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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Research Site
Temple, Arizona, United States
Research Site
Colorado Springs, Colorado, United States
Research Site
Honolulu, Hawaii, United States
Percentage Change in Abdominal Visceral Fat From Baseline to 6 Months
Percentage change in abdominal visceral fat
Time frame: baseline, 6 months
Percentage Change in Total Abdominal Fat From Baseline to 6 Months
Percentage change in total abdominal fat
Time frame: baseline, 6 months
Percentage Change in Subcutaneous Abdominal Fat From Baseline to 6 Months
Percentage change in subcutaneous abdominal fat
Time frame: baseline, 6 months
Change in HbA1c From Baseline to 6 Months
Change in HbA1c from baseline to 6 months. HbA1c is a measurement of the amount of hemogobin that is glycosylated.
Time frame: baseline, 6 months
Percentage of Patients With HbA1c <=7.0% at 6 Months
Percentage of patients with HbA1c values \<= 7.0% measured at 6 months. HbA1c is a measurement of the amount of hemogobin that is glycosylated.
Time frame: 6 months
Change in Fasting Plasma Glucose From Baseline to 6 Months
Change in Fasting plasma glucose
Time frame: baseline, 6 months
Change in Weight From Baseline to 6 Months
Change in weight
Time frame: baseline, 6 months
Change in Systolic Blood Pressure From Baseline to 6 Months
Change in Systolic blood pressure
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Research Site
Bellevue, Nebraska, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Calgary, Alberta, Canada
Research Site
Vancouver, British Columbia, Canada
Research Site
Victoria, British Columbia, Canada
Research Site
Winnipeg, Manitoba, Canada
Research Site
Saint John, New Brunswick, Canada
...and 7 more locations
Time frame: baseline, 6 months
Change in Diastolic Blood Pressure From Baseline to 6 Months
Change in Diastolic blood pressure
Time frame: baseline, 6 months
Change in Total Cholesterol From Baseline to 6 Months
Change in total cholesterol
Time frame: baseline, 6 months
Change in Triglycerides From Baseline to 6 Months
Change in triglycerides
Time frame: baseline, 6 months
Change in High-Density Lipoprotein (HDL) Cholesterol From Baseline to 6 Months
Change in HDL cholesterol
Time frame: baseline, 6 months
Assessment of Event Rate of Treatment- Emergent Hypoglycemic Event
All hypoglycemia episodes defined as major (results in loss of consciousness, seizure or coma resolving after administration of glucagon or glucose OR needing third-party assistance to resolve due to severe impairment in consciousness and associated with glucose concentration \< 2.8 mol/L.) or minor (non-major event with symptoms consistent with hypoglycemia and glucose value \< 2.8 mmol/L prior to treating) or symptoms of hypoglycemia (does not meet the criteria for a major or minor event).
Time frame: baseline, 6 months