GLP-1 Agonists And Insulin Therapy

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1 GLP-1 Agonists And Insulin Therapy Steven V. Edelman, MD Professor of Medicine University of California San Diego School of Medicine Veterans Affairs Medical Center Founder and Director, Taking Control of Your Diabetes, 51(c) 3

2 Riccardo Perfetti, MD, PhD T2D Type 2 Diabetes A1C HbA1c or Glycated hemoglobin (1) Abstract 278-OR presented at ADA s 71st Scientific Sessions in June 211, and published online in Diabetes, Obesity and Metabolism on May 3, 212 (2) Adapted from IMS data 3) Includes all types of basal insulins Lixisenatide was in-licensed from Zealand Pharma A/S. Lyxumia is the intended trademark for lixisenatide. Lixisenatide is currently not approved or licensed anywhere in the world

3 In patients controlled with basal insulin, PPG not FBG is the major contributor to hyperglycaemia Relative contributions of FBG and PPG hyperglycaemia to overall hyperglycaemia at Week 24/28 in patients receiving insulin glargine (N=1699) % of patients Basal hyperglycaemia Postprandial hyperglycaemia < HbA 1c (%) Targeting FBG and PPG control is essential for optimal clinical outcomes Data are pooled from six similarly designed, randomized, controlled trials of patients with T2DM suboptimally controlled on OADs Riddle et al. Diabetes Care 211;34:258 14

4 Options for additional control beyond basal insulin Prandial insulin Advantages Disadvantages Effective in controlling PPG Increased risk of hypoglycaemia Weight gain GLP-1 receptor agonists Advantages Disadvantages Low rates of hypoglycaemia Nausea mainly on initiation Weight loss in some patients Effective in controlling PPG

5 The Goals For T2D Management Today Include Optimal glucose control A1c, FPG, PPG Minimal hypoglycemia Weight loss or no weight gain

6 Exenatide Added to Insulin Glargine-Treated Patients with Type 2 Diabetes Richard M Bergenstal, MD; John B Buse, MD, PhD; Leonard C Glass, MD; Cory R Heilmann, PhD; Michelle S Lewis, PhD; Anita YM Kwan, MS; Byron J Hoogwerf, MD; Julio Rosenstock, MD

7 Primary Objective Study Objectives Exenatide BID plus optimized titration of basal insulin, glargine, (OG+EXE BID) is superior to placebo plus optimized titration of basal insulin, glargine, (OG+PLB BID) as measured by change in A1C from baseline to Week 3 Secondary Endpoints 7-Point self-monitored blood glucose (SMBG) profiles 1,5-Anhydroglucitol Change in body weight Change in insulin dose Self-reported hypoglycemic episodes and treatment-emergent adverse events (TEAEs)

8 Study Design Screening Randomization Study End 5μg EXE OG+EXE BID 1μg EXE Insulin Glargine + OAMs OG+PLB BID Weeks of treatment

9 Baseline Characteristics (ITT) EXE BID PLB BID N Female (n [%]) 67 (49) 44 (36) Age (y) 59 ± 9 59 ± 1 Weight (kg) 95.4 ± ± 21.2 BMI (kg/m 2 ) 33.8 ± ± 6.2 A1C (%) 8.32 ± ±.96 Diabetes duration (y) 12 ± 7 12 ± 7 FBG (mmol/l) 7.9 ± ± 2.3 Insulin Dose (U/kg).51 ±.28.5 ±.24 Systolic BP (mmhg) 13. ± ± 13.4 Diastolic BP (mmhg) 75.8 ± ± 8.7 OAMs (n [%]) None Metformin Pioglitazone Metformin+Pioglitazone 21 (15) 91 (66) 2 (2) 23 (17) 17 (14) 91 (75) 6 (5) 8 (7)

10 A1C Change from Baseline.5 OG+EXE BID (Baseline 8.3.1%) OG+PLB BID (Baseline 8.5.1%) A1C Change (%) Axis Title % 6.7.9% -2 LSMean ± SE 18 3 Weeks

11 LSMean ± SE *p<.1. p<.1 and **p<.5 for between-treatment comparison 7-point Glucose Profiles OG+EXE BID baseline OG+EXE BID endpoint OG+PLB BID baseline OG+PLB BID endpoint Glucose (mmol/l) ** * ** * * * *

