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

Phase 3

Terminated

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Sitagliptin; Drug: Dutogliptin

• Registration Number: NCT01089790
• Lead Sponsor: Forest Laboratories

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-17
• Study First Submitted QC: 2010-03-18
• Study First Posted: 2010-03-19
• Primary Completion: 2010-08
• Status Verified: 2011-09
• Disposition First Submitted: 2011-09-14
• Disposition First Submitted QC: 2011-09-14
• Last Update Submitted: 2011-09-14
• Disposition First Posted: 2011-09-21
• Last Update Posted: 2011-09-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 141

Inclusion Criteria

• Have successfully completed all required visits of a qualifying Phase 3 core protocol
• Be currently receiving treatment for T2DM as set forth in the qualifying Phase 3 core protocol

Exclusion Criteria

• Any condition, disease, disorder or clinically relevant laboratory abnormality which, in the opinion of the investigator, would jeopardize the patient's appropriate participation in this study or obscure the effects of treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Sitagliptin	-
1	Dutogliptin	-

Primary Outcome Measures

Name	Time	Method
To demonstrate safety and tolerability of dutogliptin as assessed by vital signs, adverse event reporting, routine clinical laboratory assessments, and ECG	52 weeks

Secondary Outcome Measures

Name	Time	Method
To demonstrate maintenance or lowering of HbA1c and fasting plasma glucose.	52 weeks

Trial Locations

Locations (149)

Forest Investigative Site 064; 🇺🇸 Birmingham, Alabama, United States

Forest Investigative Site 020; 🇺🇸 Birmingham, Alabama, United States

Forest Investigative Site 025; 🇺🇸 Muscle Shoals, Alabama, United States

Forest Investigative Site 059; 🇺🇸 Chandler, Arizona, United States

Forest Investigative Site 113; 🇺🇸 Gilbert, Arizona, United States

Forest Investigative Site 096; 🇺🇸 Goodyear, Arizona, United States

Forest Investigative Site 080; 🇺🇸 Peoria, Arizona, United States

Forest Investigative Site 098; 🇺🇸 Phoenix, Arizona, United States

Forest Investigative Site 133; 🇺🇸 Phoenix, Arizona, United States

Forest Investigative Site 044; 🇺🇸 Scottsdale, Arizona, United States

Scroll for more (139 remaining)