Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus

AstraZeneca464 enrolled

Overview

Study D5553C00002 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 3 study to compare the safety and efficacy of exenatide once weekly (EQW) added to titrated basal insulin glargine with or without metformin to placebo added to titrated basal insulin glargine with or without metformin in patients with type 2 diabetes mellitus (T2DM). Eligible patients will be randomized at Visit 5 (Day 1) to receive either EQW added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, or placebo added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, during the 28-week treatment period.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

464

Conditions

Diabetes Mellitus

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 130 Years

Medical Language ↔ Plain English

Inclusion criteria: * Has a diagnosis of Type 2 Diabetes Mellitus (T2DM) * Has HbA1c of 7.5% to 12.0%, inclusive, at Visit 1 (Screening). * Has fasting plasma glucose (FPG) concentration \<280 mg/dL (15.6 mmol/L) at Visit 1 (Screening) * Treated with basal insulin glargine at a dose of ≥20 units/day once daily for at least 6 weeks prior to Screening, in combination with diet and exercise alone or in combination with: 1. a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to Visit 1 2. a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to Visit 1 (Screening) and a stable dose of sulfonylurea for at least 8 weeks prior to the Screening visit Exclusion criteria: * Serum calcitonin concentration ≥40 pg/mL (≥40 ng/L) at Visit 1 (Screening) * History of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations ≥500 mg/dL (≥5.65 mmol/L) at Visit 1 * Positive serological test for hepatitis B or hepatitis C

Locations (123)

Research Site

Birmingham, Alabama, United States

Research Site

Huntsville, Alabama, United States

Research Site

Muscle Shoals, Alabama, United States

Research Site

Tempe, Arizona, United States

Research Site

Chino, California, United States

Research Site

Outcomes

Primary Outcomes

Change in HbA1c From Baseline to Week 28

To compare the change from baseline in HbA1c achieved with exenatide once weekly (EQW) added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment. SU= sulfonylurea.