Trials / Terminated
TerminatedNCT00850239
Safety and Efficacy Study of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 700 (estimated)
- Sponsor
- Phenomix · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to demonstrate the efficacy of dutogliptin over 26 weeks (as evidenced by placebo-corrected changes in HbA1c relative to baseline), to demonstrate safety and tolerability of dutogliptin, and to demonstrate changes in fasting plasma glucose over 26 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | dutogliptin | 400 mg |
| DRUG | placebo |
Timeline
- Start date
- 2009-05-01
- Primary completion
- 2010-10-01
- Completion
- 2010-12-01
- First posted
- 2009-02-24
- Last updated
- 2010-08-11
Locations
97 sites across 7 countries: United States, Argentina, Chile, Czechia, India, Peru, Poland
Source: ClinicalTrials.gov record NCT00850239. Inclusion in this directory is not an endorsement.