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Safety and Efficacy of Exenatide as Monotherapy

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: exenatide (Drug); exenatide (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
James Malone, MD, Study Director, Affiliation: Eli Lilly and Company

Summary

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.

Clinical Details

Official title: Safety and Efficacy of Exenatide as Monotherapy in Drug Naive Patients With Type 2 Diabetes

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

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

Secondary outcome:

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

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

Change in body weight from Baseline to Week 24

Change in glucose measurements from Baseline to Week 24

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

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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- Have previously completed or withdrawn from this study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 and Contacts

Research Site, Aligarh, India

Research Site, Bangalore, India

Research Site, Chennai, India

Research Site, Indore, India

Research Site, Karnal, India

Research Site, New Delhi, India

Research Site, Vellore, India

Research Site, Manati, Puerto Rico

Research Site, San Juan, Puerto Rico

Research Site, Alba Iulia, Romania

Research Site, Baia Mare, Romania

Research Site, Bucuresti, Romania

Research Site, Galati, Romania

Research Site, Oradea, Romania

Research Site, Targu Mures, Romania

Research Site, Moscow, Russian Federation

Research Site, St. Petersburg, Russian Federation

Research Site, Idaho Falls, Idaho, United States

Research Site, Indianapolis, Indiana, United States

Additional Information

Starting date: September 2006
Last updated: February 20, 2015

Page last updated: August 23, 2015

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