Type 2 Diabetes Mellitus
Conditions
Keywords
exenatide, exendin-4, diabetes, Amylin, Lilly
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.
Interventions
DRUGexenatide
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.
DRUGPlacebo
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.
Sponsors
Eli Lilly and Company
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| 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 \[LDL-C\] |
| 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 |
| Change in body weight from Baseline to Week 16 | Baseline, Week 16 | Change in body weight (kg) from Baseline to Week 16 |
Countries
Canada, Spain, United States
Outcome results
None listed