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Clinical Trial Details

Trial ID: L3760
Source ID: NCT00085969
Associated Drug: Placebo 0.04 Ml Twice Daily
Title: Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Placebo 0.04 mL twice daily|DRUG: Placebo 0.04 mL once daily|DRUG: Placebo 0.08 mL once daily|DRUG: B - Exenatide 10 mcg twice daily|DRUG: C - Exenatide 10 mcg once daily|DRUG: Exenatide 20 mcg once daily
Outcome Measures: Primary: Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28, Change in HbA1c from Baseline Visit 3 (Day 1) to study termination (Day 28), Baseline, Day 28 | Secondary: Change in serum fructosamine concentration from Baseline to Day 14 and to Day 28, Change in serum fructosamine concentration from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28), Baseline, Day 14, Day 28|Change in body weight from Baseline to Day 14 and to Day 28, Change in body weight from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28), Baseline, Day 14, Day28|Change in fasting plasma glucose concentration from Baseline to Day 14 and to Day 28, Change in fasting plasma glucose concentration from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28), Baseline, Day 14, Day 28|Change in postprandial blood glucose concentrations from Baseline to Day 28, Change in postprandial blood glucose concentrations from Baseline Visit 3 (Day 1) to study termination (Day 28), Baseline, Week 28
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 99
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2003-09
Completion Date: 2004-01
Results First Posted:
Last Update Posted: 2015-02-23
Locations: The Whittier Institute for Diabetes, La Jolla, California, 92037, United States|VA Medical Center, San Diego, California, 92161, United States|MedStar Research Institute, Washington, District of Columbia, 20003, United States|Internal Medicine Associates, Department of Research, Fort Myers, Florida, 33901, United States|Jacksonville Center for Clinical Research, Jacksonville, Florida, 32216, United States|Innovative Research of West Florida, Largo, Florida, 33770, United States|Henry Ford Health System, Detroit, Michigan, 48202, United States|Grand Rapids Associated Internists, Grand Rapids, Michigan, 49506, United States|Radiant Research, Inc., St. Louis, Missouri, 63141, United States|Internal Medicine Associates, Bozeman, Montana, 59715, United States|Mercury Street Medical Group, Butte, Montana, 59701, United States|Lovelace Scientific Resources, Las Vegas, Nevada, 89128, United States|Rochester Clinical Research, Inc., Rochester, New York, 14609, United States|Metrolina Medical Research, Charlotte, North Carolina, 28209, United States|Piedmont Medical Research Associates, Winston-Salem, North Carolina, 27103, United States|Radiant Research, Columbus, Ohio, 43212, United States|Smith Clinic Research, Marion, Ohio, 43302, United States|Radiant Research, Portland, Oregon, 97239, United States|Philadelphia Health Associates - Adult Medicine, Philadelphia, Pennsylvania, 19146, United States|Diabetes and Glandular Disease Research Associates, San Antonio, Texas, 78229-4801, United States|S.A.M. Clinical Research Center, San Antonio, Texas, 78229, United States|McGuire VA Medical Center, Richmond, Virginia, 23249, United States|Rockwood Clinic, Spokane, Washington, 99202, United States
URL: https://clinicaltrials.gov/show/NCT00085969

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress