This study will compare the effects of commercially manufactured exenatide once weekly and exenatide BID in subjects whose type 2 diabetes is managed with diet and exercise alone or with oral antidiabetic medications. The study will examine glycemic control (as measured by HbA1C), safety, and tolerability.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
254
subcutaneous injection, 2.0mg, once a week
subcutaneous injection; 5mcg (4 weeks) and 10mcg (20 weeks); twice a day
Change in HbA1c From Baseline to Week 24
Change in HbA1c from baseline (Day 1) to Week 24 \[Week 24 - Baseline\].
Time frame: Day 1, Week 24
Percentage of Subjects Achieving HbA1c Target of <7%
Percentages of subjects achieving HbA1c target value of \<7% at Week 24.
Time frame: Week 24
Percentage of Subjects Achieving HbA1c Target of <=6.5%
Percentages of subjects achieving HbA1c target values of \<=6.5% at Week 24.
Time frame: Week 24
Change in Fasting Plasma Glucose From Baseline to Week 24
Change in fasting plasma glucose from baseline (Day 1) to Week 24.
Time frame: Day 1, Week 24
Percentage of Subjects Achieving Fasting Plasma Glucose Target of <=126 mg/dL
Percentages of subjects achieving fasting plasma glucose target of \<=126 mg/dL at Week 24.
Time frame: Week 24
Change in Body Weight From Baseline to Week 24
Change in body weight from baseline (Day 1) to Week 24.
Time frame: Day 1, Week 24
Change in Sitting Systolic Blood Pressure From Baseline to Week 24
Change in systolic blood pressure from baseline (Day 1) to Week 24.
Time frame: Day 1, Week 24
Change in Sitting Diastolic Blood Pressure From Baseline to Week 24
Change in diastolic blood pressure from baseline (Day 1) to Week 24.
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Research Site
Birmingham, Alabama, United States
Research Site
Mesa, Arizona, United States
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
Walnut Creek, California, United States
Research Site
DeLand, Florida, United States
...and 31 more locations
Time frame: Day 1, Week 24
Change in Total Cholesterol From Baseline to Week 24
Change in total cholesterol from baseline (Day 1) to Week 24.
Time frame: Day 1, Week 24
Change in High-density Lipoprotein (HDL) From Baseline to Week 24
Change in HDL from baseline (Day 1) to Week 24.
Time frame: Day 1, Week 24
Ratio of Triglycerides at Week 24 to Baseline
Ratio of triglycerides (measured in mg/dL) at Week 24 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 24
Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events
The major hypoglycemia category included 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 of less than 54 mg/dL prior to treatment, whether or not symptoms of hypoglycemia were perceived by the subject.
Time frame: Day 1 to Week 24
Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events
The minor hypoglycemia category included events in which symptoms consistent with hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia.
Time frame: Day 1 to Week 24