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

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

This study will assess safety and efficacy of exenatide in combination with a thiazolidinedione (TZD) and a TZD plus metformin over 26 weeks in adult patients with type 2 diabetes who have not achieved adequate glycemic control.

Key facts

Study ID: NCT00603239
Run by: AstraZeneca
People needed: 165
Starts: 2008-01-01
Expected to finish: 2009-07-01
Last updated by the study team: 2015-04-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Diagnosed with type 2 diabetes
If treated with a thiazolidinedione (TZD) alone, the TZD dose must have been stable for at least 120 days
The dose of TZD must be: Rosiglitazone (≥4 mg/day) or pioglitazone (≥30 mg/day)
The metformin dose has been stable for at least 90 days
Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 10.0%, inclusive.
Have a body mass index (BMI): 25 kg/m2 < BMI < 45 kg/m2.

You may not qualify if…

Have participated in this study previously or any other study using exenatide (AC2993/LY2148568) or glucagon-like peptide-1 (GLP-1) analogs, or have been previously treated with exenatide or GLP-1 analogs
Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry.
Have been treated with exogenous insulin for more than 1 week within the 2 months prior to screening
Used drugs for weight loss (e.g., orlistat, rimonabant, sibutramine, or similar over-the-counter medications) within 3 months prior to screening.
Are currently treated with any of the following excluded medications:
Sulfonylurea or meglitinide derivatives (e.g., repaglinide or nateglinide) within 3 months prior to screening
Alpha-glucosidase inhibitor (e.g., miglitol or acarbose) within 3 months of screening
Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g., sitagliptin or vildagliptin) within 3 months prior to screening
Pramlintide acetate injection within 3 months prior to screening
Drugs that directly affect gastrointestinal motility, including, but not limited to: Metoclopramide, cisapride, and chronic macrolide antibiotics
Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding study start

Where it is running

Research Site — Birmingham, Alabama, United States
Research Site — Concord, California, United States
Research Site — Fresno, California, United States
Research Site — Denver, Colorado, United States
Research Site — Las Vegas, Nevada, United States
Research Site — Mogadore, Ohio, United States
Research Site — Corvallis, Oregon, United States
Research Site — New Westminster, British Columbia, Canada
Research Site — Winnipeg, Manitoba, Canada
Research Site — Ajax, Ontario, Canada
Research Site — Cambridge, Ontario, Canada
Research Site — Windsor, Ontario, Canada
Research Site — Chihuahua City, Chihuahua, Mexico
Research Site — Celaya, Guanajuato, Mexico
Research Site — Mexico City, Mexico City, Mexico
Research Site — Monterrey, Nuevo León, Mexico
Research Site — Mexico City, Mexico
Research Site — Baia Mare, Romania
Research Site — Brasov, Romania
Research Site — Bucharest, Romania
Research Site — Dolj, Romania
Research Site — Iași, Romania
Research Site — Suceava, Romania
Research Site — Johannesburg, South Africa
Research Site — Pretoria, South Africa

Full record on ClinicalTrials.gov

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