basal Insulin Study (EMPA-REG BASAL) Pooled Analysis of Efficacy and Effects on Blood Pressure and Lipids Pooled Analysis of Genital Infections and Urinary Tract Infections Summary and Next Steps Lilly Diabetes 35 35
36 Empagliflozin Summary of Clinical Data Efficacy Reductions in HbA1c in patients with type 2 diabetes and various antihyperglycemic background therapies Decrease in body weight Reductions in systolic blood pressure, which were larger in patients who were not controlled for blood pressure at baseline Safety Increase in the incidence of genital infections in both genders Overall similar incidences of urinary tract infections with empagliflozin and placebo. However, in women higher incidences were observed compared to placebo Increases in LDL and HDL cholesterol Incidence of hypoglycemia similar to placebo, except when used in combination with sulphonylurea where an increased incidence compared to placebo was observed Lilly Diabetes 36 36
37 Empagliflozin Next Steps Submission of empagliflozin in the U.S. and EU occurred in the first quarter of this year Plan to submit in Japan later this year Cardiovascular Outcome Study (EMPA-REG OUTCOME) ongoing, expected to complete 2018 Fixed-dose combination (FDCs) with metformin and with linagliptin under development Lilly Diabetes 37 37
38 Dulaglutide Sherry Martin, M.D. Senior Medical Director, Lilly Diabetes *The safety and efficacy of dulaglutide has not been established. There is no guarantee that dulaglutide will receive regulatory approval and become commercially available for the uses being investigated.
39 Dulaglutide Dulaglutide Presentation Agenda Overview: Dulaglutide s Clinical Development Program AWARD-5: Dulaglutide and Comparator Sitagliptin AWARD-1: Dulaglutide and Comparator Exenatide AWARD-3: Dulaglutide and Comparator Metformin Pre-clinical Toxicology Data: Primate Study Summary and Next Steps Lilly Diabetes 39
40 Dulaglutide Dulaglutide Presentation Agenda Overview: Dulaglutide s Clinical Development Program AWARD-5: Dulaglutide and Comparator Sitagliptin AWARD-1: Dulaglutide and Comparator Exenatide AWARD-3: Dulaglutide and Comparator Metformin Pre-clinical Toxicology Data: Primate Study Summary and Next Steps Lilly Diabetes 40
41 Dulaglutide Dulaglutide A recombinant GLP-1 Fc fusion protein linking a human GLP-1 peptide analog and a variant of a human IgG4 Fc fragment 1,2 Extended plasma half-life (~5 days) Decreased renal clearance Low immunogenic potential Once-weekly dosing Solution injection: no reconstitution needed GLP-1 analog Linker Modified IgG4 Fc domain 1. Glaesner et al. Diabetes Metab Res Rev 2010;26(4): Data on file, Eli Lilly and Company and/or one of its subsidiaries. Lilly Diabetes 41
42 Dulaglutide Dulaglutide: Phase 3 Development Program 5 pivotal studies, AWARD 1 5 Long-term Phase 3 cardiovascular outcome study, REWIND, currently enrolling patients 3 ongoing Phase 3b studies: AWARD-6 (H2H Lira), AWARD-7 (CKD), AWARD-8 (Add-on SU) Study AWARD-1 Description Add-on to metformin + TZD, double blind vs. placebo, open label vs. exenatide Trial completion Q AWARD-2 Add-on to metformin + sulfonylurea, open label vs. glargine Q AWARD-3 Monotherapy, double blind vs. metformin Q AWARD-4 Combination with mealtime insulin (Humalog), open label vs. glargine Q AWARD-5 REWIND Adaptive / seamless Phase 2/3 trial, add-on to metformin, double blind vs. placebo, double blind vs. sitagliptin (dose-finding trial) Double-blind RCT to assess the CV effects of dulaglutide vs. placebo when added to existing antihyperglycemic regimen (N=~9600) Q Event-driven AWARD, Assessment of Weekly AdministRation of LY in Diabetes REWIND, Researching Cardiovascular Events with a Weekly INcretin in Diabetes = presented today Lilly Diabetes 42
43 Dulaglutide Dulaglutide Presentation Agenda Overview: Dulaglutide s Clinical Development Program AWARD-5: Dulaglutide and Comparator Sitagliptin AWARD-1: Dulaglutide and Comparator Exenatide AWARD-3: Dulaglutide and Comparator Metformin Pre-clinical Toxicology Data: Primate Study Summary and Next Steps Lilly Diabetes 43
44 Dulaglutide AWARD-5 An Adaptive, Double-blind Phase 3 Study Key Inclusion criteria: Diet or exercise, monotherapy (MET or OAM), or combination therapy (MET+1 OAM) A1C 7.0% and 9.5% Dose Finding Dulaglutide 0.25 mg 0.50 mg Decision Point c 52 week analysis 104 week analysis Metformin b 1.0 mg 2.0 mg 3.0 mg Placebo d Dulaglutide 0.75 mg once weekly Dulaglutide 1.5 mg once weekly Sitagliptin 100 mg once daily Sitagliptin 100 mg once daily Safety Follow-up Study Period Treatment Week Lead in -11 a 0 Poster 71-OR American Diabetes Association (ADA) Treatment Period Randomization e Primary Time Point Final Time Point a Lead-in period lasted from 2 weeks up to 11 weeks b Metformin concomitant therapy from lead-in period through treatment period c All patients on non-selected arms were discontinued d After 26 weeks, patients in the placebo arm transitioned to sitagliptin (100 mg/day) in a blinded fashion e Randomization, after dose selection, used a fixed allocation scheme (2:2:2:1 for dulaglutide 0.75 mg:dulaglutide 1.5 mg:sitagliptin:placebo/sitagliptin) Lilly Diabetes 44
