Status:
COMPLETED
Study to Evaluate the Effect of BYDUREON on 24-hour Glucose Control in Metformin Treated Patients With Type 2 Diabetes.
Lead Sponsor:
AstraZeneca
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
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
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT02288273
Start Date
December 1 2014
End Date
August 1 2015
Last Update
January 27 2017
Active Locations (29)
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1
Research Site
Anaheim, California, United States
2
Research Site
Chino, California, United States
3
Research Site
Los Angeles, California, United States
4
Research Site
North Hollywood, California, United States