This study will compare the benefits of exenatide once weekly treatment to those achieved by the approved antidiabetic therapies sitagliptin and pioglitazone in subjects whose type 2 diabetes is managed with metformin therapy alone. The safety and tolerability of the three treatment regimens will also be compared.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
514
subcutaneous injection, 2.0mg, once a week
oral tablet, 100mg, once a day
oral tablet, 45mg, once a day
Change in HbA1c From Baseline to Week 26
Absolute change in HbA1c from baseline (Day 1) to Week 26 \[Week 26 - Baseline\].
Time frame: Day 1, Week 26
Percentage of Subjects Achieving HbA1c Target of <7% at Week 26
Percentages of subjects achieving HbA1c target values of \<7% at Week 26.
Time frame: Week 26
Percentage of Subjects Achieving HbA1c Target of <=6.5% at Week 26
Percentages of subjects achieving HbA1c target values of \<=6.5% at Week 26.
Time frame: Week 26
Percentage of Subjects Achieving HbA1c Target of <=6.0% at Week 26
Percentages of subjects achieving HbA1c target values of \<=6.0% at Week 26.
Time frame: Week 26
Change in Body Weight From Baseline to Week 26
Change in body weight from baseline (Day 1) to Week 26.
Time frame: Day 1, Week 26
Change in Fasting Plasma Glucose From Baseline to Week 26
Change in fasting plasma glucose from baseline (Day 1) to Week 26.
Time frame: Day 1, Week 26
Change in Systolic Blood Pressure From Baseline to Week 26
Change in systolic blood pressure from baseline (Day 1) to Week 26.
Time frame: Day 1, Week 26
Change in Diastolic Blood Pressure From Baseline to Week 26
Change in diastolic blood pressure from baseline (Day 1) to Week 26.
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oral tablet, once a day
subcutaneous injection, once a week
Research Site
Peoria, Arizona, United States
Research Site
Artesia, California, United States
Research Site
Concord, California, United States
Research Site
Encino, California, United States
Research Site
Greenbrae, California, United States
Research Site
La Mesa, California, United States
Research Site
Orange, California, United States
Research Site
Walnut Creek, California, United States
Research Site
Whittier, California, United States
Research Site
Colorado Springs, Colorado, United States
...and 52 more locations
Time frame: Day 1, Week 26
Change in Fasting Total Cholesterol From Baseline to Week 26
Change in fasting total cholesterol from baseline (Day 1) to Week 26.
Time frame: Day 1, Week 26
Change in Fasting High-density Lipoprotein (HDL) From Baseline to Week 26
Change in fasting HDL from baseline (Day 1) to Week 26.
Time frame: Day 1, Week 26
Ratio of Fasting Triglycerides at Week 26 to Baseline
Ratio of triglycerides (measured in mg/dL) at Week 26 to baseline (Day 1). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.
Time frame: Day 1, Week 26
Assessment on Event Rate of Treatment-emergent Hypoglycemic Events
Major hypoglycemia: events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration \< 54 mg/dL prior to treatment. Minor hypoglycemia: symptoms consistent with hypoglycemia and blood glucose concentration \< 54 mg/dL prior to treatment and not classified as major hypoglycemia.
Time frame: Day 1 to Week 26