A Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus (DURATION-5)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: exenatide once weekly; exenatide twice daily
Intervention description: subcutaneous injection, 2.0mg, once a week; subcutaneous injection; 5mcg (4 weeks) and 10mcg (20 weeks); twice a day
Intervention MeSH terms: Exenatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 254.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: diabetes; exenatide once weekly; Byetta; Amylin; Lilly; Bydureon

Summary:

      This study will compare the effects of commercially manufactured exenatide once weekly and
      exenatide BID in subjects whose type 2 diabetes is managed with diet and exercise alone or
      with oral antidiabetic medications. The study will examine glycemic control (as measured by
      HbA1C), safety, and tolerability.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has been diagnosed with type 2 diabetes mellitus

          -  Has hemoglobin-specific A1c fraction (HbA1c) of 7.1% to 11.0%, inclusive, at screening

          -  Has a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening

          -  Has been treated with diet and exercise alone or in combination with a stable regimen
             of metformin (MET), a sulfonylurea (SU), a thiazolidinedione (TZD), a combination of
             metformin and an SU, a combination of metformin and a TZD, or a combination of an SU
             and a TZD for a minimum of 2 months prior to screening

          -  Either is not treated with or has been on a stable treatment regimen with any of the
             following medications for a minimum of 2 months prior to screening:

               -  Hormone replacement therapy (female subjects)

               -  Oral contraceptives (female subjects)

               -  Antihypertensive agents

               -  Lipid-lowering agents

               -  Thyroid replacement therapy

               -  Antidepressant agents

               -  Drugs known to affect body weight, including prescription medications (e.g.
                  orlistat [XENICAL®], sibutramine [MERIDIA®], topiramate [TOPAMAX®]) and over the
                  counter antiobesity agents

        Exclusion Criteria:

          -  Has ever been exposed to exenatide (exenatide once weekly [exenatide LAR], exenatide
             BID, BYETTA, or any other formulation) or any glucagon-like peptide-1 (GLP-1) analog

          -  Has received any investigational drug within one month (or five half-lives of the
             investigational drug, whichever is greater) of screening

          -  Has been treated, is currently being treated, or is expected to require or undergo
             treatment with any of the following treatment excluded medications:

               -  Any dipeptidyl peptidase 4 (DPP-4) inhibitor within 3 months prior to screening

               -  Alpha glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®)
                  within 30 days of screening

               -  Insulin within 2 weeks of screening or for more than 1 week within 3 months of
                  screening

               -  Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent,
                  inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate
                  of systemic absorption