Effect of Exenatide on 24-Hour Blood Glucose Profile Compared With Placebo in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Exenatide on 24-Hour Blood Glucose Profile Compared With Placebo in Patients With Type 2 Diabetes Using Metformin or Metformin Plus a Thiazolidinedione

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: exenatide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exenatide<br>Exenatide and the subject's current oral antidiabetic agent regimen | Drug: exenatide<br>* subcutaneous injection, 5mcg twice a day for one week; then 10 mcg twice a day for one week<br>* Other names: synthetic enxendin-4;|
| Placebo Comparator: Placebo<br>Placebo and the subject's current oral antidiabetic agent regimen | Drug: Placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-averaged serum glucose during a 24-hour period | Time-averaged serum glucose during a 24-hour period | Every half-hour to hour for 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the effects of exenatide and placebo on serum glucose | 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 | Each half-hour to 2 hours for 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exenatide, diabetes, Amylin, Lilly