Clinical trial NCT00637273 (phase 3, status: completed)
Conditions: type 2 diabetes mellitus
ICD codes: E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: exenatide once weekly, sitagliptin, pioglitazone, placebo tablet, placebo once weekly
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O, N[C@@H](CC(=O)N1CCN2C(C1)=NN=C2C(F)(F)F)CC1=CC(F)=C(F)C=C1F, N[C@@H](CCCNC(N)=N)C(O)=O, CC1=CC(O)=CC(C)=C1Cl, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Has been diagnosed with type 2 diabetes mellitus

          -  Has a hemoglobin-specific A1c fraction (HbA1c) of 7.1% to 11.0%, inclusive, at study
             start

          -  Has a body mass index (BMI)of 25 kg/m2 to 45 kg/m2, inclusive, at study start

          -  Has been on a stable treatment regimen of metformin for a minimum of 2 months prior to
             study start

          -  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 study start:

               1. Hormone replacement therapy (female subjects)

               2. Oral contraceptives (female subjects)

               3. Antihypertensive agents

               4. Lipid-lowering agents

               5. Thyroid replacement therapy

               6. Antidepressant agents

               7. 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 been previously exposed to exenatide once weekly

          -  Has donated blood within 60 days of study start or is planning to donate blood during
             the study

          -  Currently being treated, or is expected to require or undergo treatment with any of
             the following treatment-excluded medications:

               1. Exenatide (BYETTA®) or any Dipeptidyl peptidase-4 DPP-4)inhibitor, sulfonylurea
                  (SU), thiazolidinedione (TZD), or glucagon-like peptide (GLP)-1 analog within 3
                  months prior to study start

               2. Alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®)
                  within 30 days of study start

               3. Insulin within 2 weeks of study start or for more than 1 week within 3 months of
                  study start

               4. 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

               5. Drugs interacting with the CYP2C8 enzyme system, including gemfibrozil (LOPID®)
                  and rifampin

          -  Has received any investigational drug within 1 month (or five half-lives of
             investigational drug, whichever is greater) of study start

          -  Has previously experienced a clinically significant adverse event (e.g., significant
             edema) related to TZD or DPP-4 inhibitor use