12 Weight Change (kg) LSMean ± SE Change in Weight from Baseline 2 * * * * * *p<.1 between-treatment comparison OG+EXE BID (Baseline kg) OG+PLB BID (Baseline kg) * Weeks * * * *

13 Weight Change vs. A1C Change Weight Change (%) OG+EXE BID OG+PLB BID 31% 1% 64% 4% Weight Change (%) % 8% 41% 5% A1C Change (%) A1C Change (%) Values are for Week 3 completers

14 Change in Insulin Dose from Baseline Insulin Dose EXE BID PLB BID Baseline (U/day) Endpoint (U/day) Baseline (U/kg) Endpoint (U/kg) LSMean ± SE 49 ± 2 62 ± 2.51 ±.2.66 ±.2 47 ± 3 69 ± 2.51 ±.2.71 ±.2

15 Safety and Adverse Events EXE BID PLB BID Minor Hypoglycemia (n [%]) Overall incidence* 34 (25%) 35 (29%) Rate (episodes/patient/year)* Adverse Events (n [%]) Nausea 56 (41%) 1 (8%) Diarrhea 25 (18%) 1 (8%) Vomiting 25 (18%) 5 (4%) Headache 19 (14%) 5 (4%) Constipation 14 (1%) 2 (2%) One patient in the placebo arm had 2 episodes of major nocturnal hypoglycemia *No significant differences between groups p<.5, between-group comparison

16 Change in Blood Pressure and Heart Rate Systolic BP (mmhg) Endpoint Change EXE BID PLB BID P-value * ± ± ± ± Diastolic BP (mmhg) Endpoint Change 73.3 ± ± ± ±.7 <.1 Heart Rate (bpm) Endpoint Change 76.7 ± ± ± ±.8.8 Data presented as LSMean ± SE; * between-group comparison

17 Lixisenatide, a novel once-daily GLP-1 receptor agonist for the treatment of Type 2 diabetes: an ideal candidate for combination with basal insulin Riccardo Perfetti, MD, PhD Vice President, Global Medical Affairs Diabetes Division, Sanofi

18 Difference in PPG effect by GLP-1 analogues: lixisenatide versus liraglutide 1 Mean change from pre-meal plasma glucose (mg/dl) SEM Time after study drug administration (h) Test Test drug meal 4.5 LIXISENATIDE Day 1 Day 28 LIRAGLUTIDE Day 1 Day 28 Study PDY1931 compared the effects of lixisenatide versus liraglutide on PPG in 148 adults with T2DM insufficiently controlled (HbA 1c %) on 1.5 g/day of metformin 1 Greater reduction of PPG area under the curve with lixisenatide (129%) compared with liraglutide (41%) Overall incidence of AEs (mainly gastrointestinal [GI]) lower with lixisenatide (58%) versus liraglutide (73%) SEM=standard error of the mean; AE=adverse events 1. Kapitza et al. Abstract D-74; Presented at IDF 211, Dubai 26

19 Lixisenatide GetGoal clinical trial programme Study Objectives # of pts ClinicalTrials.gov Identifier GetGoal-Mono GetGoal-Mono Japan Efficacy and safety of monotherapy (1- or 2-step dose increase) Safety and efficacy of monotherapy in Asian patients (1- or 2-step dose increase) 361 NCT NCT95255 GetGoal-M Efficacy and safety in combination with MET 68 NCT GetGoal-M-Asia Efficacy and safety in combination with MET (+ SU) 391 NCT GetGoal-F1 Efficacy and safety in combination with MET (1 or 2-step dose increase) 482 NCT GetGoal-S Efficacy and safety in combination with SU (+ MET) 859 NCT71383 GetGoal-P Efficacy and safety in combination with pioglitazone (+ MET) 484 NCT GetGoal-X Efficacy and safety head-to-head vs exenatide (+ MET) 634 NCT7731 GetGoal-L Efficacy and safety in combination with basal insulin (+ MET) 496 NCT GetGoal-L Asia Efficacy and safety in combination with basal insulin (+ SU) 311 NCT GetGoal-Duo1 Efficacy and safety in combination with insulin glargine + MET (± TZDs) 446 NCT975286

