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 lessChange 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- Have previously completed or withdrawn from this study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
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