Effect of Exenatide on Abdominal Fat Distribution in Patients With Type 2 Diabetes Pretreated With Metformin
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Intervention: placebo; exenatide
Intervention description: subcutaneous injection, twice a day; subcutaneous injection, twice a day, 10mcg
Intervention MeSH terms: Exenatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: diabetes mellitus; Amylin; Lilly

Summary:

      A multicenter, randomized, double-blind, placebo-controlled trial will assess the effects of
      twice-daily subcutaneous injection with exenatide versus treatment with matching placebo
      injection on abdominal visceral fat content.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients between 18 and 85 years of age, inclusive.

          -  Patients with type 2 diabetes

          -  Patients have been treated with metformin, at a stable dose for at least 3 months
             prior to Visit 1

          -  Patients have HbA1c of 7.0% to 8.9%, inclusive.

          -  Patients have a body mass index >27 kg/m2 and <40 kg/m2 and meet local CT scan body
             weight requirements. For South Asian, Japanese, and Chinese patients, a body mass
             index >=25 kg/m2 is acceptable as the lower limit.

          -  Patients have a history of stable body weight (not varying by >2 kg in the 3 months
             prior to Visit 1).

          -  Medications for the treatment of high blood pressure are stable with respect to
             treatment regimen for 4 weeks prior to Visit 1.

          -  Stable regimen of lipid-lowering agents for 6 weeks prior to Visit 1.

        Exclusion Criteria:

          -  Have received treatment in the last 30 days with a drug that has not received
             regulatory approval for any indication at the time of study entry.

          -  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 a history of renal transplantation, or are currently receiving renal dialysis.

          -  Have had a clinically significant history of cardiac disease or presence of active
             cardiac disease within 1 year prior to Visit 1, including myocardial infarction,
             clinically significant arrhythmia, unstable angina, moderate to severe congestive
             heart failure, coronary artery bypass surgery, or angioplasty; or is expected to
             require coronary artery bypass surgery or angioplasty during the course of the study.

          -  Have known hemoglobinopathy or clinically significant, chronic anemia.

          -  Known or are likely to become transfusion dependent during the study.

          -  Have active, symptomatic proliferative retinopathy.

          -  Are receiving chronic treatment for gastrointestinal disease with a drug directly
             affecting gastrointestinal motility. (i.e. metoclopramide, cisapride, and chronic use
             of macrolide antibiotics)

          -  Have severe gastrointestinal disease, including gastroparesis.

          -  Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy
             (excluding topical and inhaled preparations) or have received such therapy within 2
             months immediately prior to Visit 1.

          -  Have taken exenatide, liraglutide or any other GLP-1 receptor agonist in the past 6
             months, either in a clinical study or as commercially available medication. Patients
             with known allergy to exenatide should be excluded.

          -  Have used any prescription or over the counter drug to promote weight loss within 3
             months prior to Visit 1, or intend to use such a drug during the study. (Examples:
             Xenical [orlistat], Meridia [sibutramine], Acutrim [phenylpropanolamine], Acomplia
             [rimonabant]).

          -  Have participated in a structured weight loss program within 3 months prior to Visit
             1, or intend to participate in such a plan during this study.

          -  Have been treated for longer than 2 weeks with any of the following excluded
             medications within 3 months prior to Visit 1: Insulin; Thiazolidinediones;
             Alpha-glucosidase inhibitors; Sulfonylureas; Oral DPP-IV inhibitors; Meglitinides.

          -  Are taking warfarin, or a coumarol derivative.