Type 2 Diabetes Mellitus
Conditions
Keywords
exenatide, diabetes, Amylin, Lilly
Brief summary
The purpose of this study is to test the hypothesis that in patients with type 2 diabetes, the addition of exenatide will result in lower time-averaged serum glucose during a 24-hour period, compared with placebo.
Interventions
DRUGexenatide
subcutaneous injection, 5mcg twice a day for one week; then 10 mcg twice a day for one week
DRUGPlacebo
subcutaneous injection, equivalent volume to 5 mcg exenatide twice a day for one week; then equivalent volume to 10 mcg exenatide twice a day for one week
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 75 Years
Healthy volunteers
No
Inclusion criteria
* Subject has an HbA1c between 7.0% and 10.0%, inclusive. * Subject has a body mass index (BMI) \>25 kg/m\^2 and \<50 kg/m\^2. * Subject is on a stable dose of metformin or metformin plus a thiazolidinedione.
Exclusion criteria
* Subject has been treated with any of the following medications: \*exogenous insulin for more than 1 week within 3 months of screening, \*sulfonylureas or meglitinides within 2 months of screening, \*alpha-glucosidase inhibitors within 2 months of screening, \*pramlintide acetate injection within 2 months of screening. * Subject has received exenatide, GLP-1 analogs, DPP-IV inhibitors, or has participated in this study previously.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-averaged serum glucose during a 24-hour period | Every half-hour to hour for 24 hours | Time-averaged serum glucose during a 24-hour period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To compare the effects of exenatide and placebo on serum glucose | Each half-hour to 2 hours for 24 hours | To compare the effects of exenatide and placebo on serum glucose measured as averaged daytime glucose, averaged nighttime glucose, time-averaged postprandial glucose 2 hours after each meal, time-averaged postprandial glucose 4 hours after each meal, 2-hour postprandial glucose averaged across morning and evening meals, and averaged across the three meals, and fluctuation evaluations |
Countries
United States
Outcome results
None listed