45 Dulaglutide AWARD-5 A1C Change from Baseline Baseline A1C = 8.1% 0.2 Week 26 Week 52 A1C, Change from Baseline (%, LS Mean ± SE) , # -1.01, # * (-0.87, -0.55) DU 1.5 mg DU 0.75 mg SITA PL Poster 71-OR American Diabetes Association (ADA) *p< sitagliptin vs placebo # p<0.001 dulaglutide vs sitagliptin ITT, ANCOVA using LOCF analysis Multiplicity adjusted p-values a p<0.001, dulaglutide vs placebo p<0.001, dulaglutide vs sitagliptin a 1-sided p-value adjusted for multiplicity, based on tree gatekeeping strategy Lilly Diabetes 45
46 Dulaglutide AWARD-5 A1C Targets Achieved at 52 Weeks 70 Percent of Patients Achieving A1C Target, % # 58 # # 42 # DU 1.5 mg DU 0.75 mg SITA 10 0 <7.0% 6.5% # p<0.001 vs sitagliptin ITT, Logistic Regression using LOCF analysis Poster 71-OR American Diabetes Association (ADA) Lilly Diabetes 46
47 Dulaglutide AWARD-5 Fasting Plasma Glucose Change Over Time Baseline FPG = 175 mg/dl 10 FPG, Change from Baseline (mg/dl, LS Mean ± SE) * * #, * #, * * #, * * #, * # # DU 1.5 mg DU 0.75 mg SITA PL -50 #, * #, * #, * # #, * # *p<0.05 vs placebo # p<0.001 vs sitagliptin ITT, MMRM analysis, FPG (central laboratory) Weeks Poster 71-OR American Diabetes Association (ADA) Lilly Diabetes 47
48 Dulaglutide AWARD-5 Weight Change Over Time Baseline Weight = 86.4 kg Weight, Change from Baseline (kg, LS Mean ± SE) #, * #, * #, * #, * #, * #, * T T #, * # # DU 1.5 mg DU 0.75 mg SITA PL -4 *p<0.05 vs placebo # p<0.05 vs sitagliptin ITT, MMRM analysis #, * # Weeks # Poster 71-OR American Diabetes Association (ADA) Lilly Diabetes 48
49 Dulaglutide AWARD-5 Adverse Events/Hypoglycemia 52 Weeks DU 1.5 mg N = 304 DU 0.75 mg N = 302 SITA N = 315 Any AE, n (%) 233 (76.6) 231 (76.5) 219 (69.5) Gastrointestinal AE, n (%) Nausea 53 (17.4)* 42 (13.9)* 16 (5.1) Diarrhea 44 (14.5)* 30 (9.9)* 9 (2.9) Vomiting 39 (12.8)* 23 (7.6)* 7 (2.2) Injection site reaction, n (%) 3 (1.0) 3 (1.0) 3 (1.0) Hypoglycemia a ( 70 mg/dl) 104 Weeks Total (events/pt/year), mean (SD) 0.4 (1.6) 0.3 (2.6) 0.1 (1.1) Severe hypoglycemia, n (%) 0 (0.0) 0 (0.0) 0 (0.0) *p<0.001 for dulaglutide vs sitagliptin a Statistical significance was not assessed for hypoglycemia b All cases adjudicated as Acute DU 1.5 mg/du 0.75 mg N = 606 SITA N = 315 Pancreatitis, n (n/1000 pt yrs) 0 (0.0) 3 b (4.7) Pancreatic cancer, n 0 0 Poster 71-OR American Diabetes Association (ADA) Lilly Diabetes 49
50 Dulaglutide Dulaglutide Presentation Agenda Overview: Dulaglutide s Clinical Development Program AWARD-5: Dulaglutide and Comparator Sitagliptin AWARD-1: Dulaglutide and Comparator Exenatide AWARD-3: Dulaglutide and Comparator Metformin Pre-clinical Toxicology Data: Primate Study Summary and Next Steps Lilly Diabetes 50
51 Dulaglutide AWARD-1 Study Design Key inclusion criteria: Diagnosed T2DM A1C 7% BMI 23 and 45 kg/m 2 Stable body weight (±5%) for >3 months Key exclusion criteria: T1DM A1C 6.5% 1 week before randomization Signs, symptoms, and/or history of pancreatitis Elevated serum calcitonin ( 20 pcg/ml) Metformin & Pioglitazone a Placebo b Dulaglutide 1.5 mg Dulaglutide 0.75 mg *Exenatide BID (Open-label) Dulaglutide 1.5 mg Dulaglutide 0.75 mg Safety Follow-up Lead In Treatment Period Follow-up Week Randomization Primary Time Point Final Time Point Poster 66-OR American Diabetes Association (ADA) Rescue therapy initiated for prespecified thresholds for severe, persistent hyperglycemia a All patients start MET and pioglitazone during the lead-in period and continue for the duration of the trial b PL patients continued until Week 26; at that time, PL patients were randomized to DU 0.75 mg or 1.5 mg * First four weeks exenatide 5 µg BID; remaining study duration exenatide 10 µg BID Lilly Diabetes 51
52 Dulaglutide AWARD-1 A1C Change from Baseline Baseline A1C = 8.07% Week 26 A1C, Change from Baseline (%, LS Mean ± SE) , * DU 1.5 mg DU 0.75 mg EX BID PL Poster 66-OR American Diabetes Association (ADA) (-1.22, -0.88) * p<0.001, superiority vs EX BID 10 µg a ; *p<0.001, superiority vs PL a, p<0.001 vs PL a 1-sided p-value adjusted for multiplicity, based on a procedure to control Type 1 error ITT without post-rescue values, ANCOVA using LOCF analysis Lilly Diabetes 52
53 Dulaglutide AWARD-1 A1C Target Achieved at 26 Weeks 90 Percent of Patients Achieving A1C Target, % *, # 79 *, # *, # 64 *, # DU 1.5 mg DU 0.75 mg EX BID PL 10 0 <7.0% 6.5% * p<0.001 DU vs PL; # p DU vs EX; p<0.01 EX vs PL ITT without post-rescue values, Logistic Regression using LOCF analysis Poster 66-OR American Diabetes Association (ADA) Lilly Diabetes 53
54 Dulaglutide AWARD-1 Fasting Serum Glucose Change Over Time to 52 Weeks Baseline FSG = 162 mg/dl DU 1.5 mg 0 DU 0.75 mg FSG, Change from Baseline (mg/dl, LS Mean ± SE) * *, # *, # * *, # *, # * *, # *, # * *, # *, # * *, # *, # # # EX BID PL Weeks *p<0.001 vs PL; # p<0.001 vs EX BID; p<0.05 vs EX BID ITT without post-rescue values, MMRM analysis Poster 66-OR American Diabetes Association (ADA) Lilly Diabetes 54
55 Dulaglutide AWARD-1 Weight Change Over Time to 52 Weeks Baseline Weight = kg DU 1.5 mg DU 0.75 mg EX BID Weight, Change from Baseline (kg, LS Mean ± SE) * * *, # * *, # * * *, # *, # * * # # PL -2.0 *, # *, # * * Poster 66-OR American Diabetes Association (ADA) * p<0.05 vs PL; # p<0.05 vs EX BID ITT without post-rescue values, MMRM analysis Weeks Lilly Diabetes 55
