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)

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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 respect to glycemic improvements, body weight, fasting lipids, safety, and tolerability.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Eli Lilly and Company
• Treatments: Exenatide; Insulin; Insulin Glargine; Insulin, Globin Zinc; Metformin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.