Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin
- Registration Number
- NCT00099320
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 182
- Treated with thiazolidinedione (TZD) alone or in combination with metformin. TZD dose stable for at least 120 days prior to screening, and those patients on metformin must have been on a stable dose for at least 30 days prior to screening.
- HbA1c between 7.1% and 10.0%, inclusive.
- Body mass index (BMI) between 25 kg/m^2 and 45 kg/m^2.
- Patient previously in a study using exenatide or GLP-1 analogs.
- Treated with oral anti-diabetic medications other than TZD and metformin within 3 months of screening.
- Treated with oral insulin within 3 months of screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exenatide exenatide After a 2-week placebo lead-in period, exenatide will be given in an esclating dose along with the subject's current therapy regimen Placebo Placebo After a 2-week placebo lead-in period, subjects will be given placebo (in equivalent amounts to exenatide) in addition to their current therapy regimen.
- Primary Outcome Measures
Name Time Method Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 16, and if measured, any visits in between Baseline, Week 4, Week 8, Week 12, Week 16 Change in HbA1c from Baseline (Visit 3) to study termination at Week 16, and at all study visits in between
Change from Baseline to Week 16 in fasting serum glucose (FSG) and glucose Baseline, Week 16 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)
- Secondary Outcome Measures
Name Time Method Change in body weight from Baseline to Week 16 Baseline, Week 16 Change in body weight (kg) from Baseline to Week 16
Changes in beta cell function and insulin sensitivity between Baseline and Week 16 Baseline, 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
Changes in lipids between Baseline and Week 16 Baseline, 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 \[LDL-C\]
Percentage of subjects reaching the target HbA1c (<7%) Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 The percentage of subjects reaching the target HbA1c (\<7%) will be summarized and compared by treatment
Change from Baseline to Week 16 in fasting serum glucose (FSG) and glucose Baseline, Week 16 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)
Trial Locations
- Locations (1)
Research Site
🇪🇸Zaragoza, Spain