56 Dulaglutide AWARD-1 Adverse Events/Hypoglycemia 26 Weeks DU 1.5 mg N = 279 DU 0.75 mg N = 280 EX BID N = 276 PL N = 141 Any AE, n (%) 215 (77.1) 199 (71.1) 198 (71.7) 104 (73.8) Gastrointestinal AE, n (%) Nausea 78 (28.0) * 45 (16.1) *,# 71 (25.7) * 8 (5.7) Vomiting 47 (16.8) *,# 17 (6.1) *,# 30 (10.9) * 2 (1.4) Diarrhea 31 (11.1) 22 (7.9) 16 (5.8) 8 (5.7) Injection site reaction, n (%) 8 (2.9) 10 (3.6) 13 (4.7) 2 (1.4) Hypoglycemia ( 70 mg/dl) Total (events/pt/year), mean (SD) 0.5 (2.3) 1.1 (5.9) 1.5 (5.7) 0.4 (2.6) Severe Hypoglycemia, n (%) Weeks DU 1.5 mg/du 0.75 mg N = 559 * p<0.05 vs PL; # p<0.05 vs EX BID a This case adjudicated as Chronic EX BID N = 276 PL N = 141 Pancreatitis, n (n/1000 pt yrs) 1 a (1.8) 0 (0.0) 0 (0.0) Pancreatic cancer, n Poster 66-OR American Diabetes Association (ADA) Lilly Diabetes 56
57 Dulaglutide Dulaglutide Presentation Agenda Overview: Dulaglutide s Clinical Development Program AWARD-5: Dulaglutide and Comparator Sitagliptin AWARD-1: Dulaglutide and Comparator Exenatide AWARD-3: Dulaglutide and Comparator Metformin Pre-clinical Toxicology Data: Primate Study Summary and Next Steps Lilly Diabetes 57
58 Dulaglutide AWARD-3 Study Design Key inclusion criteria: T2DM 3 months and 5 years A1C 6.5% and 9.5% Treatment naïve or on 1 OAM (except TZDs) low dose for 3 months BMI 23 and 45 kg/m 2 Stable body weight for 3 months Key exclusion criteria: T1DM Signs, symptoms, and/or history of pancreatitis Elevated serum calcitonin 20 pg/ml Diet and exercise Dulaglutide 0.75 mg + Oral placebo Dulaglutide 1.5 mg + Oral placebo Injectable placebo + Oral metformin* Safety Follow-up Lead in Treatment Period Follow-up Week Randomization Primary Time Point Final Time Point * Patients received 2000 mg/day or 1500 mg/day according to tolerability Rescue therapy initiated for prespecified thresholds for severe, persistent hyperglycemia Poster 69-OR American Diabetes Association (ADA) Lilly Diabetes 58
59 Dulaglutide AWARD-3 A1C Change from Baseline Baseline A1C = 7.6% -0.0 Week 26 Week 52 DU 1.5 mg DU 0.75 mg A1C, Change from Baseline (%, LS Mean ± SE) MET (-0.36, -0.08) Poster 69-OR American Diabetes Association (ADA) Adjusted p-values a p<0.025, noninferiority vs metformin; p<0.025, superiority vs metformin a 1-sided p-value adjusted for multiplicity, based on a procedure to control Type 1 error ITT without post-rescue values, ANCOVA using LOCF analysis Lilly Diabetes 59
60 Dulaglutide AWARD-3 A1C Targets Achieved at 26 Weeks # 62 # 63 DU 1.5 mg Percent of Patients Achieving A1C Target, % ## 46 # DU 0.75 mg MET 0 <7.0% 6.5% # p<0.05 vs. metformin; ## p<0.001 vs metformin ITT without post-rescue values, Logistic Regression using LOCF analysis Poster 69-OR American Diabetes Association (ADA) Lilly Diabetes 60
61 Dulaglutide AWARD-3 Weight Change Over Time Baseline Weight = kg 1 Weight, Change from Baseline (kg, LS Mean ± SE) ## ## # # p<0.05 vs metformin; ## p<0.001 vs metformin ITT without post-rescue values, MMRM analysis # Weeks Weeks ## ## DU 1.5 mg DU 0.75 mg MET Poster 69-OR American Diabetes Association (ADA) Lilly Diabetes 61
62 Dulaglutide AWARD-3 Adverse Events/Hypoglycemia at 52 Weeks DU 1.5 mg N = 269 DU 0.75 mg N = 270 MET N = 268 Any AE a, n (%) 179 (66.5) 177 (65.6) 170 (63.4) Gastrointestinal AE a, n (%) Nausea 53 (19.7) 31 (11.5) 43 (16.0) Diarrhea 30 (11.2) 21 (7.8) 37 (13.8) Vomiting 26 (9.7) 20 (7.4) 13 (4.9) Injection site reactions a, n (%) 10 (3.7) 6 (2.2) 4 (1.5) Hypoglycemia a ( 70 mg/dl) Total (events/pt/year), mean (SD) 0.89 (9.02) 0.47 (2.26) 0.29 (0.98) Severe hypoglycemia, n (%) 0 (0.0) 0 (0.0) 0 (0.0) DU 1.5 mg/du 0.75 mg N= 539 MET N = 268 Pancreatitis, n (n/1000 pt yrs) 0 (0.0) 0 (0.0) Pancreatic cancer, n 0 0 a No significant difference between DU and MET Poster 69-OR American Diabetes Association (ADA) Lilly Diabetes 62
63 Dulaglutide TOXICOLOGY Dulaglutide Presentation Agenda Overview: Dulaglutide s Clinical Development Program AWARD-5: Dulaglutide and Comparator Sitagliptin AWARD-1: Dulaglutide and Comparator Exenatide AWARD-3: Dulaglutide and Comparator Metformin Pre-clinical Toxicology Data: Primate Study Summary and Next Steps Lilly Diabetes 63
64 Dulaglutide TOXICOLOGY Evaluation of Serum Amylase and Lipase, and Expanded Pancreatic Histology in Monkeys Following 12 Month Administration of Dulaglutide Study Design Cynomolgus male monkeys (n=20 controls, n=19 treated); administration of twiceweekly dulaglutide doses at 500-fold the human exposure for 52 weeks Systematic micro-sections evaluated from head, body, and tail of pancreas (posteuthanasia) Examination of slides by board-certified veterinary pathologists and a human pancreatic pathologist Results No pancreatic inflammation or necrosis No pancreatic cancer or precursor changes (no ductal proliferation) Increase in goblet cells (mucin-producing) in 4/19 DU treated monkeys; not considered adverse to monkeys No increase in pancreatic enzymes, treated compared to controls Conclusion: Chronic dosing of dulaglutide in non-diabetic primates did not induce inflammatory or preneoplastic changes of the exocrine pancreas Lilly Diabetes 64
