This is a multicenter study designed to compare the effect of exenatide plus a lifestyle modification plan versus placebo plus a lifestyle modification plan on weight loss in non-diabetic, obese subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
163
Research Site
Peoria, Arizona, United States
Research Site
Tucson, Arizona, United States
Research Site
Santa Ana, California, United States
Change in Body Weight
Change in body weight from baseline after 24 weeks of treatment (i.e., body weight at week 24 minus body weight at week 0)
Time frame: 24 weeks
Change in Body Mass Index (BMI)
Change in BMI from baseline after 24 weeks of treatment (i.e., BMI at week 24 minus BMI at week 0)
Time frame: 24 weeks
Change in Waist-to-hip Ratio
Waist-to-hip ratio at week 24 compared to waist-to-hip ratio at week 0 (i.e., waist-to-hip ratio at week 24 minus waist-to-hip ratio at week 0). Waist-to-hip ratio equals waist circumference at given time point divided by hip circumference at given timepoint.
Time frame: 24 weeks
Percentage of Patients Experiencing >=5% Weight Loss
Percentage of exenatide and placebo treated patients experiencing \>=5% weight loss after 24 weeks of treatment (i.e., \[weight at week 0 minus weight at week 24\] divided by weight at week 0 times 100% \>=5%)
Time frame: 24 weeks
Change in Total Cholesterol
Change in total cholesterol from baseline after 24 weeks of treatment (i.e., total cholesterol at week 24 minus total cholesterol at week 0)
Time frame: 24 weeks
Change in High Density Lipoprotein (HDL) Cholesterol
Change in HDL cholesterol from baseline after 24 weeks of treatment (i.e., HDL cholesterol at week 24 minus HDL cholesterol at week 0)
Time frame: 24 weeks
Ratio of Endpoint (LOCF) to Baseline for Fasting Triglycerides (Logarithmically Transformed)
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Research Site
Indianapolis, Indiana, United States
Research Site
Topeka, Kansas, United States
Research Site
Wichita, Kansas, United States
Research Site
Baton Rouge, Louisiana, United States
Research Site
St Louis, Missouri, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Goose Creek, South Carolina, United States
...and 6 more locations
Ratio of triglycerides at week 24 compared to triglycerides at week 0 (i.e., triglycerides at week 24 divided by triglycerides at week 0)
Time frame: 24 weeks
Change in Low Density Lipoprotein (LDL) Cholesterol
Change in LDL cholesterol from baseline following 24 weeks of treatment (i.e., LDL cholesterol at week 24 minus LDL cholesterol at week 0)
Time frame: 24 weeks
Change in Fasting Serum Glucose
Change in fasting serum glucose from baseline following 24 weeks of treatment (i.e., fasting serum glucose at week 24 minus fasting serum glucose at week 0)
Time frame: 24 weeks
Change in Serum Glucose AUC Levels Following Oral Glucose Tolerance Test (OGTT)
Change in serum glucose AUC following OGTT (week 24 compared to week 0) (i.e., serum glucose AUC at week 24 minus serum glucose AUC at week 0)
Time frame: 24 weeks
Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Beta Cell (HOMA-B) (Logarithmically Transformed)
Ratio of HOMA-B at week 24 to HOMA-B at week 0 (i.e., HOMA-B at week 24 divided by HOMA-B at week 0). HOMA-B is a measure of beta cell function.
Time frame: 24 weeks
Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) (Logarithmically Transformed)
Ratio of HOMA-S at week 24 to HOMA-S at week 0 (i.e., HOMA-S at week 24 divided by HOMA-S at week 0). HOMA-S is a measure of insulin sensitivity.
Time frame: 24 weeks
Incidence of Patients That Demonstrate Overt Signs of Diabetes Mellitus Diagnosis
Number of patients in each treatment group that demonstrate overt signs of diabetes mellitus diagnosis by week 24
Time frame: 24 weeks
Incidence of Patients That Demonstrate Normalization of Impaired Fasting Glucose (IFG) and/or Impaired Glucose Tolerance (IGT)
Number of patients in each treatment group that demonstrate normalization of IFG and/or IGT by week 24
Time frame: 24 weeks
Change in High Sensitivity C-reactive Protein (hsCRP)
Change in hsCRP levels from baseline following 24 weeks of treatment (i.e., hsCRP at week 24 minus hsCRP at week 0)
Time frame: 24 weeks
Change in Glycosylated Hemoglobin (HbA1c)
Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)
Time frame: 24 weeks