Status:
COMPLETED
Efficacy of Exenatide Once Weekly and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea (DURATION - 3)
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the effects of 2.0 mg exenatide once weekly and insulin glargine, titrated to glucose targets using the algorithm described by Yki- Järvinen et al.(2007), with ...
Eligibility Criteria
Inclusion
- Has type 2 diabetes and at least 18 years of age at screening.
- Hemoglobin A1c (HbA1c) of 7.1% to 11.0%, inclusive, at screening.
- Body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening.
- Have a history of stable body weight (not varying by \>5% for at least 3 months prior to screening).
- Have been treated with metformin(Met) for at least 3 months and have been taking a stable dose for at least 8 weeks prior to screening OR
- Have been treated with metformin(Met) for at least 3 months and have been taking a stable dose for at least 8 weeks prior to screening and have been treated with SU for at least 3 months and have been taking a stable dose of at least an optimally effective dose of brand of SU for 8 weeks prior to screening.
Exclusion
- Have had a clinically significant 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; or is expected to require coronary artery bypass surgery or angioplasty during the course of the study.
- Have clinical signs or symptoms of liver disease, acute or chronic hepatitis.
- 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 had greater than three episodes of major hypoglycemia within 6 months prior to screening.
- Have any contraindication for the oral antidiabetic agent which they use.
- Have a known allergy or hypersensitivity to insulin glargine, exenatide once weekly, or excipients contained in these agents.
- Are known to 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 for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening:
- Insulin
- Thiazolidinediones (e.g., Actos® \[pioglitazone\] or Avandia® \[rosiglitazone\])
- Alpha-glucosidase inhibitors (e.g., Glyset® \[miglitol\] or Precose® \[acarbose\])
- Meglitinides (e.g., Prandin® \[repaglinide\] or Starlix® \[nateglinide\]).
- Byetta® (exenatide BID formulation)
- Dipeptidyl peptidase (DPP)-4 inhibitors (e.g., Januvia™ \[sitagliptin\], Galvus® \[vildagliptin\])
- Symlin® (pramlintide acetate).
- Have had an organ transplant.
- Have donated blood within 30 days of screening.
- Have previously completed or 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 :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
467 Patients enrolled
Trial Details
Trial ID
NCT00641056
Start Date
April 1 2008
End Date
November 1 2009
Last Update
June 15 2015
Active Locations (75)
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1
Research Site
Escondido, California, United States
2
Research Site
Jacksonville, Florida, United States
3
Research Site
Orlando, Florida, United States
4
Research Site
West Palm Beach, Florida, United States