65 Dulaglutide Dulaglutide Presentation Agenda Overview: Dulaglutide s Clinical Development Program AWARD-5: Dulaglutide and Comparator Sitagliptin AWARD-1: Dulaglutide and Comparator Exenatide AWARD-3: Dulaglutide and Comparator Metformin Pre-clinical Toxicology Data: Primate Study Summary and Next Steps Lilly Diabetes 65
66 Dulaglutide Summary and Next Steps Efficacy Dulaglutide demonstrated significant, sustained glycemic lowering Superior to active comparators (sitagliptin, exenatide, and metformin) as measured by A1C reduction, in studies ranging from 52 weeks to 104 weeks Significantly more patients achieved A1C goals than active comparators Majority of significant improvement in fasting glucose demonstrated by first 2 weeks Dulaglutide demonstrated dose-dependent, sustained weight loss Safety Low rates of hypoglycemia (less than 2 events/patient/year for each trial and no severe hypoglycemia) Injection site reactions were infrequent (< 5%) The most common treatment emergent adverse events were gastrointestinal in nature, including nausea, diarrhea and vomiting Nausea was mostly mild to moderate, typically occurred in the first few weeks of therapy, and was transient Next Steps Submission planned to regulatory authorities in 2013 Lilly Diabetes 66
67 Questions and Answers
Harmony Clinical Trial Medical Media Factsheet
Overview Harmony is the global Phase III clinical trial program for Tanzeum (albiglutide), a product developed by GSK for the treatment of type 2 diabetes. The comprehensive program comprised eight individual
More informationClinical Assistant Professor. Clinical Pharmacy Specialist Wesley Family Medicine Residency Program. Objectives
What s New in Diabetes Medications? Matthew Kostoff, PharmD, BCPS, BCACP Clinical Assistant Professor Clinical Pharmacy Specialist Wesley Family Medicine Residency Program Objectives Discuss new literature
More information嘉 義 長 庚 醫 院 藥 劑 科 Speaker : 翁 玟 雯
The Clinical Efficacy and Safety of Sodium Glucose Cotransporter-2 (SGLT2) Inhibitors in Adults with Type 2 Diabetes Mellitus 嘉 義 長 庚 醫 院 藥 劑 科 Speaker : 翁 玟 雯 Diabetes Mellitus : A group of diseases characterized
More informationNovel Trial Designs in T2D to Satisfy Regulatory Requirements for CV Safety
Novel Trial Designs in T2D to Satisfy Regulatory Requirements for CV Safety Anders Svensson MD, PhD Head of Global Clinical Development Metabolism, F Hoffmann LaRoche Ltd. Basel, Switzerland Overview of
More informationCara Liday, PharmD, CDE Associate Professor, Idaho State University Clinical Pharmacist and CDE, InterMountain Medical Center Pocatello, ID The planners and presenter have disclosed no conflict of interest,
More informationlinagliptin, 5mg film-coated tablet (Trajenta ) SMC No. (746/11) Boehringer Ingelheim / Eli Lilly and Company Ltd
linagliptin, 5mg film-coated tablet (Trajenta ) SMC No. (746/11) Boehringer Ingelheim / Eli Lilly and Company Ltd 09 December 2011 The Scottish Medicines Consortium (SMC) has completed its assessment of
More informationInsulin or GLP1 How to make this choice in Practice. Tara Kadis Lead Nurse - Diabetes & Endocrinology Mid Yorkshire Hospitals NHS Trust
Insulin or GLP1 How to make this choice in Practice Tara Kadis Lead Nurse - Diabetes & Endocrinology Mid Yorkshire Hospitals NHS Trust Workshop Over View Considerations/barriers to treatments in type 2
More informationComparing Medications for Adults With Type 2 Diabetes Focus of Research for Clinicians
Clinician Research Summary Diabetes Type 2 Diabetes Comparing Medications for Adults With Type 2 Diabetes Focus of Research for Clinicians A systematic review of 166 clinical studies published between
More informationManagement of Diabetes: A Primary Care Perspective. Presentation Outline
Management of Diabetes: A Primary Care Perspective Robert B. Baron MD MS Professor and Associate Dean UCSF School of Medicine Declaration of full disclosure: No conflict of interest Presentation Outline
More informationINSULIN TREATMENT FOR TYPE 2 DIABETES MANAGEMENT
INSULIN TREATMENT FOR TYPE 2 DIABETES MANAGEMENT APIRADEE SRIWIJITKAMOL DIVISION OF ENDOCRINOLOGY AND METABOLISM DEPARTMENT OF MEDICINE FACULTY OF MEDICINE SIRIRAJ HOSPITOL QUESTION 1 1. ท านเคยเป นแพทย
More informationDiabetes Mellitus 1. Chapter 43. Diabetes Mellitus, Self-Assessment Questions
Diabetes Mellitus 1 Chapter 43. Diabetes Mellitus, Self-Assessment Questions 1. A 46-year-old man presents for his annual physical. He states that he has been going to the bathroom more frequently than
More informationSponsor. Novartis Generic Drug Name. Vildagliptin. Therapeutic Area of Trial. Type 2 diabetes. Approved Indication. Investigational.
Clinical Trial Results Database Page 1 Sponsor Novartis Generic Drug Name Vildagliptin Therapeutic Area of Trial Type 2 diabetes Approved Indication Investigational Study Number CLAF237A2386 Title A single-center,
More informationType 2 Diabetes. Aims and Objectives. What did you consider? Case Study One: Miss S. Which to choose?!?! Modes of Action
Aims and Objectives This session will outline the increasing complexities of diabetes care, and the factors that differentiate the combinations of therapy, allowing individualisation of diabetes treatment.
