Safety and Efficacy of Exenatide as Monotherapy

AstraZeneca233 enrolled

Overview

This Phase 3 trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo with respect to glycemic control in drug-naive patients with type 2 diabetes treated with diet and exercise.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

233

Conditions

Type 2 Diabetes Mellitus

Interventions

exenatideDRUG

Placebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day

exenatideDRUG

Placebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day, then exenatide subcutaneous injection, 10 mcg twice a day

placeboDRUG

subcutaneous injection, volume equivalent to appropriate dose of exenatide, twice a day

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with type 2 diabetes * Treating diabetes with diet and exercise * HbA1c between 6.5% and 10.0%, inclusive * Body Mass Index (BMI) between 25 kg/m\^2 and 45 kg/m\^2, inclusive Exclusion Criteria: * Have previously completed or withdrawn from this study * Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry * Have been treated with any antidiabetic agent * Have used drugs for weight loss (for example, Xenical, Meridia, Acutrim, or similar over-the counter medications) within 3 months of screening * Are currently treated with any of the following excluded medications: \* drugs that directly affect gastrointestinal motility; \* systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous, or intramuscular route used regularly (longer than 2 weeks) or used within 2 weeks immediately prior to screening for this study

Locations (19)

Research Site

Idaho Falls, Idaho, United States

Research Site

Indianapolis, Indiana, United States

Research Site

Aligarh, India

Outcomes

Primary Outcomes

Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24

Change in HbA1c from Baseline to Week 24

Time frame: Baseline, Week 24

Secondary Outcomes

Percentage of subjects achieving HbA1c of 7% or less and of 6.5% or less

Time frame: Baseline, Weeks 4, 8, 12, 16, 24

Change in fasting serum glucose (FSG) from Baseline to Week 24

Change in fasting serum glucose (FSG) from Baseline to Week 24 and, if measured, at all visits in between

Time frame: Baseline, Weeks 4, 8, 12, 16, and 24

Change in body weight from Baseline to Week 24

Change in body weight (kg) from Baseline to Week 24 and, if measured, at all visits in between

Time frame: Baseline, Weeks 4, 8, 12, 16, and 24

Change in glucose measurements from Baseline to Week 24

Change in fasting SMBG profiles (glucose measurements before and 2 hours after meals) from Baseline to Week 24 and, if measured, at all visits in between

Time frame: Baseline, Weeks 4, 8, 12, 16, 24

Changes in beta-cell function and insulin sensitivity from Baseline to Week 24

Changes in beta-cell function and insulin sensitivity as assessed by homeostasis model assessment (HOMA) analyses from Baseline to Week 24 and, if measured, at all visits in between

Time frame: Baseline, Weeks 4, 8, 12, 16, and 24

Changes in fasting and 30, 60, 120 and 180-minute glucose measurements

Data from ClinicalTrials.gov

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