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



Shestakova, Marina V, Wilding, John PH ORCID: 0000-0003-2839-8404, Wilpshaar, Wim, Tretter, Reiner, Orlova, Valeria L and Verbovoy, Andrey F
(2018) 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. DIABETES RESEARCH AND CLINICAL PRACTICE, 146. pp. 240-250.

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Abstract

<h4>Aim</h4>To assess the efficacy and safety of ipragliflozin as add-on therapy to metformin in Russian patients with type 2 diabetes mellitus.<h4>Methods</h4>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.<h4>Results</h4>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%).<h4>Conclusion</h4>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.

Item Type: Article
Uncontrolled Keywords: Diabetes mellitus, type 2, Ipragliflozin, Metformin, Randomized controlled trial, Sodium-glucose co-transporter-2 (SGLT2) inhibitor
Depositing User: Symplectic Admin
Date Deposited: 08 Nov 2018 15:03
Last Modified: 19 Jan 2023 01:13
DOI: 10.1016/j.diabres.2018.10.018
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3028584