Safety and Efficacy of Exenatide as Monotherapy

Study Overview
=================
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.

Official Title
-----------------
Safety and Efficacy of Exenatide as Monotherapy in Drug Naive Patients With Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: exenatide
* Drug: exenatide
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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Body Mass Index (BMI) between 25 kg/m^2 and 45 kg/m^2, inclusive Exclusion Criteria: Have previously completed or withdrawn from this study Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exenatide 5 mcg/exenatide 5 mcg<br>Exenatide 5 mcg; then exenatide 5 mcg | Drug: exenatide<br>* Placebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day<br>* Other names: Byetta;|
| Experimental: Exenatide 5 mcg/exenatide 10 mcg<br>Exenatide 5 mcg, then exenatide 10 mcg | Drug: exenatide<br>* Placebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day, then exenatide subcutaneous injection, 10 mcg twice a day<br>* Other names: Byetta;|
| Placebo Comparator: Placebo<br>Placebo in volumes equivalent to exenatide | Drug: placebo<br>* subcutaneous injection, volume equivalent to appropriate dose of exenatide, twice a day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24 | Change in HbA1c from Baseline to Week 24 | Baseline, Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects achieving HbA1c of 7% or less and of 6.5% or less | Percentage of subjects achieving HbA1c of 7% or less and of 6.5% or less | Baseline, Weeks 4, 8, 12, 16, 24 | 
| Change in fasting serum glucose (FSG) from Baseline to Week 24 | Change in fasting serum glucose (FSG) from Baseline to Week 24 and, if measured, at all visits in between | Baseline, Weeks 4, 8, 12, 16, and 24 | 
| Change in body weight from Baseline to Week 24 | Change in body weight (kg) from Baseline to Week 24 and, if measured, at all visits in between | Baseline, Weeks 4, 8, 12, 16, and 24 | 
| Change in glucose measurements from Baseline to Week 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 | Baseline, Weeks 4, 8, 12, 16, 24 | 
| Changes in beta-cell function and insulin sensitivity from Baseline to Week 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 | Baseline, Weeks 4, 8, 12, 16, and 24 | 
| Changes in fasting and 30, 60, 120 and 180-minute glucose measurements | Changes in fasting and 30, 60, 120, 180-minute post glucose load blood concentrations of glucose and insulin | Immediately before glucose load, then 30, 60, 120, and 180 minutes post | 

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