Trials / Completed
CompletedNCT02669732
An Exploratory Study of DS-8500a on Beta Cell Function Using Hyperglycemic Clamp
A Phase 2, Randomized, Placebo-controlled, Double-blind, Crossover Study of DS-8500a to Evaluate the Effects on Pancreatic Beta Cell Function in Japanese Patients With Type 2 Diabetes Mellitus.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Daiichi Sankyo Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The objective of the study is to evaluate change in insulin secretory capacity in patients with type 2 diabetes mellitus as determined by hyperglycemic clamp after a 28-day oral administration of DS-8500a at 75 mg in a placebo-controlled, 2 × 2 crossover study. In addition, safety of this regimen will be examined in this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DS-8500a | tablets |
| DRUG | placebo | tablets |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2016-08-01
- Completion
- 2016-10-01
- First posted
- 2016-02-01
- Last updated
- 2019-02-12
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT02669732. Inclusion in this directory is not an endorsement.