This study will compare the efficacy and safety of exenatide versus placebo in adults whose diabetes is not fully controlled by insulin glargine with or without metformin and/or pioglitazone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
261
Change in Glycosylated Hemoglobin (HbA1c)
Change in HbA1c from baseline following 30 weeks of therapy (i.e., HbA1c at week 30 minus HbA1c at baseline). Unit of measure is percent of hemoglobin that is glycosylated.
Time frame: baseline and 30 weeks
Percentage of Patients Achieving HbA1c <=7%
Percentage of patients in each arm who had HbA1c \>7% at baseline and had HbA1c \<=7% at week 30 (percentage = \[number of subjects with HbA1c \<=7% at week 30 divided by number of subjects with HbA1c \>7% at baseline\] \* 100%).
Time frame: baseline and 30 weeks
Percentage of Patients Achieving HbA1c <=6.5%
Percentage of patients in each arm who had HbA1c \>6.5% at baseline and had HbA1c \<=6.5% at week 30 (percentage = \[number of subjects with HbA1c \<=6.5% at week 30 divided by number of subjects with HbA1c \>6.5% at baseline\] \* 100%).
Time frame: baseline and 30 weeks
Change in Fasting Serum Glucose
Change in fasting serum glucose following 30 weeks of therapy (i.e., fasting serum glucose at week 30 minus fasting serum glucose at baseline)
Time frame: baseline and 30 weeks
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile
Change in 7-point (pre-breakfast, 2 hour post-breakfast, pre-lunch, 2 hour post-lunch, pre-dinner, 2 hour post-dinner, 0300 hours) SMBG profile from baseline to week 30 (change = blood glucose value at week 30 minus blood glucose value at baseline)
Time frame: baseline and 30 weeks
Change in Total Cholesterol
Change in total cholesterol following 30 weeks of therapy (i.e., total cholesterol at week 30 minus total cholesterol at baseline)
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Research Site
Peoria, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Buena Park, California, United States
Research Site
Concord, California, United States
Research Site
Fresno, California, United States
Research Site
Greenbrae, California, United States
Research Site
La Mesa, California, United States
Research Site
Lancaster, California, United States
Research Site
Northridge, California, United States
Research Site
Palm Springs, California, United States
...and 49 more locations
Time frame: baseline and 30 weeks
Change in Low Density Lipoprotein (LDL) Cholesterol
Change in LDL cholesterol following 30 weeks of therapy (i.e., LDL cholesterol at week 30 minus LDL cholesterol at baseline)
Time frame: baseline and 30 weeks
Change in High Density Lipoprotein (HDL) Cholesterol
Change in HDL cholesterol following 30 weeks of therapy (i.e., HDL cholesterol at week 30 minus HDL cholesterol at baseline)
Time frame: baseline and 30 weeks
Change in Triglycerides
Change in triglycerides following 30 weeks of therapy (i.e., triglycerides at week 30 minus triglycerides at baseline)
Time frame: baseline and 30 weeks
Change in Body Weight
Change in body weight following 30 weeks of therapy (i.e., body weight at week 30 minus body weight at baseline)
Time frame: baseline and 30 weeks
Change in Waist Circumference
Change in waist circumference following 30 weeks of therapy (i.e., waist circumference at week 30 minus waist circumference at baseline)
Time frame: baseline and 30 weeks
Change in Daily Insulin Dose
Change in daily insulin dose following 30 weeks of therapy (i.e., daily insulin dose at week 30 minus daily insulin dose at baseline)
Time frame: baseline and 30 weeks
Change in Daily Insulin Dose (on a Per Body Weight Basis)
Change in daily insulin dose per kilogram (kg) following 30 weeks of therapy (i.e., daily insulin dose per kg at week 30 minus daily insulin dose per kg at baseline)
Time frame: baseline and 30 weeks
Change in Systolic Blood Pressure (SBP)
Change in SBP following 30 weeks of therapy (i.e., SBP at week 30 minus SBP at baseline)
Time frame: baseline and 30 weeks
Change in Diastolic Blood Pressure (DBP)
Change in DBP following 30 weeks of therapy (i.e., DBP at week 30 minus DBP at baseline)
Time frame: baseline and 30 weeks
Minor Hypoglycemia Rate Per Year
Number of minor hypoglycemia events experienced per subject per year. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose \<3.0 mmol/L (54 mg/dL).
Time frame: baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30
Percentage of Subjects Experiencing Minor Hypoglycemia
Percentage of subjects in each arm experiencing at least one episode of minor hypoglycemia at any point during the study. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose \<3.0 mmol/L (54 mg/dL).
Time frame: baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30