NOUVELLLES THERAPIES EN DIABÈTE
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1 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 Obésité Métabolisme et Diabète, IRCM Service d endocrinologie du CHUM Cardio-Metabolic Summit Montréal Octobre 2013
2 Objectifs 2 Quel est l effet des inhibiteurs des SGLT-2 dans le tubule rénal? Quels sont les effets cliniques de l inhibition SGLT2? Quels sont les effets secondaires de l inhibition SGLT2?
3 ORGANES CIBLES DES THÉRAPIES ORALES Metformin Thiazolidinediones α-glucosidase inhibitors Reduce Hyperglycemia SGLT2 inhibitors? GLP-1 analogues DPP-4 inhibitors GLP, glucagon-like peptide; DPP, didpeptidyl peptidase Sulfonylureas Glitinides
4 SGLT2 est le principal transporteur de glucose Bowman s capsule Filtration occurs in Bowman s capsule: 180 L/day Filtered glucose S1 segment Glucose is reabsorbed in the proximal convoluted tubule 90% of glucose reabsorption S3 segment 10% of glucose reabsorption No glucose
5 Inhibiteurs de SGLT2 Cana, dapa, empglifozin Bowman s capsule Filtration occurs in Bowman s capsule: 180 L/day Filtered glucose S1 segment Glucose is reabsorbed in the proximal convoluted tubule 90% of glucose reabsorption S3 segment 10% of glucose reabsorption Glucose
6 Variation de l HbA1C avec le Dapagliflozin Études de 24 semaines BL (%) Mono- Add-on to therapy MET (N=558) (N=546) Add-on to SU (N=596) Add-on to PIO (N=420) Add-on to Insulin (N=807) 8.53 Δ HbA1c (%) with 95% CI *Statistically significant vs. placebo using Dunnett s correction Adjusted mean change from baseline using ANCOVA, excluding data after rescue (LOCF) FDA Advisory Committee 19 th July 2011:
7 Variation de l HbA1C avec le Canagliflozin Études de 26 semaines Placebo-controlled Phase 3 Studies BL Mean HbA (%) 1c Add-on Combinations with Metformi SU Met/SU Met/Pio n (DIA3008) (DIA3002) (DIA3012) (DIA3006) N = 127 N = 469 N = 342 N = Monotherapy (DIA3005) N =584 Insulin (DIA3008) N = 1718 Current Therapy in Older Subjects (DIA3010) N = Placebo-subtracted LS Mean Change in HbA 1c (%) (95% CI) All at 26 weeks except 18 weeks DIA3008 Insulin, SU substudies * p<0.001 Based on ANCOVA models, data prior to rescue (LOCF) CANA 100 mg CANA 300 mg CC-39 /EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM pdf. Accessed January 23, 2013
8 Variation de l HbA1c (52 sem.) Dapagliflozin vs. SU en addition au Metformin N BL Mean (%) Adjusted % of patients with 1 episode of hypoglycaemia # p<0.0001** Percent with 95% CI difference 0.00 (95% CI 0.11 to 0.11) Titration period Maintenance period Dapa + MET Glipizide + MET Adjusted mean change from baseline using ANCOVA (LOCF) N s at Week 52 equal N s at baseline Non-inferior compared to limit of 0.35% Nauck M, et al. Diabetes Care 34: , 2011 # Adjusted percent using modified logistic regression analysis: ** Statistically significant by heirarchical testing rule.
9 Effet du Dapagliflozin (10 mg) sur le poids dans les études de phase 3 (Baseline values) 24 wk Add-on to Add-on Monotherapy 1 Metformin 2 to SU 3 (94.2 kg) (86.3 kg) (80.6 kg) Add-on to Insulin (24 wks) 4 (94.6 kg) Add-on to Insulin (48 wks) 5 (94.6 kg) H2H DAPA +MET H2H GLIP +MET Adjusted mean change from baseline in Body Weight (kg) *p<0.0001; ^Difference 4.7 kg 95% CI: 5.1 to 4.2 p< Ferrannini E et al., Diabetes Care. 2010;33: Bailey CJ et al., Lancet. 2010;375: Strojek K et al., Diabetes Obes Metab. 2011;13: Wilding J et al., Diabetes 2010;59 (Suppl I): A78. 5.Wilding J et al., EASD 2010 Scientific Sessions, Stockholm, Sweden, Abstract 871.
