A Study to Assess the Effect of Exenatide Treatment on Mean 24-Hour Heart Rate in Patients With Type 2 Diabetes
- Registration Number
- NCT00516074
- Lead Sponsor
- AstraZeneca
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Arm placebo This arm will receive placebo injection (volume equivalent to the exenatide injection in the experimental arm). Exenatide Arm exenatide This arm will receive 5mcg exenatide for 4 weeks, and then 10mcg exenatide for the remaining 8 weeks of the study.
- Primary Outcome Measures
Name Time Method Change in Mean 24-hour Heart Rate From Baseline to Endpoint 12 weeks Change from baseline to endpoint in average heart rate measured over 24 hours by an ambulatory blood pressure monitor.
- Secondary Outcome Measures
Name Time Method Change in Nighttime (2400-0600) Heart Rate From Baseline to Endpoint 12 weeks Change from baseline to endpoint in nighttime (2400-0600) heart rate as measured by an ambulatory blood pressure monitor
Change in Mean 24 Hour Diastolic Blood Pressure From Baseline to Endpoint 12 weeks Change from baseline to endpoint in average diastolic blood pressure measured over 24 hours by an ambulatory blood pressure monitor
Change in Mean 24 Hour Systolic Blood Pressure From Baseline to Endpoint 12 weeks Change from baseline to endpoint in average systolic blood pressure measured over 24 hours by an ambulatory blood pressure monitor
Change in Daytime Heart Rate From Baseline to Endpoint 12 weeks Change from baseline to endpoint in daytime heart rate as measured by an ambulatory blood pressure monitor
Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint 12 weeks Change from baseline to endpoint in HbA1c
Trial Locations
- Locations (1)
Research Site
🇳🇱Utrecht, Netherlands