Study to Evaluate the Effect of BYDUREON on 24-hour Glucose Control in Metformin Treated Patients With Type 2 Diabetes.

Study Overview
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Brief Summary
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A Randomized, Double-blind, Parallel-group Study to Evaluate the Effect of Bydureon Compared with Placebo on 24-hour Glucose Control in Metformin-treated Patients with Type 2 Diabetes.

Detailed Description
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A Randomized, Double-blind, Parallel-group Study to Evaluate the Effect of Bydureon Compared with Placebo on 24-hour Glucose Control in 110 Metformin-treated Patients with Type 2 Diabetes

Official Title
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A Randomized Double-blind, Parallel-group Study to Evaluate the Effect of BYDUREON Compared With Placebo on 24-hour Glucose Control in Metformin-treated Patients With Type 2 Diabetes

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Bydureon
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes mellitus (T2DM) treated with stable dose of metformin > or = to 1500mg/day as monotherapy for at least 8 weeks Hemoglobin A1c (HbA1c) 7% to 10% at screening Body mass index (BMI) < or = to 45 kg/m2 Exclusion Criteria: History of taking antihyperglycemic therapy other than metformin or metformin extended release (XR) during the 8 weeks prior to screening History of taking a dipeptidyl peptidase-4 (DPP-4) inhibitor or pramlintide during 12 weeks prior to screening History of potent, inhaled or intrapulmonary steroids 3 months prior to screening or during the study History of prescription or over the counter weight loss medication during 3 months prior to screening Previous exposure to exenatide or any glucagon-like peptide-1 (GLP-1) receptor agonist during 6 months prior to screening

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bydureon<br>Once weekly injected exenatide | Drug: Bydureon<br>* Once weekly injection of 2mg bydureon (extended release exenatide) for 10 weeks.<br>* Other names: exenatide;|
| Placebo Comparator: Placebo<br>Placebo comparator | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 24-hour Mean Weighted Glucose | Change in 24-hour mean weighted glucose from baseline (Day -1/1) to Day 6 of Week 4 (Day 27/28) and to Day 6 of Week 10 (Day 69/70). | Day 27/28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 24-hour Mean Weighted Glucose Between Day 1 of Week 10 (Day 64/65) and Day 6 of Week 10 (Day 69/70) Within Each EQW-treated Patient |  | Day 64/65 | 
| Change From Baseline (Day1) to Day 70 and Day 22 in FPG |  | Day 22/Day70 | 
| Change From Baseline (Day -1) to Day 64 and Day 22 in 2- Hour Mean Weighted PPG (After the Breakfast Meal) |  | Day 22 and Day 64 | 
| Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10 |  | Week 4 and Week 10 | 
| Change in HbA1c From Baseline to Day 22 and Baseline to Day 70 |  | Day 22 and Day 70 |