More informationNCT00272090. sanofi-aventis HOE901_3507. insulin glargine
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription Sponsor/company: Generic drug name:
More informationDavid Shu, MD, FRCPC Endocrinology, Royal Columbian Hospital October 8 th, 2010
David Shu, MD, FRCPC Endocrinology, Royal Columbian Hospital October 8 th, 2010 Objectives At the end of the talk, the participants will be able to: 1. Identify the increasing prevalence of type 2 diabetes
More informationPharmaceutical Management of Diabetes Mellitus
1 Pharmaceutical Management of Diabetes Mellitus Diabetes Mellitus (cont d) Signs and symptoms 2 Elevated fasting blood glucose (higher than 126 mg/dl) or a hemoglobin A1C (A1C) level greater than or equal
More informationType 2 Diabetes. Tabinda Dugal GP Day 4/05/16
Type 2 Diabetes Tabinda Dugal GP Day 4/05/16 Diabetes Diabetes.a growing health crisis in Britain 869m per year 10% of NHS budget Projections.. 5 million by 2025 Youngest patient? T2DM Type 2 diabetes
More informationThe basal plus strategy. Denis Raccah, MD, PhD Professor of Medicine University Hospital Sainte Marguerite Marseille FRANCE
The basal plus strategy Denis Raccah, MD, PhD Professor of Medicine University Hospital Sainte Marguerite Marseille FRANCE ADA/EASD guidelines recommend use of basal insulin as early as the second step
More informationAdd: 2 nd generation sulfonylurea or glinide or Add DPP-4 inhibitor Start or intensify insulin therapy if HbA1c goals not achieved with the above
Guidelines for Type Diabetes - Diagnosis Fasting Plasma Glucose (confirm results if borderline) HbAIC Normal FPG < 00 < 5.5 Impaired Fasting Glucose (IFG) 00 to < 5.7%-.5% Diabetes Mellitus (or random
More informationHow To Treat Diabetes
Overview of Diabetes Medications Marie Frazzitta DNP, FNP c, CDE, MBA Senior Director of Disease Management North Shore LIJ Health Systems Normal Glucose Metabolism Insulin is produced by beta cells in
More informationDiabetes: When To Treat With Insulin and Treatment Goals
Diabetes: When To Treat With Insulin and Treatment Goals Lanita. S. White, Pharm.D. Director, UAMS 12 th Street Health and Wellness Center Assistant Professor of Pharmacy Practice, UAMS College of Pharmacy
More informationWhich drugs should be used to treat diabetes in cirrhotic patients?
Which drugs should be used to treat diabetes in cirrhotic patients? Frankfurt am Main 10-12 September 2015 Jörg Bojunga Medizinische Klinik I Johann Wolfgang Goethe-Universität Frankfurt am Main Significance
More informationEffect of liraglutide on body weight in overweight or obese subjects with type 2 diabetes: SCALE - Diabetes
Effect of liraglutide on body weight in overweight or obese subjects with type 2 diabetes: SCALE - Diabetes This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim
More informationGuidelines for Type 2 Diabetes Diagnosis
Guidelines for Type 2 Diabetes Diagnosis Fasting Plasma Glucose (in asymptomatic individuals, repeat measurement to confirm the test) Normal FPG < 100 2-hr OGTT < 140 HbA1C < 5.5% Impaired Fasting Glucose
More informationThis clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.
abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the
More informationIMPROVED METABOLIC CONTROL WITH A FAVORABLE WEIGHT PROFILE IN PATIENTS WITH TYPE 2 DIABETES TREATED WITH INSULIN GLARGINE (LANTUS ) IN CLINICAL
464 IMPROVED METABOLIC CONTROL WITH A FAVORABLE WEIGHT PROFILE IN PATIENTS WITH TYPE 2 DIABETES TREATED WITH INSULIN GLARGINE (LANTUS ) IN CLINICAL PRACTICE STEPHAN A SCHREIBER AND ANIKA RUßMAN ABSTRACT
More informationTreatment of Type 2 Diabetes
Improving Patient Care through Evidence Treatment of Type 2 Diabetes This information is based on a comprehensive review of the evidence for best practices in the treatment of type 2 diabetes and is sponsored
More informationType 2 Diabetes - Pros and Cons of Insulin Administration
Do we need alternative routes of insulin administration (inhaled insulin) in Type 2 diabetes? Cons: Suad Efendic Karolinska Institutet, Sweden The Diabetes Management Situation Today Diabetes is a growing
More informationSanofi Reports Positive Phase 3 Results for Toujeo (insulin glargine [rdna origin] injection, 300 U/mL)
PRESS RELEASE Sanofi Reports Positive Phase 3 Results for Toujeo (insulin glargine [rdna origin] injection, 300 U/mL) Meta-analysis of three late-stage trials in people with type 2 diabetes shows decreases
More informationSubcutaneous Infusion of GLP-1 for 7 Days Improves Glycemic Control Over a Broad Dose Range in Patients with Type 2 Diabetes
Subcutaneous Infusion of GLP-1 for 7 Days Improves Glycemic Control Over a Broad Dose Range in Patients with Type 2 Diabetes Mario R. Ehlers, 1,2 Roderick E. Harley, 1 Annette L. Mathisen, 1 Roberta Schneider,
More informationHumulin (LY041001) Page 1 of 1
(LY041001) These clinical study results are supplied for informational purposes only in the interests of scientific disclosure. They are not intended to substitute for the FDA-approved package insert or
More informationCASE B1. Newly Diagnosed T2DM in Patient with Prior MI
Newly Diagnosed T2DM in Patient with Prior MI 1 Our case involves a gentleman with acute myocardial infarction who is newly discovered to have type 2 diabetes. 2 One question is whether anti-hyperglycemic
More informationSystolic Blood Pressure Intervention Trial (SPRINT) Principal Results
Systolic Blood Pressure Intervention Trial (SPRINT) Principal Results Paul K. Whelton, MB, MD, MSc Chair, SPRINT Steering Committee Tulane University School of Public Health and Tropical Medicine, and
More informationOverview and update of modern type 2 Diabetes philosophy and management. Dr Steve Stanaway Consultant Endocrinologist BCU
Overview and update of modern type 2 Diabetes philosophy and management Dr Steve Stanaway Consultant Endocrinologist BCU Diabetes economics 2009: 2.6M adults with DM in UK (90% type 2) 2025: est. > 4M
More informationInitiate Atorvastatin 20mg daily
Type 2 Diabetes Patient Objectives Stopping Smoking BMI > 25 kg m² Control BP to
