Efficacy and Safety of Exenatide Once Weekly Suspension in Subjects With Type 2 Diabetes

Study Overview
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Brief Summary
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To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus. To examine the long-term (52 weeks of treatment) safety and effect on glucose control of exenatide suspension administered once weekly in subjects with type 2 diabetes mellitus.

Official Title
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A Randomized, Open-Label, Long-Term, Parallel-Group, Comparator-Controlled, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Exenatide Twice Daily in Subjects With Type 2 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Exenatide once weekly suspension
* Drug: Exenatide twice daily


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years old Diagnosed with type 2 diabetes mellitus HbA1c 7.1 to 11%, inclusive, at screening Fasting plasma glucose <280 mg/dL (15.5 mmol/L) Body mass index (BMI) <=45 kg/m2, inclusive, at screening Treated with diet and exercise or a stable regimen of metformin, sulfonylurea, pioglitazone or any 2 of these agents Exclusion Criteria: History of pancreatitis or triglycerides >=500 mg/dL Medullary carcinoma or multiple endocrine neoplasia (MEN2) or a family history of either Active cardiovascular disease Presence of congestive heart failure Liver disease History of severe gastrointestinal diseases Repeated severe hypoglycemia within the last 6 months Any previous use of exenatide or other glucagon-like peptide-1 (GLP-1 ) analog Dipeptidyl peptidase-4 (DPP-4) inhibitor use in the last 3 months

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exenatide once weekly suspension<br>Exenatide suspension 2 mg weekly subcutaneous injection | Drug: Exenatide once weekly suspension<br>* Exenatide suspension 2 mg weekly subcutaneous injection<br>|
| Active Comparator: Exenatide twice daily (BID)<br>Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks | Drug: Exenatide twice daily<br>* 5 mcg twice daily for 4 weeks followed by 10 mcg twice daily for 24 weeks<br>* Other names: Byetta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28 | The primary objective of this study was to compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus. | Baseline to Week 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Achieving HbA1c <7% at Week 28 | Percentage of subjects achieving HbA1c <7% at Week 28/Study Termination | Baseline to Week 28 | 
| Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28 | Change in fasting plasma glucose concentrations from baseline to Week 28/Study Termination | Baseline to Week 28 | 
| Change in Body Weight (kg) From Baseline to Week 28 | Change in body weight (kg) from baseline to Week 28/Study Termination. | Baseline to Week 28 | 
| Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16 | Change in 2-hour postprandial glucose concentrations from baseline to Week 16. | Baseline to Week 16 |