Marina V Shestakova1, John P H Wilding2, Wim Wilpshaar3, Reiner Tretter3, Valeria L Orlova4, Andrey F Verbovoy5. 1. Endocrinology Research Centre, Diabetes Institute, Moscow, Russia. Electronic address: shestakova.mv@gmail.com. 2. Obesity and Endocrinology Research, Institute of Ageing and Chronic Disease, Clinical Sciences Centre, University of Liverpool, Liverpool, United Kingdom. 3. Astellas Pharma Europe B.V., Leiden, Netherlands. 4. Autonomous Noncommercial Organization "Medical Centre "XXI century", St. Petersburg, Russia. 5. Diabetes Center, Samara, Russia.
Abstract
AIM: To assess the efficacy and safety of ipragliflozin as add-on therapy to metformin in Russian patients with type 2 diabetes mellitus. METHODS: In this double-blind study conducted in 14 centers in Russia, 165 patients were randomized 2:1 to ipragliflozin (50 mg/day) or placebo for 24 weeks while continuing metformin. Patients who had HbA1c ≥ 7.0% (53 mmol/mol) at Week 12 receivedopen-label ipragliflozin (50 mg/day) in addition to the blinded drug from Week 12-24. RESULTS: Significant reductions in HbA1c and body weight from baseline to Week 12 in favor of ipragliflozin were observed (adjusted mean difference to placebo: -0.3% (-3 mmol/mol), P = 0.048 and -1.34 kg, P < 0.001, respectively). The incidence of AEs was similar in both groups. Uptitration to 100 mg/day ipragliflozin led to a further reduction in body weight (mean change from Week 12: -0.65 kg, P = 0.004) and an additional 13% (9/69) of patients achieving HbA1c < 7.0% (53 mmol/mol) at Week 24. Incidence of AEs was similar among patients receiving ipragliflozin 50 mg/day (23.7%) and 100 mg/day (24.6%). CONCLUSION:Ipragliflozin 50 mg/day added to metformin significantly reduced HbA1c and body weight after 12 weeks and showed a safety profile comparable to placebo. Uptitration to 100 mg/day improved clinical outcomes with no additional safety concerns.
RCT Entities:
AIM: To assess the efficacy and safety of ipragliflozin as add-on therapy to metformin in Russian patients with type 2 diabetes mellitus. METHODS: In this double-blind study conducted in 14 centers in Russia, 165 patients were randomized 2:1 to ipragliflozin (50 mg/day) or placebo for 24 weeks while continuing metformin. Patients who had HbA1c ≥ 7.0% (53 mmol/mol) at Week 12 received open-label ipragliflozin (50 mg/day) in addition to the blinded drug from Week 12-24. RESULTS: Significant reductions in HbA1c and body weight from baseline to Week 12 in favor of ipragliflozin were observed (adjusted mean difference to placebo: -0.3% (-3 mmol/mol), P = 0.048 and -1.34 kg, P < 0.001, respectively). The incidence of AEs was similar in both groups. Uptitration to 100 mg/day ipragliflozin led to a further reduction in body weight (mean change from Week 12: -0.65 kg, P = 0.004) and an additional 13% (9/69) of patients achieving HbA1c < 7.0% (53 mmol/mol) at Week 24. Incidence of AEs was similar among patients receiving ipragliflozin 50 mg/day (23.7%) and 100 mg/day (24.6%). CONCLUSION:Ipragliflozin 50 mg/day added to metformin significantly reduced HbA1c and body weight after 12 weeks and showed a safety profile comparable to placebo. Uptitration to 100 mg/day improved clinical outcomes with no additional safety concerns.
Authors: Sanaz Kamalinia; Robert G Josse; Patrick J Donio; Lindsay Leduc; Baiju R Shah; Sheldon W Tobe Journal: Endocrinol Diabetes Metab Date: 2019-11-13