More informationDiabetes Medications: Insulin Therapy
Diabetes Medications: Insulin Therapy Courtesy Univ Texas San Antonio Eric L. Johnson, M.D. Department of Family and Community Medicine Diabetes and Insulin Type 1 Diabetes Autoimmune destruction of beta
More informationCASE A1 Hypoglycemia in an Elderly T2DM Patient with Heart Failure
Hypoglycemia in an Elderly T2DM Patient with Heart Failure 1 I would like to introduce you to Sophie, an elderly patient with long-standing type 2 diabetes, who has a history of heart failure, a common
More informationNOUVELLLES THERAPIES EN DIABÈTE
1 NOUVELLLES THERAPIES EN DIABÈTE Rémi Rabasa-Lhoret M.D, Ph.D. Endocrinologie Chaire J-A De Sève Professeur agrégé, Département de nutrition, Université de Montréal Directeur Plateforme de Recherche en
More informationType 2 diabetes Definition
Type 2 diabetes Definition Type 2 diabetes is a lifelong (chronic) disease in which there are high levels of sugar (glucose) in the blood. Type 2 diabetes is the most common form of diabetes. Causes Diabetes
More informationMary Bruskewitz APN, MS, RN, BC-ADM Clinical Nurse Specialist Diabetes
Mary Bruskewitz APN, MS, RN, BC-ADM Clinical Nurse Specialist Diabetes Objectives Pathophysiology of Diabetes Acute & Chronic Complications Managing acute emergencies Case examples 11/24/2014 UWHealth
More informationSHORT CLINICAL GUIDELINE SCOPE
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE SHORT CLINICAL GUIDELINE SCOPE 1 Guideline title Type 2 diabetes: newer agents for blood glucose control in type 2 diabetes 1.1 Short title Type 2
More informationType 2 Diabetes Update For 2015
Type 2 Diabetes Update For 2015 Jerry Meece, RPh, CDE, FACA, FAADE Plaza Pharmacy and Wellness Center jmeece12@cooke.net Learning Objectives At the conclusion of this presentation, the participant will
More informationBritni Hebert, MD PGY-1
Britni Hebert, MD PGY-1 Importance of Diabetes treatment Types of treatment Comparison of treatment/article Review Summary Example cases 1 out of 13 Americans have diabetes Complications include blindness,
More informationINSULIN INTENSIFICATION: Taking Care to the Next Level
INSULIN INTENSIFICATION: Taking Care to the Next Level By J. Robin Conway M.D., Diabetes Clinic, Smiths Falls, ON www.diabetesclinic.ca Type 2 Diabetes is an increasing problem in our society, due largely
More informationPharmacological Glycaemic Control in Type 2 Diabetes
Pharmacological Glycaemic Control in Type 2 Diabetes Aim(s) and Objective(s) This guideline aims to offer advice on the pharmacological management for those who require measures beyond diet and exercise
More informationComparative Review of Oral Hypoglycemic Agents in Adults
SECTION 18.5 Comparative Review of Oral Hypoglycemic Agents in Adults Harinder Chahal For WHO Secretariat Table of Contents Acronyms:... 3 I. Background and Rationale for the review:... 4 II. Medications
More informationTYPE 2 DIABETES IN CHILDREN DIAGNOSIS AND THERAPY. Ines Guttmann- Bauman MD Clinical Associate Professor, Division of Pediatric Endocrinology, OHSU
TYPE 2 DIABETES IN CHILDREN DIAGNOSIS AND THERAPY Ines Guttmann- Bauman MD Clinical Associate Professor, Division of Pediatric Endocrinology, OHSU Objectives: 1. To discuss epidemiology and presentation
More informationType II diabetes: How to use the new oral medications
Type II diabetes: How to use the new oral medications A TWO-PART INTERVIEW WITH NANCY J.V. BOHANNON, MD, BY DAVID B. JACK, MD Several new oral drugs have been approved for the management of type II diabetes.
More informationNew Non-Insulin Therapies for Type 2 Diabetes Mellitus
New Non-Insulin Therapies for Type 2 Diabetes Mellitus Ally P.H. Prebtani Associate Professor of Medicine Internal Medicine, Endocrinology & Metabolism McMaster University Canada Disclosure Relationships
More informationA Simplified Approach to Initiating Insulin. 4. Not meeting glycemic goals with oral hypoglycemic agents or
A Simplified Approach to Initiating Insulin When to Start Insulin: 1. Fasting plasma glucose (FPG) levels >250 mg/dl or 2. Glycated hemoglobin (A1C) >10% or 3. Random plasma glucose consistently >300 mg/dl
More informationPrevalence and Characteristics of Low Serum Testosterone Levels in Men with Type 2 Diabetes Mellitus Naïve to Injectable Therapy
Prevalence and Characteristics of Low Serum Testosterone Levels in Men with Type 2 Diabetes Mellitus Naïve to Injectable Therapy International Society for Sexual Medicine 2014 Presenter: Felipe Borges
More informationTreatment Approaches to Diabetes
Treatment Approaches to Diabetes Dr. Sarah Swofford, MD, MSPH & Marilee Bomar, GCNS, CDE Quick Overview Lifestyle Oral meds Injectables not insulin Insulin Summary 1 Lifestyle & DM Getting to the point
More informationCauses, incidence, and risk factors
Causes, incidence, and risk factors Insulin is a hormone produced by the pancreas to control blood sugar. Diabetes can be caused by too little insulin, resistance to insulin, or both. To understand diabetes,
More informationADVANCE: a factorial randomised trial of blood pressure lowering and intensive glucose control in 11,140 patients with type 2 diabetes
ADVANCE: a factorial randomised trial of blood pressure lowering and intensive glucose control in 11,140 patients with type 2 diabetes Effects of a fixed combination of the ACE inhibitor, perindopril,
More informationSponsor Novartis Pharmaceuticals
Clinical Trial Results Database Page 1 Sponsor Novartis Pharmaceuticals Generic Drug Name Indacaterol Therapeutic Area of Trial Chronic Obstructive Pulmonary Disease (COPD) Indication studied: COPD Study
More informationINSULIN AND INCRETIN THERAPIES: WHAT COMBINATIONS ARE RIGHT FOR YOUR PATIENT?
INSULIN AND INCRETIN THERAPIES: WHAT COMBINATIONS ARE RIGHT FOR YOUR PATIENT? MARTHA M. BRINSKO, MSN, ANP-BC CHARLOTTE COMMUNITY HEALTH CLINIC CHARLOTTE, NC Diagnosed and undiagnosed diabetes in the United
More informationInsulin is a hormone produced by the pancreas to control blood sugar. Diabetes can be caused by too little insulin, resistance to insulin, or both.
