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)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: exenatide once weekly; metformin; sitagliptin; pioglitazone
Intervention description: subcutaneous injection, 2mg, once weekly plus placebo oral once daily; oral, 1000-2500mg, daily plus placebo once weekly subcutaneous injection; oral, 100 mg, daily plus placebo once weekly subcutaneous injection; oral, 30-45mg, daily plus placebo once weekly subcutaneous injection
Intervention MeSH terms: Metformin; Pioglitazone; Sitagliptin Phosphate; Exenatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 820.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Amylin; Lilly; exenatide once weekly; Byetta; Januvia; sitagliptin; thiazolidinedione

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 patients with type 2 diabetes treated with diet and exercise.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.