Double-blind Ipragliflozin Add-on Study in Japanese Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sitagliptin (MK-0431J-843)

Phase 3 Completed 143 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a study to assess the safety and efficacy of the addition of ipragliflozin once daily in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on sitagliptin, diet, and exercise therapy. The primary hypothesis for this study is that the addition of ipragliflozin compared with placebo provides greater reduction in hemoglobin A1C (HbA1c) as assessed by change from baseline at Week 24.

Timeline

Start: 2015-11-09
Primary completion: 2016-11-25
Completion: 2016-11-25

Outcome

Met primary endpoint

registry LEAST_SQUARES_MEAN Ipragliflozin + Sitagliptin: -0.84 (-0.99 to -0.69) Percent NCT02577003 ↗

registry analysis (superiority test); Ipragliflozin + Sitagliptin vs Placebo + Sitagliptin; p <0.001; Difference in least squares means -0.77 (95% CI -0.98 to -0.57); NCT02577003 ↗

Publications

Kaku K, Kadowaki T, Seino Y, Okamoto T, Shirakawa M, Sato A, O'Neill EA, Engel SS, Kaufman KD. Efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes and inadequate glycaemic control on sitagliptin. Diabetes Obes Metab. 2021 Sep;23(9):2099-2108. doi: 10.1111/dom.14448. Epub 2021 Jun 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ipragliflozin	Small molecule	50 mg	Oral
Background	Sitagliptin	Small molecule	50 mg	Oral