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

AstraZeneca

Status and phase

Completed

Phase 4

Conditions

Type 2 Diabetes

Treatments

Drug: Bydureon

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02288273

D5551L00006

Details and patient eligibility

About

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.

Full 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

Enrollment

239 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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