20 GetGoal-L-Asia: study design Screening criteria: Asian patients with T2DM for 1 year on stable basal insulin with HbA 1c 7 1%, stratified by HbA 1c and SU use 15 µg 1 µg R n=311 1 µg 15 µg 2 µg 2 µg Placebo + basal insulin ±SU (n=157) Diet and lifestyle counselling every 3 months Lixisenatide + basal insulin ±SU (n=154) Screening Run-in Double-blind period of 24 weeks R=randomization; ClinicalTrials.gov identifier NCT Visit week Primary endpoint Seino et al. Diabetes Obes Metab 212 doi: /j x

21 GetGoal-L-Asia primary efficacy endpoint: change in HbA 1c from baseline to Week 24 Lixisenatide + basal insulin (n=146) Placebo + basal insulin (n=154) % Mean HbA 1c (%) ±SE % 7.6% LS mean change in HbA 1c (%) % 7. Baseline Week Week 24 LOCF* 1. p<.1 Week 24 LOCF* LS mean difference vs placebo:.9% (95% CI: 1.1 to.7) Modified intent-to-treat (mitt) population; *LOCF (on treatment value available) analysis for least squared mean or mean change at Week 24 Seino et al. Diabetes Obes Metab 212 doi: /j x

22 GetGoal-L-Asia: change in 2-hour PPG and glucose excursion at 24 weeks Lixisenatide + basal insulin (n=131) Placebo + basal insulin (n=142) 1 2-hour PPG* 1 Glucose excursion p<.1 p<.1 LS mean difference vs placebo: 7.8 mmol/l (95% CI: 8.9 to 6.8) LS mean difference vs placebo: 7.2 mmol/l (95% CI: 8.3 to 6.2) mitt population, LOCF (on treatment value available) analysis for least squared mean change at Week 24; *After a standardized breakfast meal test of Ensure Plus Drink (Abbot; contains 6 kilocalories with 54% carbohydrate, 17% protein and 29% fat); 2-hour PPG plasma glucose 3 minutes prior to meal test (before study drug administration) Seino et al. Diabetes Obes Metab 212 doi: /j x

23 GetGoal-L-Asia: change in body weight 24 Weeks Lixisenatide + basal insulin (n=15) Placebo + basal insulin (n=157).2 LS mean change (kg) p=.857 mitt population; LS Mean Change from baseline to Week 24 (LOCF) 1. Data on file 2. Seino et al. Diabetes Obes Metab 212 doi: /j x

24 GetGoal-L-Asia: adverse events over 24 weeks Adverse event, n (%) Lixisenatide + basal insulin (n=154) Placebo + basal insulin (n=157) Any TEAE 137 (89.) 11 (7.1) Serious TEAE 1 (6.5) 9 (5.7) TEAE leading to death 1 (.6) TEAE leading to discontinuation 14 (9.1) 5 (3.2) GI disorders (all) Nausea Vomiting Diarrhoea 94 (61.) 61 (39.6) 28 (18.2) 1 (6.5) 23 (14.6) 7 (4.5 ) 3 (1.9) 4 (2.5) Data are for the safety population (all patients who received 1 dose of study treatment); TEAE=treatment-emergent adverse event Seino et al. Diabetes Obes Metab 212 doi: /j x

25 GetGoal-L-Asia: symptomatic hypoglycaemia Lixisenatide + basal insulin (n=154) 91 Placebo + basal insulin (n=157) All patients Patients not receiving SU n=37 n=66 n=13 n=15 Data are for the safety population (all patients who received 1 dose of study treatment) No episodes of severe hypoglycaemia reported Seino et al. Diabetes Obes Metab 212 doi: /j x

26 GetGoal-L: study design 15 µg 2 µg Placebo + basal insulin ± metformin (n=167) Screening Criteria: T2DM for 1 year on stable basal insulin with HbA 1c 7 1%, stratified by HbA 1c (<8%/ 8%) and metformin use 1 µg R n=496 1 µg Diet and lifestyle counselling every 3 months 15 µg 2 µg Lixisenatide + basal insulin ± metformin (n=329) Screening Run-In Double-blind period of 24 weeks 3 1 ClinicalTrials.gov Identifer NCT Visit week (Phone call visit) 24 Primary endpoint Riddle et al. Abstract 983-P; Presented at ADA 212. Philadelphia, PA