10 Canagliflozin: Effets sur le poids te la composition corporelle en ajout au Metformin comparativement au Glimepiride LS Mean % Change from Baseline ± SE Body Weight Weight Loss Over Time BL Mean Body Weight (kg): 86.6 N =1450 Week BL %* (-4.4 kg) -5.7%* (-4.7 kg) Change in Body Composition (DXA Analysis Subgroup) N=312 Glimepiride Lean Mass CANA 100 mg Fat Mass CANA 300 mg Glimepiride CANA 100 mg * p <0.001 Based on ANCOVA model, data prior to rescue (LOCF) CANA 300 mg Weight changes relative to glimepiride in DXA analysis subgroup (-5.3 kg and -5.0 kg for CANA 100 mg and 300 mg, respectively) were similar to overall cohort. CC-10 /EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM pdf. Accessed January 23, 2013
11 Effet du Dapagliflozin (10 mg) sur la pression artérielle dans les études de phase 3 Systolic BP (mm Hg) 24 Wk Monotherapy 1 Add-on to Metformin 2 Add-on to SU 3 Diastolic BP (mm Hg) 24 wk Add-on to Monotherapy1 Metformin 2 Add-on to SU 3 Adjusted mean change from baseline (mm Hg) Statistical significance not reported Studies examining effects of SGLT 2 inhibitors on BP underway 1. Ferrannini E et al., Diabetes Care. 2010;33: Bailey CJ et al., Lancet. 2010;375: Strojek K et al., Diabetes Obes Metab. 2011;13: Dapagliflozin not FDA approved
12 Infections urinaires et génitales (Dapagliflozin) Vulvovaginitis and other related infections Urinary Tract Infections % of Patients Women PBO 2.5 mg 5 mg 10 mg n=677 n=400 n=581 n=598 FDA Advisory Committee 19 th July 2011: Statistical significance not reported Dapagliflozin not FDA approved
13 Canagliflozin: Effets sur le profile lipidique Études vs placebo LS Mean placebo-subtracted absolute change from baseline at Week 26 LS Mean Absolute Change from Baseline (mg/dl) (95% CI) Increases in Apo B and NMR measured LDL particle number approximately half as large as increases in LDL-C BL Mean Value LDL-C mg/dl Non-HDL-C mg/dl HDL-C 45.9 mg/dl LDL-C/HDL- C 2.4 Triglycerides mg/dl CC /EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM pdf. Accessed January 23, 2013
14 All Phase 2b and 3 Pool, All Cases as of May 2011 Possible risque carcinologique (Dapagliflozin) Tumor Origin N = Overall Malignancies and Unspecified Tumors All Dapa 4559 Events Control 2239 Difference from Control Dapa better Control better Bladder * (Updated) 7 (9) 0 (1) Thyroid and Endocrine Gastrointestinal Pancreatic Hepatobiliary Musculoskeletal and Soft Tissue Metastases and Site Unspecified Blood and Lymphatic Skin Renal Tract Respiratory and Mediastinal Gender-specific tumor types: Breast (Female) Prostate (Male) Female Reproductive (Female) FDA Advisory Committee 19 th July 2011: Dapagliflozin not FDA approved
15 Canagliflozin: données CV préliminaires (évènements adjudiqués) Toutes les études de phase II et III Non-CANA All CANA Hazard Ratio Events/PYs (per 100 patientyrs) Events/PYs (per 100 patientyrs) Primary Endpoint 71/3467 (2.05) 130/6821 (1.91) Favors CANA Favors Non-CANA Estimate (95% CI) 0.91 (0.68, 1.22) CV Endpoint CV Death 16/3496 (0.46) 21/6888 (0.30) 0.65 (0.34, 1.24) FNF MI 27/3484 (0.78) 45/6864 (0.66) 0.83 (0.52, 1.34) FNF Stroke 16/3489 (0.46) 47/6859 (0.69) 1.47 (0.83, 2.59) Unstable angina 18/3484 (0.52) 26/6874 (0.38) 0.71 (0.39, 1.30) Hazard Ratio CC-15 /EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM pdf. Accessed January 23, 2013
16 Inhibiteurs des SGLT2 : résumé Glucosurie réduction de l HbA1c, (G à J & PP) Efficace Monotherapie En combinaison avec les autres agents oraux & l insuline Réduction du poids et de la pression artérielle Efficacité maintenue au long cours Risque accru d infections urinaires et génitales Sécurité au long cours a établir
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