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)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Exenatide Once Weekly; Insulin Glargine
Intervention description: subcutaneous injection, 2.0mcg, once weekly; subcutaneous injection, variable dose, QD
Intervention MeSH terms: Insulin Glargine; Exenatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 467.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: diabetes; exenatide; exenatide once weekly; metformin; sulfonylurea; insulin glargine; Amylin; Lilly

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.
    

Eligibility 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.