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

AstraZeneca239 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

239

Conditions

Type 2 Diabetes

Interventions

BydureonDRUG

Once weekly injection of 2mg bydureon (extended release exenatide) for 10 weeks.

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (29)

Research Site

Anaheim, California, United States

Outcomes

Primary Outcomes

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).

Time frame: Day 27/28

Secondary Outcomes

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

Time frame: Day 64/65

Change From Baseline (Day1) to Day 70 and Day 22 in FPG

Time frame: Day 22/Day70

Change From Baseline (Day -1) to Day 64 and Day 22 in 2- Hour Mean Weighted PPG (After the Breakfast Meal)

Time frame: Day 22 and Day 64

Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10

Time frame: Week 4 and Week 10

Change in HbA1c From Baseline to Day 22 and Baseline to Day 70

Time frame: Day 22 and Day 70

Data from ClinicalTrials.gov

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