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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
54
Research Site
Halifax, Nova Scotia, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Etten-Leur, Netherlands
Research Site
Leiden, Netherlands
Research Site
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.
Time frame: 12 weeks
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 weeks
Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint
Change from baseline to endpoint in HbA1c
Time frame: 12 weeks
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Rotterdam, Netherlands
Research Site
Utrecht, Netherlands