Comparison of the Effect of Exenatide Versus Sitagliptin on 24-hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: exenatide; sitagliptin; placebo; placebo
Intervention description: subcutaneous injection (5mcg or 10mcg), twice a day; oral administration (100mg), once a day in the morning; subcutaneous injection (5mcg or 10mcg), twice a day; oral administration (100mg), once a day in the morning
Intervention MeSH terms: Sitagliptin Phosphate; Exenatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: diabetes; exenatide; sitagliptin; Amylin; Lilly; metformin; thiazolidinedione

Summary:

      This study is designed to compare the short-term effects and mechanisms of action of
      exenatide with those of sitagliptin when either is added to an oral agent(metformin or a
      thiazolidinedione [TZD]) in adult patients with type 2 diabetes mellitus(T2DM) with
      inadequate glycemic control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have type 2 diabetes

          -  Has HbA1c 7.0% to 11.0%, at or within 4 weeks prior to Visit 1.

          -  Have a fasting glucose concentration <280 mg/dL at Visit 1

          -  Have been treated with a stable dose of immediate or extended release metformin for at
             least 60 days prior to screening OR TZD (rosiglitazone or pioglitazone) for at least
             120 days prior to screening.

          -  Are between 18 and 70 years of age, inclusive.

          -  Have body mass index ≥25 kg/m2 and ≤45 kg/m2.

          -  Have a history of stable body weight (not varying by >10% for at least 3 months prior
             to screening).

          -  Can swallow oral study drug capsule, without splitting or crushing.

        Exclusion Criteria:

          -  Female patients of childbearing potential (not surgically sterilized and between
             menarche and 1 year postmenopause) who meet any of the following criteria:

               -  Are breastfeeding.

               -  Test positive for pregnancy at the time of screening.

               -  Intend to become pregnant during the study.

               -  Have not practiced a reliable method of birth control (for example, use of oral
                  contraceptives or Norplant®; diaphragms with contraceptive jelly; cervical caps
                  with contraceptive jelly; condoms with contraceptive foam; intrauterine devices;
                  partner with vasectomy; or abstinence) for 3 months prior to screening.

          -  Treated with any of the following medications:

               -  Insulin, exenatide, pramlintide, sulfonylureas or meglitinides within 3 months of
                  screening

               -  Alpha-glucosidase inhibitor within 2 months of screening.

               -  Drugs that directly affect gastrointestinal motility, including, but not limited
                  to metoclopramide, cisapride, and chronic macrolide antibiotics.

               -  Use of a drug for weight loss (for example, prescription drugs such as orlistat,
                  sibutramine, phentermine, or similar over-the-counter medications) within 3
                  months prior to Visit 1.

               -  Systemic corticosteroids by oral, intravenous, or intramuscular route within 2
                  months of screening.

          -  Have a history of renal transplantation or are currently receiving renal dialysis.

          -  Have obvious clinical signs or symptoms of liver disease or acute or chronic
             hepatitis.

          -  Have known active proliferative retinopathy or macular edema expected to need
             treatment with focal photocoagulation within 3 months.

          -  Have an 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 organ transplantation.

          -  Have received GLP-1 analogs other than exenatide or DPP-4 inhibitors within the
             previous 3 months.

          -  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.