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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type II

In brief

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.

Key facts

Study ID

NCT00947557

Run by

Forest Laboratories

People needed

677

Starts

2009-07-01

Last updated by the study team

2011-09-21

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 2 diabetes mellitus, diagnosed at least 3 months prior to Screening (Visit 1)
• BMI 20 to 48 kg/m2, inclusive
• HbA1c 7.0% - 10.0%, inclusive
• Age 18 to 85 years, inclusive

You may not qualify if…

• Currently on 3 or more oral antidiabetic drugs or insulin.
• Type 1 diabetes mellitus

Where it is running

• 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 — Litchfield, Arizona, United States
• Forest Investigative Site 080 — Peoria, Arizona, United States
• Forest Investigative Site 098 — Phoenix, Arizona, United States
• Forest Investigative Site 044 — Scottsdale, Arizona, United States
• Forest Investigative Site 061 — Anaheim, California, United States
• Forest Investigative Site 041 — Chula Vista, California, United States
• Forest Investigative Site 049 — Encinitas, California, United States
• Forest Investigative Site 022 — Greenbrae, California, United States
• Forest Investigative Site 047 — Harbor City, California, United States
• Forest Investigative Site 010 — Huntington Park, California, United States
• Forest Investigative Site 070 — Los Angeles, California, United States
• Forest Investigative Site 111 — Northridge, California, United States
• Forest Investigative Site 031 — Riverside, California, United States
• Forest Investigative Site 091 — Roseville, California, United States
• Forest Investigative Site 067 — Sacramento, California, United States
• Forest Investigative Site 112 — Santa Ana, California, United States
• Forest Investigative Site 011 — Walnut Creek, California, United States
• Forest Investigative Site 063 — West Hills, California, United States
• Forest Investigative Site 088 — Denver, Colorado, United States
• Forest Investigative Site 156 — Boca Raton, Florida, United States
• Forest Investigative Site 064 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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