Diabetes Definition Diabetes is a chronic (lifelong) disease marked by high levels of sugar in the blood. Causes Insulin is a hormone produced by the pancreas to control blood sugar. Diabetes can be caused
More information10/30/2012. Anita King, DNP, RN, FNP, CDE, FAADE Clinical Associate Professor University of South Alabama Mobile, Alabama
Faculty Medications for Diabetes Satellite Conference and Live Webcast Wednesday, November 7, 2012 2:00 4:00 p.m. Central Time Anita King, DNP, RN, FNP, CDE, FAADE Clinical Associate Professor University
More informationDiabetes Mellitus. Melissa Meredith M.D. Diabetes Mellitus
Melissa Meredith M.D. Diabetes mellitus is a group of metabolic diseases characterized by high blood glucose resulting from defects in insulin secretion, insulin action, or both Diabetes is a chronic,
More informationWorkshop A Tara Kadis
Workshop A Tara Kadis Considerations/barriers in decision making about insulin verses GLP-1 use in people with type 2 diabetes Which Insulin regimes should we consider? Diabetes is a progressive multi-system
More informationtrends in the treatment of Diabetes type 2 - New classes of antidiabetic drugs. IAIM, 2015; 2(4): 223-
Review Article Pharmacological trends in the treatment of Diabetes type 2 - New classes of antidiabetic Silvia Mihailova 1*, Antoaneta Tsvetkova 1, Anna Todorova 2 1 Assistant Pharmacist, Education and
More informationDiabetes in Primary Care course MCQ Answers 2016
Diabetes in Primary Care course MCQ Answers 2016 Diagnosis of Diabetes HbA1C should not be used as a diagnostic tool in the following situations: (answer each TRUE or FALSE) 1. Gestational Diabetes TRUE
More informationGlucagon Receptor Antagonist: LGD-6972 Program Overview and Phase 1b Results
Glucagon Receptor Antagonist: LGD-6972 Program Overview and Phase 1b Results American Diabetes Association s 75th Scientific Sessions June 7, 2015 Boston 2 Safe Harbor Statement The following presentation
More informationNewer Anticoagulants and Newer Diabetic Drug Classes. Nicole N. Nguyen, PharmD Senior Clinical Pharmacist Health Care Services August 21, 2013
Newer Anticoagulants and Newer Diabetic Drug Classes Nicole N. Nguyen, PharmD Senior Clinical Pharmacist Health Care Services August 21, 2013 Apixaban Newer Anticoagulants Dabigatran etexilate Rivaroxaban
More informationCME Test for AMDA Clinical Practice Guideline. Diabetes Mellitus
CME Test for AMDA Clinical Practice Guideline Diabetes Mellitus Part I: 1. Which one of the following statements about type 2 diabetes is not accurate? a. Diabetics are at increased risk of experiencing
More informationPEER REVIEW HISTORY ARTICLE DETAILS
PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)
More informationNew and Future Treatments for Diabetes. Mary Charlton Specialty Doctor in Diabetes University Hospital Birmingham BARS Oct 2014
New and Future Treatments for Diabetes Mary Charlton Specialty Doctor in Diabetes University Hospital Birmingham BARS Oct 2014 Conflicts of interest Investigator Carmelina study of Linagliptin (Boehringer
More informationUnderstanding Diseases and Treatments with Canadian Real-world Evidence
Understanding Diseases and Treatments with Canadian Real-world Evidence Real-World Evidence for Successful Market Access WHITEPAPER REAL-WORLD EVIDENCE Generating real-world evidence requires the right
More informationGLP-1 receptor agonists: a review of headto-head
559725TAE0010.1177/2042018814559725Therapeutic Advances in Endocrinology and MetabolismJ. M. Trujillo et al. research-article2014 Therapeutic Advances in Endocrinology and Metabolism Review GLP-1 receptor
More informationEFFIMET 1000 XR Metformin Hydrochloride extended release tablet
BRAND NAME: Effimet XR. THERAPEUTIC CATEGORY: Anti-Diabetic PHARMACOLOGIC CLASS: Biguanides EFFIMET 1000 XR Metformin Hydrochloride extended release tablet COMPOSITION AND PRESENTATION Composition Each
More informationUpdate on the management of Type 2 Diabetes
Update on the management of Type 2 Diabetes Mona Nasrallah M.D Assistant Professor, Endocrinology American University of Beirut 10 th Annual Family Medicine Conference October 14,2011 Global Prevalence
More informationIntensive Insulin Therapy in Diabetes Management
Intensive Insulin Therapy in Diabetes Management Lillian F. Lien, MD Medical Director, Duke Inpatient Diabetes Management Assistant Professor of Medicine Division of Endocrinology, Metabolism, & Nutrition
More informationNew Drugs for the Primary Care Provider: What You Need to Know
New Drugs for the Primary Care Provider: What You Need to Know Faculty Financial Disclosure Gerald W. Smetana, MD, has no financial relationships to disclose. Gerald W. Smetana, MD Beth Israel Deaconess
More informationWhen and how to start insulin: strategies for success in type 2 diabetes
1 When and how to start insulin: strategies for success in type diabetes Treatment of type diabetes in 199: with each step treatment gets more complex Bruce H.R. Wolffenbuttel, MD PhD Professor of Endocrinology
More informationUp to Date for Diabetes: Veronica Piziak MD, PhD Professor of Medicine Texas A&M Emeritus Director of Endocrinology Baylor Scott and White
Up to Date for Diabetes: Veronica Piziak MD, PhD Professor of Medicine Texas A&M Emeritus Director of Endocrinology Baylor Scott and White Objectives: What is New in Therapy How to select medications Disclosures:
More informationCardiovascular Effects of Drugs to Treat Diabetes
Cardiovascular Effects of Drugs to Treat Diabetes Steven E. Nissen MD Chairman, Department of Cardiovascular Medicine Cleveland Clinic Disclosure Consulting: Many pharmaceutical companies Clinical Trials:
More informationBIAsp30 A 1 chieve Tehran 31 July 2015
BIAsp30 A 1 chieve Tehran 31 July 2015 Beginning insulin with biphasic insulin aspart 30: experience from the A 1 chieve study Professor Philip Home Newcastle University Presenter and sponsor duality of
More informationDiabetes Medications. Minal Patel, PharmD, BCPS
Diabetes Medications Minal Patel, PharmD, BCPS Objectives Examine advantages and disadvantages of oral anti-hyperglycemic medications Describe the differences between different classes of insulin Explore
More informationU.S. Scientific Update Aricept 23 mg Tablets. Dr. Lynn Kramer President NeuroScience Product Creation Unit Eisai Inc.
