Type 2 Diabetes
Conditions
Keywords
diabetes, exenatide, Lilly, Amylin
Brief summary
This trial is designed to compare the effects of twice-daily (before lunch and before dinner) exenatide plus oral antidiabetic (OAD) agents and twice-daily (before breakfast and before dinner) exenatide plus OAD with respect to glycemic control (HbA1c) in patients with type 2 diabetes.
Interventions
DRUGexenatide
subcutaneous injection, 5mcg or 10mcg, twice a day (before lunch and dinner)
Sponsors
Eli Lilly and Company
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with type 2 diabetes. * Have been treated with one of the following treatment regimens for at least three months prior to screening: \*metformin alone; \*sulfonylurea (SU) alone; \*thiazolidinedione (TZD) alone; \*a combination of metformin and SU; \*a combination of metformin and TZD. * HbA1c between 7.1% and 10.0%, inclusive. * Body Mass Index (BMI) \> 25 kg/m\^2 and \< 45 kg/m\^2
Exclusion criteria
* Have participated in an interventional, medical, surgical, or pharmaceutical study (a study in which an experimental drug, medical, or surgical treatment was given) within 30 days prior to screening. * Have characteristics contraindicating metformin, SU, or TZD use. * Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to screening. * Have used any prescription drug to promote weight loss within 3 months prior to screening. * Are currently treated (for greater than 2 consecutive weeks) with any of the following excluded medications: \*insulin within 3 months prior to screening; \*alpha-glucosidase inhibitors within 3 months prior to screening; \*meglitinides within 3 months prior to screening; \*drugs that directly affect gastrointestinal motility
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12 | Baseline, Week 12 | Evaluate the change in glycemic control as measured by HbA1c from Baseline to Week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight from Baseline to Week 12, and if measured, at each visit | Baseline, Weeks 4, 8, 12 | Change in body weight (kg) from Baseline to Week 12, and if measured, at each visit in between (Weeks 4 and 8) |
| Change in fasting serum glucose (FGS) from Baseline to Week 12, and if measured, at each visit | Baseline, Weeks 4, 8, 12 | Change in FGS from Baseline to Week 12, and if measured, at each visit in between (Weeks 4 and 8) |
| Changes in self-monitored blood glucose (SMBG) profile from Baseline through Week 12 | Baseline, Weeks 4, 8, 12 | Changes in glucose measured at different times throughout the day derived from 7-point SMBG profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime) |
Countries
Brazil, Mexico
Outcome results
None listed