NCT00947557

Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus (T2DM) on Background Therapy With Glimepiride With or Without Metformin

A Phase III, Randomized, Double-Blind, Placebo-controlled, Multicenter Study To Evaluate The Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus on Background Treatment With Glimepiride With or Without Metformin

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 677 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM) who are receiving background therapy of glimepiride with or without metformin.

Conditions

• Diabetes Mellitus, Type II

Interventions

Type	Name	Description
DRUG	Dutogliptin	Dutogliptin oral administration once daily on background of glimepiride with or without metformin
DRUG	Placebo	Placebo, oral administration once daily on background of glimepiride with or without metformin

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-07-01
• First posted: 2009-07-28
• Last updated: 2011-09-21

Locations

147 sites across 8 countries: United States, Belarus, Colombia, Hungary, India, Lithuania, Peru, Romania