Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control, as measured by hemoglobin A1c (HbA1c), in patients with type 2 diabetes who experience inadequate glycemic control with OAD alone.

Key facts

Study ID

NCT00099320

Run by

AstraZeneca

People needed

182

Starts

2004-05-01

Expected to finish

2005-08-01

Last updated by the study team

2015-02-23

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Treated with thiazolidinedione (TZD) alone or in combination with metformin. TZD dose stable for at least 120 days prior to screening, and those patients on metformin must have been on a stable dose for at least 30 days prior to screening.
• HbA1c between 7.1% and 10.0%, inclusive.
• Body mass index (BMI) between 25 kg/m\^2 and 45 kg/m\^2.

You may not qualify if…

• Patient previously in a study using exenatide or GLP-1 analogs.
• Treated with oral anti-diabetic medications other than TZD and metformin within 3 months of screening.
• Treated with oral insulin within 3 months of screening.

Where it is running

• Research Site — La Jolla, California, United States
• Research Site — San Mateo, California, United States
• Research Site — Santa Barbara, California, United States
• Research Site — Spring Valley, California, United States
• Research Site — Hialeah, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Melbourne, Florida, United States
• Research Site — West Palm Beach, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Honolulu, Hawaii, United States
• Research Site — Idaho Falls, Idaho, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Baton Rouge, Louisiana, United States
• Research Site — Kalamazoo, Michigan, United States
• Research Site — Troy, Michigan, United States
• Research Site — Butte, Montana, United States
• Research Site — McCook, Nebraska, United States
• Research Site — North Platte, Nebraska, United States
• Research Site — Omaha, Nebraska, United States
• Research Site — Scottsbluff, Nebraska, United States
• Research Site — Princeton, New Jersey, United States
• Research Site — Albuquerque, New Mexico, United States
• Research Site — Albany, New York, United States
• Research Site — New York, New York, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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