This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control, as measured by hemoglobin A1c (HbA1c), in patients with type 2 diabetes who experience inadequate glycemic control with OAD alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
182
After a 2-week placebo lead-in period (twice daily, given subcutaneously) in addition to their current therapy regimen, subjects will administer 20 mcg of exenatide (2 units \[5 μg\] ), twice daily by subcutaneous injection, for the first 4 weeks of therapy, and then 40 μL of study drug (4 units \[10 μg\] of exenatide) twice daily by subcutaneous injection, for the remaining 12 weeks of therapy.
After a 2-week placebo lead-in period (twice daily, given subcutaneously) in addition to their current therapy regimen, subjects will administer placebo (in equivalent amounts to exenatide) for 16 weeks of therapy.
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 16, and if measured, any visits in between
Change in HbA1c from Baseline (Visit 3) to study termination at Week 16, and at all study visits in between
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16
Change from Baseline to Week 16 in fasting serum glucose (FSG) and glucose
Change from Baseline to Week 16 in FSG and glucose measured at different times throughout the day derived from 7-point self-monitored glucose (SMG) profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime)
Time frame: Baseline, Week 16
Percentage of subjects reaching the target HbA1c (<7%)
The percentage of subjects reaching the target HbA1c (\<7%) will be summarized and compared by treatment
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
Change in body weight from Baseline to Week 16
Change in body weight (kg) from Baseline to Week 16
Time frame: Baseline, Week 16
Change from Baseline to Week 16 in fasting serum glucose (FSG) and glucose
Change from Baseline to Week 16 in FSG and glucose measured at different times throughout the day derived from 7-point self-monitored glucose (SMG) profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime)
Time frame: Baseline, Week 16
Changes in beta cell function and insulin sensitivity between Baseline and Week 16
Changes in beta cell function and insulin sensitivity as assessed by homeostasis model assessment (HOMA) analyses and the proinsulin/insulin ratio Between Baseline and Week 16
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Birmingham, Alabama, United States
Research Site
La Jolla, California, United States
Research Site
San Mateo, California, United States
Research Site
Santa Barbara, California, United States
Research Site
Spring Valley, California, United States
Research Site
Hialeah, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Melbourne, Florida, United States
Research Site
West Palm Beach, Florida, United States
Research Site
Atlanta, Georgia, United States
...and 41 more locations
Time frame: Baseline, Week 16
Changes in lipids between Baseline and Week 16
Changes from Baseline to Week 16 in serum lipids (total cholesterol \[TC\], high-density lipoprotein cholesterol \[HDL-C\], fasting triglycerides, calculated low-density lipoprotein cholesterol \[LDL-C\]
Time frame: Baseline, Week 16