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

Phase 3

Terminated

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: sitagliptin; Drug: dutogliptin

• Registration Number: NCT00998686
• Lead Sponsor: Phenomix

Brief Summary

The purpose of this study is to demonstrate the safety and tolerability of dutogliptin over 52 weeks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-16
• Study First Submitted QC: 2009-10-19
• Study First Posted: 2009-10-20
• Study Start: 2009-11
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-10
• Last Update Posted: 2010-08-11
• Primary Completion: 2011-10
• Study Completion: 2011-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

• Completion of all required visits of a qualifying Phase 3 core protocol
• Current treatment of Type 2 diabetes mellitus as in PHX1149-PROT302

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
sitagliptin	sitagliptin	-
dutogliptin/PHX1149T	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 (43)

Phenomix Investigational Site 105; 🇺🇸 Anaheim, California, United States

Phenomix Investigational Site 121; 🇺🇸 Tempe, Arizona, United States

Phenomix Investigational Site 137; 🇺🇸 Tempe, Arizona, United States

Phenomix Investigational Site 103; 🇺🇸 Long Beach, California, United States

Phenomix Investigational Site 106; 🇺🇸 Los Angeles, California, United States

Phenomix Investigational Site 143; 🇺🇸 Coral Gables, Florida, United States

Phenomix Investigational Site 142; 🇺🇸 Hialeah, Florida, United States

Phenomix Investigational Site 133; 🇺🇸 Kissimmee, Florida, United States

Phenomix Investigational Site 101; 🇺🇸 Honolulu, Hawaii, United States

Phenomix Investigational Site 135; 🇺🇸 Chicago, Illinois, United States

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