NCT02647320

12-Week Study of DS-8500a in Subjects With Type 2 Diabetes Mellitus on Metformin

A Randomized, Double-Blind, Placebo-Controlled With Active Comparator, 12-Week Study of DS-8500a in Subjects With Type 2 Diabetes Mellitus on Metformin

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 298 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The hypothesis of this Phase 2, 12-week study, is that DS-8500a will improve glycemic control relative to placebo, based on changes in HbA1c, with acceptable safety and tolerability, in patients with Type 2 Diabetes Mellitus (T2DM) who are treated with metformin.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Sitagliptin 100 mg	Two sitagliptin 50 mg tablets, over-encapsulated to provide a once-daily dose of 100 mg, for oral administration
DRUG	DS-8500a 25mg	DS-8500a 25mg tablet for oral administration
DRUG	Placebo Tablet	Placebo matching DS-8500a tablet for oral administration
DRUG	Placebo Capsule	Placebo matching sitagliptin over-capsule for oral administration

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-01-31
• Completion: 2017-01-31
• First posted: 2016-01-06
• Last updated: 2019-02-25
• Results posted: 2018-05-01

Locations

58 sites across 2 countries: United States, Canada