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



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 75
Updated:4/21/2016
Start Date:December 2014
End Date:August 2015

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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

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.

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

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
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