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Clinical Trial Details

Trial ID: L5010
Source ID: NCT00035984
Associated Drug: Ac2993
Title: Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Interventions: DRUG: AC2993|DRUG: AC2993|DRUG: Placebo|DRUG: Placebo
Outcome Measures: Primary: Change in HbA1c from Baseline to Week 30, Change in HbA1c from Baseline (Day 1) to study termination (Week 30), Baseline (Day 1) to Week 30 | Secondary: Change in HbA1c from baseline (Day 1) to each of the intermediate visits, Change in HbA1c from baseline, measured from Visit 3 (Day 1) to each of the intermediate visits (Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, and Week 24), Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24|The number of subjects achieving HbA1c target values of < 7% and < 8% by Week 30, The number of subjects achieving HbA1c target values of \< 7% and \< 8% by study termination (Week 30), Baseline (Day 1) and Week 30|The number of subjects achieving HbA1c reductions of > 0.5% and > 1.0% by Week 30, The number of subjects achieving HbA1c reductions of \> 0.5% and \> 1.0% by study termination (Week 30), Baseline (Day 1), and Week 30|The time to achieve specific HbA1c target values of < 7% and < 8%, The time it takes subjects to achieve HbA1c target values of \< 7% and \< 8%, Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24, Week 30|The time to achieve HbA1c reductions of 0.5% or more and >1.0% or more, The time it takes subjects to achieve HbA1c reductions of 0.5% or more and \>1.0% or more, Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24, Week 30|Change in body weight from Baseline to each intermediate visit and Week 30, Change in body weight (kg) from Baseline to each intermediate visit and Week 30, Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: CHILD, ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 734
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2002-05
Completion Date: 2003-08
Results First Posted:
Last Update Posted: 2015-02-24
Locations: Pinnacle Research Group, Anniston, Alabama, 36207, United States|Parkway Medical Center, Birmingham, Alabama, 35206, United States|Extended Arm Physicians/ Southern Drug, Montgomery, Alabama, 36106, United States|Southern Drug Research Network, Tallassee, Alabama, 36078, United States|First Care Family Doctors, Fayetteville, Arkansas, 72701, United States|Physicians Group Research Clinic, LLC, Little Rock, Arkansas, 72205, United States|Advanced Clinical Research Institute, Anaheim, California, 92801, United States|East Bay Clinical Trial Center, Concord, California, United States|Medical Group of Encino, Encino, California, 91436, United States|Valley Research, Fresno, California, 93720, United States|St. Joseph Heritage Healthcare, Fullerton, California, 92835, United States|Whittier Institute for Diabetes, La Jolla, California, 92037, United States|Richard Cherlin, M.D., Los Gatos, California, 95032, United States|Dr. Martinez Medical Clinic, Moreno Valley, California, 92553, United States|Comprehensive Diabetes-Endocrine Medical Associates, Redwood City, California, 94062, United States|Radiant Research-San Diego, San Diego, California, 92108, United States|Veterans Medical Research Foundation, San Diego, California, 92161, United States|Diablo Clinical Research, Walnut Creek, California, United States|Creekside Endocrine Associates, Denver, Colorado, 80209, United States|University of Colorado-Barbara Davis Center for Childhood Diabetes, Denver, Colorado, 80262, United States|Medstar Clinical Research, Washington, District of Columbia, 20003-4393, United States|George Washington University, Washington, District of Columbia, 20037, United States|Medical Research Unlimited, Aventura, Florida, United States|Morton Plant Mease Health Care, Clearwater, Florida, 33756, United States|Clinical Research of West Florida, Inc., Clearwater, Florida, 33765, United States|Internal Medicine Associates, Ft. Myers, Florida, United States|Clin Sci International, Gainesville, Florida, 32605, United States|Northeast Florida Endocrine & Diabetes Research, Jacksonville, Florida, 32204, United States|Jupiter Research Institute, Jupiter, Florida, 33458, United States|Baptist Diabetes Associates, Miami, Florida, 33176, United States|Comprehensive NeuroScience Inc., Sarasota, Florida, 34232, United States|Tallahassee Endocrine Associates, Tallahassee, Florida, 32308, United States|Metabolic Research Institute, Inc., West Palm Beach, Florida, 33401, United States|Columbus Metabolic Foundation, Columbus, Georgia, 31901, United States|University of Hawaii-Diabetes Research Group, Ewa Beach, Hawaii, 96706, United States|University Primary Care Center at Belvidere, Belvidere, Illinois, 61008, United States|Northwestern Memorial Physicians