U.S. Scientific Update Aricept 23 mg Tablets Dr. Lynn Kramer President NeuroScience Product Creation Unit Eisai Inc. Unmet Need in Moderate to Severe Alzheimer s Disease (AD) Ongoing clinical deterioration
More informationClinical Study Synopsis for Public Disclosure
abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of the clinical
More informationType 2 Diabetes Medicines: What You Need to Know
Type 2 Diabetes Medicines: What You Need to Know Managing diabetes is complex because many hormones and body processes are at work controlling blood sugar (glucose). Medicines for diabetes include oral
More informationACTOS (pioglitazone HCl) in the Management of Type 2 Diabetes PRODUCT INFORMATION GUIDE
MARCH 2008 PRODUCT INFORMATION GUIDE JIM DOWDALLS / PHOTO RESEARCHERS, INC. ACTOS (pioglitazone HCl) in the Management of Type 2 Diabetes PHG0801 SPECIAL ADVERTISING SECTION This Product Information Guide
More informationSponsor / Company: Sanofi Drug substance(s): HOE901 (insulin glargine)
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription. Sponsor / Company: Sanofi Drug substance(s):
More informationWelchol (colesevelam HCl) Receives FDA Approval to Reduce Blood Glucose in Adults with Type 2 Diabetes
For Immediate Release Company name: DAIICHI SANKYO COMPANY, LIMITED Representative: Takashi Shoda, President and Representative Director (Code no.: 4568, First Section, Tokyo, Osaka and Nagoya Stock Exchanges)
More informationWeek 12 study results
Week 12 study results 15 April 2015 Copyright 2015 Galapagos NV Disclaimer This document may contain certain statements, including forward-looking statements, such as statements concerning the safety and
More informationADJUSTING INSULIN DOSES CONFLICTS OF INTEREST
ADJUSTING INSULIN DOSES CONFLICTS OF INTEREST Vahid Mahabadi, MD Research grants from Sanofi and Amylin Pharmaceutical Companies Mayer B. Davidson, MD Advisory Board Sanofi Pharmaceutical Company Chief
More informationJNC-8 Blood Pressure and ACC/AHA Cholesterol Guideline Updates. January 30, 2014
JNC-8 Blood Pressure and ACC/AHA Cholesterol Guideline Updates January 30, 2014 GOALS Review key recommendations from recently published guidelines on blood pressure and cholesterol management Discuss
More informationThe first endoscopically-delivered device therapy for obese patients with type 2 diabetes
DIABETES WEIGHT ENDOBARRIER THERAPY The first endoscopically-delivered device therapy for obese patients with type 2 diabetes Restore the metabolic health of your patients with EndoBarrier Therapy. Dual
More informationNew and Emerging Diabetes Medications. What do Advanced Practice Nurses Need to Know? Lorraine Nowakowski-Grier,MSN,APRN,BC,CDE
New and Emerging Diabetes Medications What do Advanced Practice Nurses Need to Know? Lorraine Nowakowski-Grier,MSN,APRN,BC,CDE Objectives 1) Describe the clinical indications on select emerging novel diabetes
More informationManaging diabetes in the post-guideline world. Dr Helen Snell Nurse Practitioner PhD, FCNA(NZ)
Managing diabetes in the post-guideline world Dr Helen Snell Nurse Practitioner PhD, FCNA(NZ) Overview Pathogenesis of T2DM Aims of treatment The place of glycaemic control Strategies to improve glycaemic
More informationPrimary Care Type 2 Diabetes Update
Primary Care Type 2 Diabetes Update May 16, 2014 Presented by: Barb Risnes APRN, BC-ADM, CDE Objectives: Discuss strategies to address common type 2 diabetes patient management challenges Review new pharmacological
More informationType 2 Diabetes Prevention and Therapy. Veronica Piziak MD, PhD Scott and White
Type 2 Diabetes Prevention and Therapy Veronica Piziak MD, PhD Scott and White Disclosures: Research support: J&J Objectives: Epidemiology of diabetes Diagnosis of diabetes Treatment goals Every Day in
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Afrezza Page 1 of 6 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Afrezza (human insulin) Prime Therapeutics will review Prior Authorization requests Prior Authorization
More informationNew Treatments for Type 2 Diabetes
New Treatments for Type 2 Diabetes Dr David Hopkins Clinical Director, Division of Ambulatory Care King s College Hospital NHS Foundation Trust Treatments for type 2 diabetes - old & new insulin sulphonylureas
More informationProtein Intake in Potentially Insulin Resistant Adults: Impact on Glycemic and Lipoprotein Profiles - NPB #01-075
Title: Protein Intake in Potentially Insulin Resistant Adults: Impact on Glycemic and Lipoprotein Profiles - NPB #01-075 Investigator: Institution: Gail Gates, PhD, RD/LD Oklahoma State University Date
More informationCancer treatment and diabetes
Cancer treatment and diabetes Dr Daniel Morganstein Consultant Endocrinologist, 1 2 Diabetes and cancer Cancer and its treatment also poses challenges to managing diabetes Surgery Altered appetite Cachexia
More informationHigh Blood Cholesterol
National Cholesterol Education Program ATP III Guidelines At-A-Glance Quick Desk Reference 1 Step 1 2 Step 2 3 Step 3 Determine lipoprotein levels obtain complete lipoprotein profile after 9- to 12-hour
More informationClinical Research on Lifestyle Interventions to Treat Obesity and Asthma in Primary Care Jun Ma, M.D., Ph.D.
Clinical Research on Lifestyle Interventions to Treat Obesity and Asthma in Primary Care Jun Ma, M.D., Ph.D. Associate Investigator Palo Alto Medical Foundation Research Institute Consulting Assistant
More informationDrug Class Review. Newer Diabetes Medications and Combinations
Drug Class Review Newer Diabetes Medications and Combinations Final Streamlined Update 1 Report June 2014 The purpose of Drug Effectiveness Review Project reports is to make available information regarding
More informationPrior Authorization Guideline
Prior Authorization Guideline Guideline: PC - Apidra, Levemir Therapeutic Class: Hormones and Synthetic Substitutes Therapeutic Sub-Class: Antidiabetic Agents Client: CA, CO, NV, OK, OR, WA and AZ Approval
More information