27 GetGoal-L primary efficacy endpoint: change in HbA 1c from baseline to Week 24 Lixisenatide + basal insulin (n=34) Placebo + basal insulin (n=158) 8.6 Mean HbA 1c (%) ± SE % 7.8% LS mean change in HbA 1c (%) Week 24 Week LOCF*.8 p<.1 Week 24 LOCF* LS mean difference vs placebo:.4% (95% CI:.6 to.2) mitt population; *LOCF (on treatment value available) analysis for least squared mean or mean change at Week 24 Riddle et al. Abstract 983-P; Presented at ADA 212. Philadelphia, PA

28 GetGoal-L: change in 2-hour PPG and glucose excursion at 24 weeks Lixisenatide + basal insulin (n=235) Lixisenatide + basal insulin (n=233) Placebo + basal insulin (n=123) Placebo + basal insulin (n=123) 2-hour PPG* Glucose excursion p< p< LS mean difference vs placebo: 3.8 mmol/l (95% CI: 4.7 to 2.9) LS mean difference vs placebo: 3.8 mmol/l (95% CI: 4.6 to 3.) mitt population, LOCF (on treatment value available) analysis for least squared mean change at Week 24; *After a standardized breakfast meal test of Ensure Plus Drink (Abbot; contains 6 kilocalories with 54% carbohydrate, 17% protein and 29% fat); 2-hour PPG plasma glucose 3 minutes prior to meal test (before study drug administration) Riddle et al. Abstract 983-P; Presented at ADA 212. Philadelphia, PA

29 GetGoal-L: change in body weight at Week 24 Lixisenatide + basal insulin (n=311) Placebo + basal insulin (n=161) LS mean change (kg) p<.1 LS mean difference vs placebo: 1.3 kg (95% CI: 1.8 to.7) mitt population; LS Mean Change from baseline to Week 24 (LOCF) Riddle et al. Abstract 983-P; Presented at ADA 212. Philadelphia, PA

30 GetGoal-L: adverse events over 24 weeks Adverse event, n (%) Lixisenatide + basal insulin (n=328) Placebo + basal insulin (n=167) Any TEAE 241 (73.5) 114 (68.3) Any serious TEAE 12 (3.7) 7 (4.2) Death 1 (.3) TEAE leading to discontinuation Gastrointestinal disorders GI disorders (all) Nausea Vomiting Diarrhoea 25 (7.6) 14 (4.3) 132 (4.2) 86 (26.2) 27 (8.2) 24 (7.3) 8 (4.8) 2 (1.2) 34 (2.4) 14 (8.4) 1 (.6) 9 (5.4) Data are for the safety population (all patients who received 1 dose of study treatment) Riddle et al. Abstract 983-P; Presented at ADA 212. Philadelphia, PA

31 GetGoal-L: symptomatic hypoglycaemia over 24 weeks Type, n (%) Symptomatic hypoglycaemia Blood glucose <6 mg/dl Severe symptomatic hypoglycaemia Blood glucose <6 mg/dl Lixisenatide + basal insulin (n=328) 91 (27.7) 87 (26.5) 4 (1.2) 3 (.9) Placebo + basal insulin (n=167) 36 (21.6) 35 (21.) Data are for the safety population (all patients who received 1 dose of study treatment) Riddle et al. Abstract 983-P; Presented at ADA 212. Philadelphia, PA

32 GetGoal-Duo1: study design Lixisenatide titration Lixisenatide maintenance 2 Glargine + metformin + PLACEBO ± TZDs Screening Criteria: T2DM for 1 year MET 1.5 g/day ±TZDs ± SU or Glinide HbA 1c : 7.% and 1% N=147 Glargine + metformin (±TZDs) n=898 n=825 R n= (n=223) Randomized if criteria met: HbA 1C 7% and 9% Mean FPG 14 mg/dl* (7 days end of Run-in) Glargine + metformin + LIXISENATIDE ± TZDs (n=223) 2-week screening Glargine weekly titration; target FPG 8 1 mg/dl 12-week Run-In Glargine titrated to FPG target 8 1 mg/dl 24-week-double-blind period *This was changed from 126 mg/dl in July 21; ClinicalTrials.gov Identifer: NCT975286; MET=metformin Rosenstock et al. Abstract 62-OR; Presented at ADA 212, Philadelphia, PA

