Status:
COMPLETED
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)
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 p...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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- Have previously completed or discontinued study drug in this study, withdrawn from this study or any other study investigating exenatide once weekly.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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
820 Patients enrolled
Trial Details
Trial ID
NCT00676338
Start Date
November 1 2008
End Date
January 1 2011
Last Update
April 9 2015
Active Locations (106)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Buena Park, California, United States
2
Research Site
Los Angeles, California, United States
3
Research Site
Valencia, California, United States
4
Research Site
Jacksonville, Florida, United States