Trials / Completed
CompletedNCT00036192
Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea
A Randomized, Double-Blind, Placebo-Controlled Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (planned)
- Sponsor
- Astellas Pharma Inc · Industry
- Sex
- All
- Age
- 25 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to assess the safety and efficacy of FK614 in type 2 diabetic subjects receiving sulfonylurea (SU) monotherapy.
Detailed description
This is a prospective randomized, double-blind, placebo controlled, parallel group, Phase 2 study. Subjects meeting selection criteria will be randomly assigned to receive 12 weeks twice daily (BID) dosing with FK614 or placebo. Enrollment for this study will be approximately 200 patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FK614 |
Timeline
- Start date
- 2002-02-01
- Completion
- 2006-03-01
- First posted
- 2002-05-09
- Last updated
- 2011-12-09
Locations
36 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00036192. Inclusion in this directory is not an endorsement.