A Study to Assess the Effect of Exenatide Treatment on Mean 24-Hour Heart Rate in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: exenatide; placebo
Intervention description: subcutaneous injection, 5mcg or 10mcg, twice a day; subcutaneous injection, volume equivalent to active, 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: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: exenatide; Byetta; type 2 diabetes; heart rate; Amylin; Lilly

Summary:

      This study will explore the effect of exenatide (given twice a day) versus placebo (given
      twice a day) treatment on change in mean 24-hour heart rate over a 12 week period of drug
      exposure in patients with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with type 2 diabetes.

          -  Treated with metformin and/or a thiazolidinedione.

          -  HbA1c between 6.5% and 9.5%, inclusive.

          -  Body Mass Index (BMI) > 25 kg/m^2 and < 40 kg/m^2.

        Exclusion Criteria:

          -  Have previously received exenatide or glucagon-like peptide-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.

          -  Receiving beta blockers.

          -  Receiving treatment with a drug directly affecting gastrointestinal motility,
             including but not limited to Reglan® (metoclopramide), Propulsid® (cisapride), and
             chronic macrolide antibiotics.

          -  Have received treatment with systemic glucocorticoid therapy by oral, intravenous
             (IV), or intramuscular (IM) route within 6 weeks of screening, or are regularly
             treated with potent, inhaled intranasal steroids that are known to have a high rate of
             systemic absorption or bronchodilators.

          -  Have been treated with drugs that promote weight loss (for example, Adipex®
             [phentermine], Acomplia® [rimonabant], Xenical® [orlistat], Meridia® [sibutramine],
             Acutrim® [phenylpropanolamine], or similar over-the-counter medications) within 3
             months of screening.

          -  Have been treated for longer than 2 weeks with any of the following excluded
             medications within 3 months prior to screening: *Insulin; *Alpha-glucosidase
             inhibitors (for example, Glyset® [miglitol] or Precose® [acarbose]); *Meglitinides
             (for example, Prandin® [repaglinide] or Starlix® [nateglinide]); *Sulfonylureas (for
             example, Glucotrol® [glipizide] or Micronase® [glyburide]); *Dipeptidyl peptidase IV
             (DPP-IV) inhibitors (for example, Januvia™ [sitagliptin])

          -  Have donated blood within 60 days of screening.