A Study to Assess the Efficacy and Safety of Ipragliflozin in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin

Phase 3 Completed 268 enrolled Astellas Pharma Europe B.V.

RandomizedParallel-groupTriple-blindTreatment

Summary

The main purpose of this study is to evaluate the efficacy in reducing glycated hemoglobin of ipragliflozin in combination with metformin compared with metformin plus placebo in subjects with type 2 diabetes mellitus who have inadequate glycemic control on metformin.

Timeline

Start: 2016-05-11
Primary completion: 2017-03-02
Completion: 2017-06-20

Publications

Kashiwagi A, Shestakova MV, Ito Y, Noguchi M, Wilpshaar W, Yoshida S, Wilding JPH. Safety of Ipragliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Phase II/III/IV Clinical Trials. Diabetes Ther. 2019 Dec;10(6):2201-2217. doi: 10.1007/s13300-019-00699-8. Epub 2019 Oct 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ipragliflozin	Small molecule	—	Oral
Background	Metformin	Small molecule	—	Oral

A Study to Assess the Efficacy and Safety of Ipragliflozin in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin

Summary

Timeline

Publications

Drugs

Indications