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

Condition(s) targeted: Type 2 Diabetes

Intervention: Bydureon (Drug); Placebo (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: AstraZeneca

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.

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Change in 24-hour mean weighted glucose

Secondary outcome:

Change in 24-hour mean weighted glucose

Change in Fasting Plasma Glucose (FPG)

Change in 2-hour mean weighted Postprandial Glucose (PPG)

Change in 24-hour mean weighted glucose

Change in 2-hour mean weighted PPG

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

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

Research Site, Anaheim, California, United States

Research Site, Chino, California, United States

Research Site, Los Angeles, California, United States

Research Site, North Hollywood, California, United States

Research Site, Santa Ana, California, United States

Research Site, Spring Valley, California, United States

Research Site, Tustin, California, United States

Research Site, Walnut Creek, California, United States

Research Site, Miami, Florida, United States

Research Site, Pembroke Pines, Florida, United States

Research Site, Port Orange, Florida, United States

Research Site, Marietta, Georgia, United States

Research Site, Chicago, Illinois, United States

Research Site, Edina, Minnesota, United States

Research Site, St Louis, Missouri, United States

Research Site, Butte, Montana, United States

Research Site, Las Vegas, Nevada, United States

Research Site, Franklin, Ohio, United States

Research Site, Marion, Ohio, United States

Research Site, Oklahoma City, Oklahoma, United States

Research Site, Mt Pleasant, South Carolina, United States

Research Site, Rapid City, South Dakota, United States

Research Site, Corpus Christi, Texas, United States

Research Site, Houston, Texas, United States

Research Site, Katy, Texas, United States

Research Site, Salt Lake City, Utah, United States

Research Site, Burke, Virginia, United States

Research Site, Manassas, Virginia, United States

Research Site, Olympia, Washington, United States

Starting date: December 2014
Last updated: August 3, 2015