Trials / Completed
CompletedNCT01169090
A Study Comparing the Safety, Tolerance, and Efficacy of Various Doses of SK-0403 Versus Placebo and Sitagliptin 100 mg in Patients Not Well-Controlled on Metformin Therapy
A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo Controlled Phase 2 Dose Finding Study Comparing the Safety, Tolerance, and Efficacy of Various Doses of SK-0403 Versus Placebo and Sitagliptin 100 mg in Patients Not Well-Controlled on Metformin Therapy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 620 (estimated)
- Sponsor
- Kowa Research Institute, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and efficacy of a range of doses of SK-0403 in subjects with type 2 diabetes that are not adequately controlled on metformin alone.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SK-0403 | SK-0403 |
| DRUG | Placebo | Placebo |
| DRUG | Sitagliptin | Sitagliptin |
Timeline
- Start date
- 2010-07-01
- Primary completion
- 2011-07-01
- Completion
- 2011-08-01
- First posted
- 2010-07-23
- Last updated
- 2011-08-17
Locations
40 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01169090. Inclusion in this directory is not an endorsement.