NCT01089790

Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus Receiving Background Treatment With Glimepiride Alone or in Combination With Metformin or With Pioglitazone Alone

A Phase III, Multicenter, Double-blind, Active-Controlled, 52 Week Extension Study to Evaluate the Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus Receiving Background Treatment With Glimepiride Alone or in Combination With Metformin or With Pioglitazone Alone

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years – 86 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the long-term safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM).

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Dutogliptin	400 mg tablet, once daily
DRUG	Sitagliptin	100 mg capsule (each capsule contains two 50-mg tablets), once daily

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-08-01
• First posted: 2010-03-19
• Last updated: 2011-09-21

Locations

149 sites across 1 country: United States