This is a multicenter, comparator-controlled, open-label, randomized, two-arm, parallel trial to compare the effect of exenatide twice daily and insulin glargine on glycemic control, as measured by hemoglobin A1c (HbA1c).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
551
subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 22 weeks
subcutaneous injection, once daily; forced titration to target blood glucose level
Change in Glycosylated Hemoglobin (HbA1c)
Change in HbA1c from baseline to week 26
Time frame: Baseline, week 26
Percentage of Patients Achieving HbA1c <=7%
Percentage of patients in each arm who had HbA1c \>7% at baseline and had HbA1c \<=7% at week 26 (percentage = \[number of subjects with HbA1c \<=7% at week 26 divided by number of subjects with HbA1c \>7% at baseline\] \* 100%).
Time frame: 26 weeks
Change in Body Weight
Change in body weight from baseline to week 26
Time frame: Baseline, week 26
Change in Fasting Serum Glucose
Change in fasting serum glucose from baseline to week 26
Time frame: Baseline, week 26
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 26
Time frame: Baseline, week 26
Percentage of Patients With Hypoglycemic Events
Percentage of patients who experienced at least one episode of hypoglycemia at any point during the 26 week Parent Study (incidence of hypoglycemia = number of patients who experienced at least one episode of hypoglycemia at any point during the 26 week Parent Study divided by the total number of patients who participated in the 26 week Parent Study
Time frame: 26 weeks
Change in Rate of Hypoglycemic Events
Change in rate of hypoglycemic events per 30 days per patient from baseline to week 26
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Radiant Research-San Diego
San Diego, California, United States
Dorothy L. and James E. Frank Diabetes Research Institute
San Mateo, California, United States
Internal Medicine Associates Department of Research
Fort Myers, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Baptist Diabetes Associates
Miami, Florida, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, United States
Springfield Diabetes & Endocrine Center
Springfield, Illinois, United States
Frederick Primary Care Associates
Frederick, Maryland, United States
Radiant Research, Inc.
St Louis, Missouri, United States
Lovelace Scientific Resources, Inc.
Las Vegas, Nevada, United States
...and 81 more locations
Time frame: Baseline, week 26