NCT02628392

A Phase 2 Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)

A Phase 2, Randomized, Double-blind, Dose Finding Study of DS-8500a in Japanese Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 368 (actual)
• Sponsor: Daiichi Sankyo Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The objectives of the study is to evaluate the efficacy, safety, and dose of DS-8500a compared with placebo in patients with type 2 diabetes mellitus.

Detailed description

The objectives of the study is to evaluate the efficacy, safety, and dose of DS-8500a compared with placebo in patients with type 2 diabetes mellitus after a 12-week oral administration of DS-8500a at 25, 50, or 75 mg in a double-blind, parallel-group comparison study. In addition, the clinical positioning of DS-8500a relative to an existing drug will be investigated using sitagliptin as a comparator.

Conditions

• Type2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	DS-8500a	DS-8500a tablets 25mg, 50mg, 75mg
DRUG	Sitagliptin	capsules
DRUG	placebo	matching DS-8500a tablets and sitagliptin capsules

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2015-12-11
• Last updated: 2019-02-12

Locations

1 site across 1 country: Japan