NCT02222350

Phase 2 Study of DS-8500a in Patients With Type 2 Diabetes

A Phase 2, Placebo-controlled, Double-blind Study of DS-8500a in Patients With Type 2 Diabetes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Daiichi Sankyo Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the efficacy and safety of DS-8500a compared with placebo in Japanese patients with Type 2 Diabetes Mellitus.

Detailed description

The objective of this study is to evaluate the efficacy and safety of DS-8500a 10 mg and 75 mg administered orally, once daily, for 28 days, compared with placebo, in Japanese patients with Type 2 Diabetes Mellitus in a double-blind, placebo-controlled parallel-group design. The primary endpoint is the change in 24-hour weighted mean glucose at day 28 from baseline. The safety, pharmacokinetics, and pharmacodynamics of DS-8500a will be evaluated as well.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	10mg DS-8500a tablet
DRUG	75mg DS-8500a tablet
DRUG	placebo

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-11-01
• Completion: 2015-01-01
• First posted: 2014-08-21
• Last updated: 2019-02-12

Locations

1 site across 1 country: Japan