Previous studies have suggested that a once-weekly formulation of exenatide may provide sustained glycemic control. These previous studies of exenatide once weekly have been conducted in non-Asian populations, so this study has been developed to support the local regulatory requirements of China, Korea, Japan, India, and Taiwan.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
691
2.0mg subcutaneous injection, once a week
5mcg subcutaneous injection twice a day (4 weeks), 10mcg subcutaneous injection twice a day (22 weeks)
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 Targets <=7% at Week 26
Percentage of patients achieving HbA1c \<=7% at Week 26 (for patients with HbA1c \>7% at baseline).
Time frame: Baseline, Week 26
Percentage of Patients Achieving HbA1c Targets <=6.5% at Week 26
Percentage of patients achieving HbA1c \<=6.5% at Week 26 (for patients with HbA1c \>6.5% at baseline).
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 (BW) From Baseline to Week 26
Change in BW from baseline to Week 26.
Time frame: Baseline, Week 26
Change in Total Cholesterol (TC) From Baseline to Week 26
Change in TC from baseline to Week 26.
Time frame: Baseline, Week 26
Change in High-Density Lipoprotein (HDL) From Baseline to Week 26
Change in HDL from baseline to Week 26.
Time frame: Baseline, Week 26
Ratio of Triglycerides (TG) at Week 26 to Baseline
Ratio of TG (measured in mg/dL) at Week 26 to baseline. Log(Post-baseline TG) - log(Baseline TG); change from baseline to Week 26 is presented as ratio of Week 26 to baseline.
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Research Site
Beijing, China
Research Site
Chengdu, China
Research Site
Chongqin, China
Research Site
Guangzhou, China
Research Site
Shanghai, China
Research Site
Ahmedabad, India
Research Site
Aligarh, India
Research Site
Bangalore, India
Research Site
Ghaziabad, India
Research Site
Hyderabaad, India
...and 32 more locations
Time frame: Baseline, Week 26
Change in Blood Pressure From Baseline to Week 26
Change in systolic blood pressure and diastolic blood pressure from baseline to Week 26.
Time frame: Baseline, Week 26
Assessment of Event Rate of Treatment-emergent Hypoglycemic Events
Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose \<3.0 mmol/L \[54 mg/dL\]) and required the assistance of another person. Minor hypoglycemia: any 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. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)\*365.25 where exposure = last post-baseline visit date - baseline visit date. Mean and Standard Error were then derived from ITT.
Time frame: Baseline to Week 26