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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 February 2013 |
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Main ID: |
NCT00381342 |
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Date of registration:
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25/09/2006 |
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Primary sponsor: |
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Public title:
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Safety and Efficacy of Exenatide as Monotherapy
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Scientific title:
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Safety and Efficacy of Exenatide as Monotherapy in Drug Naive Patients With Type 2 Diabetes |
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Date of first enrolment:
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September 2006 |
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Target sample size:
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233 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00381342 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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India
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Puerto Rico
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Romania
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Russian Federation
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United States
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Contacts
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Name:
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James Malone, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eli Lilly and Company |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes Mellitus
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Intervention(s)
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Drug: exenatide
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Drug: placebo
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Primary Outcome(s)
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Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24
[Time Frame: Baseline, Week 24]
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Secondary Outcome(s)
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Change in body weight from Baseline to Week 24
[Time Frame: Baseline, Weeks 4, 8, 12, 16, and 24]
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Change in fasting serum glucose (FSG) from Baseline to Week 24
[Time Frame: Baseline, Weeks 4, 8, 12, 16, and 24]
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Change in glucose measurements from Baseline to Week 24
[Time Frame: Baseline, Weeks 4, 8, 12, 16, 24]
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Changes in beta-cell function and insulin sensitivity from Baseline to Week 24
[Time Frame: Baseline, Weeks 4, 8, 12, 16, and 24]
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Changes in fasting and 30, 60, 120 and 180-minute glucose measurements
[Time Frame: Immediately before glucose load, then 30, 60, 120, and 180 minutes post]
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Percentage of subjects achieving HbA1c of 7% or less and of 6.5% or less
[Time Frame: Baseline, Weeks 4, 8, 12, 16, 24]
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Secondary ID(s)
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H8O-MC-GWBJ
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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