NCT00998686

Safety and Efficacy Study of Dutogliptin in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin

A Phase 3, Randomized, Double-Blind, Active-Controlled, Multi-Center Extension Study to Evaluate Safety and Efficacy of Dutogliptin in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 650 (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 safety and tolerability of dutogliptin over 52 weeks.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	dutogliptin	400 mg
DRUG	sitagliptin	100 mg

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-10-01
• Completion: 2011-11-01
• First posted: 2009-10-20
• Last updated: 2010-08-11

Locations

44 sites across 6 countries: United States, Argentina, Czechia, India, Peru, Poland