A phase 3 randomized placebo-controlled trial to assess the efficacy and safety of ipragliflozin as an add-on therapy to metformin in Russian patients with inadequately controlled type 2 diabetes mellitus. (December 2018)

• Record Type: Journal Article
• Authors: Shestakova, Marina V.; Wilding, John P.H.; Wilpshaar, Wim; Tretter, Reiner; Orlova, Valeria L.; Verbovoy, Andrey F.
• Is Part Of: Diabetes research and clinical practice. Volume 146(2018)
• Page Start: 240
• Page End: 250
• Publication Date: 2018-12
• Subjects: Diabetes mellitus, type 2 -- Ipragliflozin -- Metformin -- Randomized controlled trial -- Sodium-glucose co-transporter-2 (SGLT2) inhibitor; Diabetes -- Periodicals; Diabetes Mellitus -- Periodicals; 616.462
• DOI: 10.1016/j.diabres.2018.10.018
• Languages: English
• ISSNs: 0168-8227

Abstract

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 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.