The purpose of this study is to compare the effects of 2.0 mg exenatide once weekly and insulin glargine, titrated to glucose targets using the algorithm described by Yki- Järvinen et al.(2007), with respect to glycemic improvements, body weight, fasting lipids, safety, and tolerability.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
467
subcutaneous injection, 2.0mcg, once weekly
subcutaneous injection, variable dose, QD
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 <=7.0% at Week 26
Percentage of patients achieving HbA1c \<=7.0% at Week 26 (for patients with HbA1c \>7% at baseline)
Time frame: Baseline, Week 26
Percentage of Patients Achieving HbA1c <=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 (mmol/L) from Baseline to Week 26
Time frame: Baseline, Week 26
Change in Body Weight (BW) From Baseline to Week 26
Change in BW (kg) from Baseline to Week 26
Time frame: Baseline, Week 26
Change in Total Cholesterol From Baseline to Week 26
Change in Total Cholesterol (mmol/L) from Baseline to Week 26
Time frame: Baseline, Week 26
Change in High-density Lipoprotein Cholesterol (HDL) From Baseline to Week 26
Change in HDL (mmol/L) from Baseline to Week 26
Time frame: Baseline, Week 26
Ratio of Triglycerides at Week 26 to Baseline
Ratio of Triglycerides (measured in mmol/L) at Week 26 to Baseline. Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.
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Research Site
Escondido, California, United States
Research Site
Jacksonville, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
West Palm Beach, Florida, United States
Research Site
Honolulu, Hawaii, United States
Research Site
Idaho Falls, Idaho, United States
Research Site
Minneapolis, Minnesota, United States
Research Site
St Louis, Missouri, United States
Research Site
Dayton, Ohio, United States
Research Site
Ada, Oklahoma, United States
...and 65 more locations
Time frame: Baseline, Week 26
Change in Blood Pressure From Baseline to Week 26
Change in Systolic Blood Pressure (mmHg) and Diastolic Blood Pressure (mmHg) from Baseline to Week 26
Time frame: Baseline, Week 26
Assessment on Event Rate of Treatment-emergent Hypoglycemic Episodes
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 time a patient felt that he or she was experiencing a sign or symptom of hypoglycemia that was self-treated or resolved on its own and had a blood glucose level \<3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia.
Time frame: Baseline to Week 26