Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Metformin or Sulfonylureas and Metformin

Study Overview
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Brief Summary
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This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control.

Official Title
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Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Metformin or Sulfonylureas and Metformin

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: Treated with a stable dose of one of the following for at least 3 months prior to screening: * >=1000 mg/day immediate-release metformin; or metformin >=1000 mg/day and sulfonylurea; or sulfonylurea/metformin combination therapy. HbA1c between 7.1% and 11.0%, inclusive. Body Mass Index (BMI) >21 kg/m^2 and <35 kg/m^2. Exclusion Criteria: Have participated in this study previously, or any other study using exenatide or GLP-1 analogs. Have participated in an interventional, medical, surgical, or pharmaceutical study within 30 days of screening. Have characteristics contraindicating metformin or sulfonylurea use. Have been treated with exogenous insulin for more than 1 week within the 3 months prior to screening. Have used drugs for weight loss within 1 month of screening.

Ages Eligible for Study
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Minimum Age: 21 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>Placebo lead-in; exenatide 5 mcg for 4 weeks; exenatide 10 mcg for 12 weeks | Drug: exenatide<br>* subcutaneous injection, 5mcg or 10mcg, twice a day for 16 weeks<br>* Other names: Byetta;|
| Placebo Comparator: Placebo<br>Placebo in volume equal to exenatide | Drug: Placebo<br>* subcutaneous injection twice daily in volumes equal to exenatide<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test the hypothesis that exenatide (before morning and evening meals) produces a greater decrease in HbA1c than placebo in patients with type 2 diabetes and inadequate glycemic control taking metformin alone or metformin and sulfonylureas. |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare exenatide and placebo groups with respect to: *safety and tolerability; *proportion of patients achieving HbA1c<=7%; *body weight; *incidence and rate of hypoglycemic events; *glucose measurements |  | 16 weeks | 

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