A Study to Assess the Effect of Exenatide Treatment on Mean 24-Hour Heart Rate in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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A Study to Assess the Effect of Exenatide Treatment on Mean 24-Hour Heart Rate in Patients With Type 2 Diabetes

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: exenatide
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exenatide Arm<br>This arm will receive 5mcg exenatide for 4 weeks, and then 10mcg exenatide for the remaining 8 weeks of the study. | Drug: exenatide<br>* subcutaneous injection, 5mcg or 10mcg, twice a day<br>* Other names: LY2148568;|
| Placebo Comparator: Placebo Arm<br>This arm will receive placebo injection (volume equivalent to the exenatide injection in the experimental arm). | Drug: placebo<br>* subcutaneous injection, volume equivalent to active, twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean 24-hour Heart Rate From Baseline to Endpoint | Change from baseline to endpoint in average heart rate measured over 24 hours by an ambulatory blood pressure monitor. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Daytime Heart Rate From Baseline to Endpoint | Change from baseline to endpoint in daytime heart rate as measured by an ambulatory blood pressure monitor | 12 weeks | 
| Change in Nighttime (2400-0600) Heart Rate From Baseline to Endpoint | Change from baseline to endpoint in nighttime (2400-0600) heart rate as measured by an ambulatory blood pressure monitor | 12 weeks | 
| Change in Mean 24 Hour Systolic Blood Pressure From Baseline to Endpoint | Change from baseline to endpoint in average systolic blood pressure measured over 24 hours by an ambulatory blood pressure monitor | 12 weeks | 
| Change in Mean 24 Hour Diastolic Blood Pressure From Baseline to Endpoint | Change from baseline to endpoint in average diastolic blood pressure measured over 24 hours by an ambulatory blood pressure monitor | 12 weeks | 
| Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint | Change from baseline to endpoint in HbA1c | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exenatide, Byetta, type 2 diabetes, heart rate, Amylin, Lilly