This study will compare the effects of 2.0 mg exenatide once weekly injection as monotherapy to 3 active comparators(metformin, dipeptidyl peptidase-4 inhibitor, and thiazolidinedione) in drug naive patients with type 2 diabetes treated with diet and exercise.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
820
subcutaneous injection, 2mg, once weekly plus placebo oral once daily
oral, 1000-2500mg, daily plus placebo once weekly subcutaneous injection
oral, 100 mg, daily plus placebo once weekly subcutaneous injection
Change in HbA1c From Baseline to Week 26
Change in HbA1c from baseline to Week 26.
Time frame: Baseline, Week 26
Percentage of Patients Achieving HbA1c <=7% at Week 26
Percentage of patients achieving HbA1c \<=7% at Week 26 (for patients with baseline HbA1c \>7%).
Time frame: Baseline, Week 26
Change in Fasting Serum Glucose (FSG) From Baseline to Week 26
Change in FSG from baseline to Week 26.
Time frame: Baseline, Week 26
Change in Body Weight From Baseline to Week 26
Change in Body Weight from baseline to Week 26.
Time frame: Baseline, Week 26
Change in Fasting Total Cholesterol (TC) From Baseline to Week 26
Change in Fasting TC from baseline to Week 26.
Time frame: Baseline, Week 26
Change in Fasting High-Density Lipoprotein (HDL) From Baseline to Week 26
Change in Fasting HDL from baseline to Week 26.
Time frame: Baseline, Week 26
Ratio of Fasting Triglycerides at Week 26 to Baseline
Ratio of Fasting Triglycerides (measured in mmol/L) at Week 26 to baseline. Log(Post-baseline Triglycerides) - log(Baseline Triglycerides); change from baseline to Week 26 is presented as ratio of endpoint to baseline.
Time frame: Baseline, Week 26
Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events
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oral, 30-45mg, daily plus placebo once weekly subcutaneous injection
Research Site
Buena Park, California, United States
Research Site
Los Angeles, California, United States
Research Site
Valencia, California, United States
Research Site
Jacksonville, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Meridian, Idaho, United States
Research Site
Des Moines, Iowa, United States
Research Site
Grand Rapids, Michigan, United States
Research Site
Minneapolis, Minnesota, United States
Research Site
Billings, Montana, United States
...and 96 more locations
Major hypoglycemia is defined as any event that has symptoms consistent with hypoglycemia resulting in loss of consciousness or seizure that shows prompt recovery in response to administration of glucagon or glucose, or documented hypoglycemia (blood glucose \<3.0 mmol/L \[54 mg/dL\]) requiring the assistance of another person because of severe impairment in consciousness or behavior (whether or not symptoms of hypoglycemia are detected by the patient). Mean event rate = total number of events for all subjects in a treatment regimen / the total number of subject years of exposure for all subjects in that treatment. Standard error = square root of (total number of events / (subject years of exposure)\*\*2).
Time frame: Baseline to Week 26
Assessment on Event Rate of Treatment-Emergent Minor Hypoglycemic Events
Minor hypoglycemia is defined as a sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose \<3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Mean event rate = total number of events for all subjects in a treatment regimen / the total number of subject years of exposure for all subjects in that treatment. Standard error = square root of (total number of events / (subject years of exposure)\*\*2).
Time frame: Baseline to Week 26
Change in Systolic Blood Pressure From Baseline to Week 26.
Change in Systolic Blood Pressure from baseline to Week 26.
Time frame: Baseline, Week 26
Change in Diastolic Blood Pressure From Baseline to Week 26.
Change in Diastolic Blood Pressure from baseline to Week 26.
Time frame: Baseline, Week 26