A Study of ASP1941 in Participants With Type 2 Diabetes Mellitus

Summary

The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of ASP1941 in male and female patients with type 2 diabetes mellitus

Timeline

Start

2008-03-26

Primary completion

2009-03-14

Completion

2009-03-14

Outcome

Met primary endpoint

paper All ipragliflozin-treated groups had clinically significant, dose-dependent decreases in glycated hemoglobin (HbA1c) and fasting plasma glucose levels compared with placebo-treated groups. PMID 25411597 ↗

paper were -0.61%, -0.97%, -1.29%, and -1.31%, respectively (P < 0.001). PMID 25411597 ↗

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.
• Kashiwagi A, Kazuta K, Yoshida S, Nagase I. Randomized, placebo-controlled, double-blind glycemic control trial of novel sodium-dependent glucose cotransporter 2 inhibitor ipragliflozin in Japanese patients with type 2 diabetes mellitus. J Diabetes Investig. 2014 Jul;5(4):382-91. doi: 10.1111/jdi.12156. Epub 2013 Nov 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ipragliflozin	Small molecule	12.5 mg	Oral
Subject	ipragliflozin	Small molecule	25 mg	Oral
Subject	ipragliflozin	Small molecule	50 mg	Oral
Subject	ipragliflozin	Small molecule	100 mg	Oral

Indications