Trials / Completed
CompletedNCT02685345
A Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus Receiving Sitagliptin
A Phase 2, Randomized, Double-blind, Placebo-controlled, add-on Study of DS-8500a in Japanese Patients With Type 2 Diabetes Mellitus Receiving Sitagliptin
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 85 (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 and safety of DS-8500a compared with placebo in patients with type 2 diabetes mellitus (T2DM) receiving sitagliptin.
Detailed description
In patients with type 2 diabetes mellitus being treated with sitagliptin, efficacy and safety of DS-8500a are to be evaluated after 28-day multiple oral administration of DS-8500a at 25 or 75 mg, in a double-blind, placebo-controlled, parallel-group comparison study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DS-8500a 25 mg | |
| DRUG | DS-8500a 75 mg | |
| DRUG | placebo |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2016-09-01
- Completion
- 2016-10-01
- First posted
- 2016-02-18
- Last updated
- 2019-02-12
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT02685345. Inclusion in this directory is not an endorsement.