Group, Chicago, Illinois, 60602, United States|Illinois Center for Clinical Trials, Chicago, Illinois, 60610, United States|Cook County Hospital, Chicago, Illinois, 60612, United States|American Health Network, Indianapolis, Indiana, 46222, United States|Indiana University Outpatient Clinical Research, Indianapolis, Indiana, United States|Lipid, Atherosclerosis & Metabolic Clinic, Kansas City, Kansas, 66160, United States|Kentucky Diabetes Center, Lexington, Kentucky, 40503, United States|Central Kentucky Research Associates, Lexington, Kentucky, 40509, United States|University of Kentucky Metabolic Research Group, Lexington, Kentucky, 40536-9841, United States|MedResearch, Inc., Louisville, Kentucky, 40223, United States|New Orleans Center for Clinical Research, New Orleans, Louisiana, 70119, United States|Ochsner Clinic, New Orleans, Louisiana, 70121, United States|University of Maryland-Joslin Diabetes Center, Baltimore, Maryland, 21012, United States|Clinica Research Inc., Waltham, Massachusetts, 02154, United States|Henry Ford Health System, Detroit, Michigan, United States|Grand Rapids Associated Interns, Grand Rapids, Michigan, United States|International Diabetes Center, Minneapolis, Minnesota, 55416, United States|University of Mississippi Medical Center, Jackson, Mississippi, 39216, United States|Diabetes and Endocrinology Specialists, Chesterfield, Missouri, 63017, United States|Medical Arts Research Collaborative, Excelsior Springs, Missouri, 64024, United States|St Lukes Lipid and Diabetes Research Center, Kansas City, Missouri, 64111, United States|Mid Missouri Research Specialists, Inc., Rolla, Missouri, 65401, United States|Radiant Research-St. Louis, St. Louis, Missouri, 63141, United States|Midwest Pharmaceutical Research, St. Peters, Missouri, 63376, United States|Mercury Street Medical, Butte, Montana, 59701, United States|Lovelace Scientific Resources-Las Vegas, Las Vegas, Nevada, 89102, United States|Lisa Abbott, MD, Reno, Nevada, 89502, United States|SUNY Downstate, Brooklyn, New York, 11203, United States|St. Lukes Roosevelt Hospital, New York, New York, 10025, United States|Rochester Clinical Research, Rochester, New York, 14609, United States|DOCS at Beth Israel Medical Center, Yonkers, New York, 10710, United States|Charlotte Clinical Research, Charlotte, North Carolina, 28211, United States|UNC Diabetes Care Center, Durham, North Carolina, 27713, United States|Unifour Medical Research, Hickory, North Carolina, 28601, United States|New Hanover Medical Research Associates, Wilmington, North Carolina, 28412, United States|Radiant Research-Columbus, Columbus, Ohio, 43212, United States|University Mednet, Mentor, Ohio, 44060, United States|OU Health Sciences Center, Oklahoma City, Oklahoma, 73104, United States|Medford Medical Clinic, Medford, Oregon, 97504, United States|Radiant Research, Portland, Oregon, United States|Physicians for Clinical Research, Camp Hill, Pennsylvania, United States|Thomas Jefferson University Diabetes Research Center, Philadelphia, Pennsylvania, 19107, United States|Albert Einstein Medical Center, Philadelphia, Pennsylvania, 19141, United States|Philadelphia Health Associates, Philadelphia, Pennsylvania, 19146, United States|Medical University of South Carolina, Charleston, South Carolina, 29425, United States|CNS Clinical Trials, Chester, South Carolina, 29706, United States|Coastal Carolina Research Center, Mt. Pleasant, South Carolina, 29464, United States|Holston Medical Group, Kingsport, Tennessee, 37660, United States|The Endocrine Clinic, Memphis, Tennessee, 38119, United States|Mid State Endocrine Associates, Nashville, Tennessee, 37203, United States|Israel A. Hartman, M.D., Arlington, Texas, 76014, United States|Dallas Diabetes and Endocrinology Research Center, Dallas, Texas, 75230, United States|Texas Tech University Health Sciences-Internal Medicine, El Paso, Texas, 79905, United States|North Texas Clinical Research, Irving, Texas, 75038, United States|University of Texas Health Sciences Center-Texas Diabetes Institute, San Antonio, Texas, 78207, United States|Diabetes and Glandular Disease Clinic, San Antonio, Texas, 78229-3894, United States|SAM Clinical Research, San Antonio, Texas, 78229, United States|Utah Diabetes Center at the University of Utah, Salt Lake City, Utah, 84108, United States|Salt Lake Research, Salt Lake City, Utah, 84124, United States|Medical Associates of Northern Virginia, Arlington, Virginia, 22204, United States|West Olympia Internal Medicine, Olympia, Washington, 98502, United States|Rockwood Clinic, Spokane, Washington, 99202, United States|University of Wisconsin West Clinic, Madison, Wisconsin, 53711, United States|Midwest Endocrinology Associates, Milwaukee, Wisconsin, 53215, United States
URL: https://clinicaltrials.gov/show/NCT00035984