Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using a Thiazolidinedione or a Thiazolidinedione and Metformin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: exenatide; placebo
Intervention description: subcutaneous injection, 5 mcg or 10 mcg, twice a day (BID); subcutaneous injection, volume equivalent to 5 mcg or 10 mcg of active drug, twice a day
Intervention MeSH terms: Exenatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 165.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: diabetes; exenatide; metformin; thiazolidinedione; Byetta; Amylin; Lilly

Summary:

      This study will assess safety and efficacy of exenatide in combination with a
      thiazolidinedione (TZD) and a TZD plus metformin over 26 weeks in adult patients with type 2
      diabetes who have not achieved adequate glycemic control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with type 2 diabetes

          -  If treated with a thiazolidinedione (TZD) alone, the TZD dose must have been stable
             for at least 120 days

          -  The dose of TZD must be: Rosiglitazone (≥4 mg/day) or pioglitazone (≥30 mg/day)

          -  The metformin dose has been stable for at least 90 days

          -  Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 10.0%,
             inclusive.

          -  Have a body mass index (BMI): 25 kg/m2 < BMI < 45 kg/m2.

        Exclusion Criteria:

          -  Have participated in this study previously or any other study using exenatide
             (AC2993/LY2148568) or glucagon-like peptide-1 (GLP-1) analogs, or have been previously
             treated with exenatide or GLP-1 analogs

          -  Have participated in an interventional medical, surgical, or pharmaceutical study (a
             study in which an experimental, drug, medical, or surgical treatment was given) within
             30 days of screening. This criterion includes drugs that have not received regulatory
             approval for any indication at the time of study entry.

          -  Have been treated with exogenous insulin for more than 1 week within the 2 months
             prior to screening

          -  Used drugs for weight loss (e.g., orlistat, rimonabant, sibutramine, or similar
             over-the-counter medications) within 3 months prior to screening.

          -  Are currently treated with any of the following excluded medications:

               -  Sulfonylurea or meglitinide derivatives (e.g., repaglinide or nateglinide) within
                  3 months prior to screening

               -  Alpha-glucosidase inhibitor (e.g., miglitol or acarbose) within 3 months of
                  screening

               -  Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g., sitagliptin or vildagliptin)
                  within 3 months prior to screening

               -  Pramlintide acetate injection within 3 months prior to screening

               -  Drugs that directly affect gastrointestinal motility, including, but not limited
                  to: Metoclopramide, cisapride, and chronic macrolide antibiotics

               -  Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid
                  therapy (excluding topical and inhaled preparations) or have received such
                  therapy within the 4 weeks immediately preceding study start