This study will examine the safety of exenatide once weekly (2.0 mg) in approximately 134 patients receiving treatment with thiazolidinedione alone or thiazolidinedione in combination with metformin. Patients are expected to be treated with exenatide once weekly for at least 52 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
134
subcutaneous injection, 2.0mcg, once weekly
Research Site
Mesa, Arizona, United States
Research Site
Percentage of Patients Experiencing Adverse Events
Percentage of patients experiencing treatment-emergent adverse events over 52 weeks
Time frame: Baseline to Week 52
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. 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 52
Change in HbA1c From Baseline to Week 52
Change in HbA1c from baseline to endpoint
Time frame: Baseline, Week 52
Percentage of Patients Achieving HbA1c <=7% at Week 52
Percentage of patients achieving HbA1c \<=7% at endpoint (for patients with HbA1c \>7% at baseline)
Time frame: Baseline, Week 52
Percentage of Patients Achieving HbA1c <=6.5% at Week 52
Percentage of patients achieving HbA1c \<=6.5% at endpoint (for patients with HbA1c \>6.5% at baseline)
Time frame: Baseline, Week 52
Change in Fasting Serum Glucose From Baseline to Week 52
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Tempe, Arizona, United States
Research Site
Concord, California, United States
Research Site
Fresno, California, United States
Research Site
La Mesa, California, United States
Research Site
Atlanta, Georgia, United States
Research Site
Idaho Falls, Idaho, United States
Research Site
Bowling Green, Kentucky, United States
Research Site
Corvallis, Oregon, United States
Research Site
Chattanooga, Tennessee, United States
...and 16 more locations
Change in fasting serum glucose from baseline to endpoint
Time frame: Baseline, Week 52
Change in Body Weight From Baseline to Week 52
Change in body weight from baseline to endpoint
Time frame: Baseline, Week 52
Change in Total Cholesterol From Baseline to Week 52
Change in Total Cholesterol from baseline to endpoint
Time frame: Baseline, Week 52
Change in High-density Lipoprotein (HDL) From Baseline to Week 52
Change in HDL from baseline to endpoint
Time frame: Baseline, Week 52
Change in Triglycerides From Baseline to Week 52
Change in Triglycerides from baseline to endpoint
Time frame: Baseline, Week 52
Change in Blood Pressure From Baseline to Week 52
Change in Systolic and Diastolic Blood Pressure from baseline to endpoint
Time frame: Baseline, Week 52