Type 2 Diabetes Mellitus
Conditions
Keywords
diabetes, exenatide, Amylin, Lilly, monotherapy
Brief summary
This Phase 3 trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo with respect to glycemic control in drug-naive patients with type 2 diabetes treated with diet and exercise.
Interventions
DRUGexenatide
Placebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day
DRUGplacebo
subcutaneous injection, volume equivalent to appropriate dose of exenatide, twice a day
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
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with type 2 diabetes * Treating diabetes with diet and exercise * HbA1c between 6.5% and 10.0%, inclusive * Body Mass Index (BMI) between 25 kg/m\^2 and 45 kg/m\^2, inclusive
Exclusion criteria
* Have previously completed or withdrawn from this study * Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry * Have been treated with any antidiabetic agent * Have used drugs for weight loss (for example, Xenical, Meridia, Acutrim, or similar over-the counter medications) within 3 months of screening * Are currently treated with any of the following excluded medications: \* drugs that directly affect gastrointestinal motility; \* systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous, or intramuscular route used regularly (longer than 2 weeks) or used within 2 weeks immediately prior to screening for this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24 | Baseline, Week 24 | Change in HbA1c from Baseline to Week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in fasting serum glucose (FSG) from Baseline to Week 24 | Baseline, Weeks 4, 8, 12, 16, and 24 | Change in fasting serum glucose (FSG) from Baseline to Week 24 and, if measured, at all visits in between |
| Change in body weight from Baseline to Week 24 | Baseline, Weeks 4, 8, 12, 16, and 24 | Change in body weight (kg) from Baseline to Week 24 and, if measured, at all visits in between |
| Percentage of subjects achieving HbA1c of 7% or less and of 6.5% or less | Baseline, Weeks 4, 8, 12, 16, 24 | Percentage of subjects achieving HbA1c of 7% or less and of 6.5% or less |
| Changes in beta-cell function and insulin sensitivity from Baseline to Week 24 | Baseline, Weeks 4, 8, 12, 16, and 24 | Changes in beta-cell function and insulin sensitivity as assessed by homeostasis model assessment (HOMA) analyses from Baseline to Week 24 and, if measured, at all visits in between |
| Changes in fasting and 30, 60, 120 and 180-minute glucose measurements | Immediately before glucose load, then 30, 60, 120, and 180 minutes post | Changes in fasting and 30, 60, 120, 180-minute post glucose load blood concentrations of glucose and insulin |
| Change in glucose measurements from Baseline to Week 24 | Baseline, Weeks 4, 8, 12, 16, 24 | Change in fasting SMBG profiles (glucose measurements before and 2 hours after meals) from Baseline to Week 24 and, if measured, at all visits in between |
Countries
India, Puerto Rico, Romania, Russia, United States
Outcome results
None listed