33 GetGoal-Duo1 primary efficacy endpoint: change in HbA 1c from baseline to Week 24 Lixisenatide + insulin glargine + metformin (n=215) Placebo + insulin glargine + metformin (n=221) Mean HbA 1c (%) ±SE Glargine + MET (±TZDs) Lixisenatide OR placebo + MET (±TZDs) SCR Week 7.3% 7.% Week 24 LOCF* LS mean change in HbA 1c (%) p<.1 Week 24 LOCF* LS mean difference vs placebo:.3% (95% CI:.5 to.2) mitt population; * LOCF (on treatment value available) analysis for least squared mean or mean change at Week 24; SCR=screening Rosenstock et al. Abstract 62-OR; Presented at ADA 212, Philadelphia, PA

34 GetGoal-Duo1: change in 2-hour PPG and glucose excursion at 24 weeks Lixisenatide + insulin glargine + metformin (n=194) Placebo + insulin glargine + metformin (n=24) 2-hour PPG* +.1 Glucose excursion LS mean change (mmol/l) LS mean change (mmol/l) p< LS mean difference vs placebo: 3.2 mmol/l (95% CI: 4. to 2.4) LS mean difference vs placebo: 3.1 mmol/l (95% CI: 3.8 to 2.3) mitt population, LOCF (on treatment value available) analysis for least squared mean change at Week 24; *After a standardized breakfast meal test of Ensure Plus Drink (Abbot; contains 6 kilocalories with 54% carbohydrate, 17% protein and 29% fat); 2-hour PPG plasma glucose 3 minutes prior to meal test (before study drug administration) Rosenstock et al. Abstract 62-OR; Presented at ADA 212, Philadelphia, PA

35 GetGoal-Duo1: change in body weight at Week 24 Lixisenatide + insulin glargine + metformin (n=217) Placebo + insulin glargine + metformin (n=22) 1.4 p=.12 LS mean change (kg) LS mean difference vs placebo:.9 kg (95% CI: 1.4 to.4) mitt population; LS Mean Change from baseline to Week 24 (LOCF) Rosenstock et al. Abstract 62-OR; Presented at ADA 212, Philadelphia, PA

36 GetGoal-Duo1: adverse events over 24 weeks Adverse event, n (%) Lixisenatide + insulin glargine + metformin (n=223) Placebo + insulin glargine + metformin (n=223) Any TEAE 178 (79.8) 152 (68.2) Serious TEAE 17 (7.6) 1 (4.5) TEAE leading to death 2 (.9) TEAE leading to discontinuation Nausea and vomiting GI disorders (all) Nausea Vomiting Diarrhoea Increases in pancreatic enzymes (lipase and/or amylase) or pancreatitis Pancreatitis 19 (8.5) 9 (4.) 89 (39.9) 61 (27.4) 21 (9.4) 15 (6.7) 5 (2.2) 8 (3.6) 36 (16.1) 11 (4.9) 3 (1.3) 7 (3.1) 1 (4.5) 1 (.4) Calcitonin increase ( 2 ng/l) during the on-treatment period 2 (.9) Injection site reactions 15 (6.7)* 5 (2.2) *Two patients (.9%) discontinued due to injection site reactions; Data are for the safety population (all patients who received 1 dose of study treatment) Rosenstock et al. Abstract 62-OR; Presented at ADA 212, Philadelphia, PA

37 GetGoal-Duo1: symptomatic hypoglycaemia over 24 weeks Type Blood glucose <6 mg/dl Lixisenatide + insulin glargine + metformin (n=223) Placebo + insulin glargine + metformin (n=223) Number of patients with events, n (%) 45 (2.2) 26 (11.7) Number of events/patient/year.8.44 Severe hypoglycaemia Number of patients with events, n (%) 1 (.4) Number of events 1 Data are for the safety population (all patients who received 1 dose of study treatment) Rosenstock et al. Abstract 62-OR; Presented at ADA 212, Philadelphia, PA

38 I ned to get these slides

39 n=498 61% n=162 43% of 39% n=987 n=161 17% of 39%

40

41 Glycemic efficacy, changes in body weight, and insulin detemir doses. DeVries J H et al. Dia Care 212;35: Copyright 211 American Diabetes Association, Inc.

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43 Conclusions: GLP-1 Agonists And Insulin Therapy Works Well Together And Makes Physiologic Sense Reduce A1c Improve fasting and postprandial glycemia Weight neurtral or weight loss Minimal hypoglycemia Thank You Very Much

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