Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes (DURATION-4)

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

This study will compare the effects of 2.0 mg exenatide once weekly injection as monotherapy to 3 active comparators(metformin, dipeptidyl peptidase-4 inhibitor, and thiazolidinedione) in drug naive patients with type 2 diabetes treated with diet and exercise.

Key facts

Study ID: NCT00676338
Run by: AstraZeneca
People needed: 820
Starts: 2008-11-01
Expected to finish: 2011-01-01
Last updated by the study team: 2015-04-09

Who can join

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

You may qualify if…

have type 2 diabetes and are treated with diet and exercise alone.
at least 18 years of age.
HbA1c between 7.1% and 11.0%, inclusive.
Body mass index (BMI) of 23 kg/m2 to 45 kg/m2, inclusive.
Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).

You may not qualify if…

Have history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty
Have a history of renal transplantation or are currently receiving renal dialysis
Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
Have history of severe GI disorder (e.g., gastroparesis)
Have a history of acute or chronic pancreatitis.
Have active proliferative retinopathy.
Have been treated with drugs that promote weight loss (e.g., Xenical®[orlistat], Meridia® [sibutramine], Acomplia® [rimonabant], Acutrim® [phenylpropanolamine], or similar over-the-counter medications) within 3 months of screening.
Have been treated with any antidiabetic agent for more than 7 days within 3 months prior to screening.
Have had an organ transplant.
Have previously completed or discontinued study drug in this study, withdrawn from this study or any other study investigating exenatide once weekly.
Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Are currently enrolled in any other clinical study.

Where it is running

Research Site — Los Angeles, California, United States
Research Site — Valencia, California, United States
Research Site — Jacksonville, Florida, United States
Research Site — Atlanta, Georgia, United States
Research Site — Meridian, Idaho, United States
Research Site — Des Moines, Iowa, United States
Research Site — Grand Rapids, Michigan, United States
Research Site — Minneapolis, Minnesota, United States
Research Site — Billings, Montana, United States
Research Site — Toms River, New Jersey, United States
Research Site — Wilmington, North Carolina, United States
Research Site — Danville, Pennsylvania, United States
Research Site — Philadelphia, Pennsylvania, United States
Research Site — Wilke Barre, Pennsylvania, United States
Research Site — Austin, Texas, United States
Research Site — El Paso, Texas, United States
Research Site — New Branufels, Texas, United States
Research Site — Buenos Aires, Argentina
Research Site — Mar del Plata, Argentina
Research Site — Leuven, Belgium
Research Site — Marchovelette, Belgium
Research Site — Tessenderlo, Belgium
Research Site — Brasília, Brazil
Research Site — Campinas, Brazil
Research Site — Buena Park, California, United States

Full record on ClinicalTrials.gov

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