Logo 1 Logo 2

Clinical Trial Details

Trial ID: L4897
Source ID: NCT00789750
Associated Drug: Colesevelam
Title: Colesevelam as Add-on to Pioglitazone Therapy for Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00789750/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Colesevelam|DRUG: Placebo|DRUG: Pioglitazone
Outcome Measures: Primary: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24, Baseline, Week 24 | Secondary: Change From Baseline in HbA1c at Week 4, Baseline, Week 4|Change From Baseline in HbA1c at Week 8, Baseline, Week 8|Change From Baseline in HbA1c at Week 16, Baseline, Week 16|Number of Participants Achieving an HbA1c Goal of <7.0%, Week 24|Change From Baseline in Fasting Plasma Glucose (FPG), In this study a reduction in FPG of at least 30 mg/dL is considered glycemic response., Baseline, Week 24|Number of Participants With a Decrease of >= 0.7 Percent in HbA1c, Week 24|Number of Participants With a Decrease of >= 0.5 Percent in HbA1c, Week 24|Number of Participants With a Reduction in FPG of >= 30 mg/dL, Week 24|Percent Change From Baseline in Total Cholesterol (TC), TC is measured in milligrams per deciliter (mg/dL), Baseline, Week 24|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C), LDL-C is measured in mg/dL, Baseline, Week 24|Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C), HDL-C is measured in mg/dL, Baseline, Week 24|Percent Change From Baseline in Non-HDL-C, Non-HDL-C is measured in mg/dL, Baseline, Week 24|Percent Change From Baseline in Triglycerides (TG), TG are measured in mg/dL, Baseline, Week 24|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-I), Apo A-1 is measured in mg/dL, Baseline, Week 24|Percent Change From Baseline in Apolipoprotein B (Apo B), Apo B is measured in mg/dL, Baseline, Week 24|Change From Baseline in Fasting Insulin Levels, Baseline, Week 24|Change From Baseline in Fasting C-peptide, Baseline, Week 24|Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), HOMA-IR is a calculation of fasting insulin and fasting glucose that shows the level of insulin resistance. Lower numbers are better., Baseline, Week 24
Sponsor/Collaborators: Sponsor: Daiichi Sankyo
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 562
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2009-04
Completion Date: 2012-07
Results First Posted: 2017-06-26
Last Update Posted: 2017-06-26
Locations: Birmingham, Alabama, 35205, United States|Birmingham, Alabama, 35216, United States|Birmingham, Alabama, 35294, United States|Montgomery, Alabama, 36106, United States|Montgomery, Alabama, 36117, United States|Green Valley, Arizona, 85614, United States|Mesa, Arizona, 85210, United States|Phoenix, Arizona, 85050, United States|Tempe, Arizona, 85282, United States|Tempe, Arizona, 85284, United States|Searcy, Arkansas, 72143, United States|Buena Park, California, 90620, United States|Burbank, California, 91505, United States|Chino, California, 91710, United States|Garden Grove, California, 92844, United States|Huntington Park, California, 90255, United States|La Mirada, California, 90638, United States|Lincoln, California, 95648, United States|Lomita, California, 90717, United States|Los Gatos, California, 95032, United States|Modesto, California, 95355, United States|San Diego, California, 92161, United States|Santa Ana, California, 92701, United States|Tustin, California, 92780, United States|Walnut Creek, California, 94598, United States|Coral Gables, Florida, 33134, United States|DeLand, Florida, 32720, United States|Delray Beach, Florida, 33484, United States|Gulf Breeze, Florida, 32561, United States|Hialeah, Florida, 33012, United States|Jacksonville, Florida, 32223, United States|Kissimmee, Florida, 34741, United States|Miami, Florida, 33135, United States|Miami, Florida, 33156, United States|Miami, Florida, 33169, United States|Miami, Florida, 33175, United States|Miami, Florida, 33183, United States|New Port Richey, Florida, 34652, United States|Ocala, Florida, 34471, United States|Ormond Beach, Florida, 32174, United States|Pembroke Pines, Florida, 33026, United States|Pembroke Pines, Florida, 33027, United States|Pinellas Park, Florida, 33781, United States|Sanford, Florida, 32771, United States|Tampa, Florida, 33607, United States|Vero Beach, Florida, 32960, United States|Wellington, Florida, 33449, United States|Winter Haven, Florida, 33880, United States|Winter Park, Florida, 32789, United States|Winter Park, Florida, 32792, United States|Columbus, Georgia, 31904, United States|Decatur, Georgia, 30035, United States|East Point, Georgia, 30344, United States|Marietta, Georgia, 30066, United States|Roswell, Georgia, 30076, United States|Stockbridge, Georgia, 30281, United States|Tucker, Georgia, 30084, United States|Waycross, Georgia, 31501, United States|Nampa, Idaho, 83686, United States|Arlington Heights, Illinois, 60004, United States|Chicago, Illinois, 60607, United States|Bloomington, Indiana, 47403, United States|Evansville, Indiana, 47714, United States|LaPorte, Indiana, 46350, United States|South Bend, Indiana, 46614, United States|Crestview Hills, Kentucky, 41017, United States|Paducah, Kentucky, 42003, United States|Lafayette, Louisiana, 70503, United States|Prince Frederick, Maryland, 20678, United States|Silver Spring, Maryland, 20910, United States|New Bedford, Massachusetts, 02740, United States|Southfield, Michigan, 48034, United States|Brooklyn Center, Minnesota, 55430, United States|Jackson, Mississippi, 39216, United States|Port Gibson, Mississippi, 39150, United States|Kansas City, Missouri, 64111, United States|Saint Louis, Missouri, 63141, United States|Billings, Montana, 59101, United States|Las Vegas, Nevada, 89123, United States|Belvidere, New Jersey, 07823, United States|Berlin, New Jersey, 08009, United States|Clifton, New Jersey, 07013, United States|Lumberton, New Jersey, 08048, United States|Mine Hill, New Jersey, 07803, United States|New Windsor, New York, 12553, United States|North Massapequa, New York, 11758, United States|Tonawanda, New York, 14150, United States|West Seneca, New York, 14224, United States|Lexington, North Carolina, 27293, United States|Statesville, North Carolina, 28625, United States|Cincinnati, Ohio, 45219, United States|Cincinnati, Ohio, 45227, United States|Cincinnati, Ohio, 45245, United States|Cleveland, Ohio, 44122, United States|Columbus, Ohio, 43213, United States|Cuyahoga Falls, Ohio, 44223, United States|Marion, Ohio, 43302, United States|Shaker Heights, Ohio, 44120, United States|Stow, Ohio, 44224, United States|Oklahoma City, Oklahoma, 73103, United States|Oklahoma City, Oklahoma, 73132, United States|Oklahoma City, Oklahoma, 73159, United States|Portland, Oregon, 97220, United States|Harrisburg, Pennsylvania, 17112, United States|Jersey Shore, Pennsylvania, 17740, United States|Philadelphia, Pennsylvania, 19140, United States|Philadelphia, Pennsylvania, 19153, United States|Upper Saint Clair, Pennsylvania, 15241, United States|Charleston, South Carolina, 29412, United States|Charleston, South Carolina, 29414, United States|Columbia, South Carolina, 29201, United States|Greer, South Carolina, 29651, United States|Germantown, Tennessee, 38138, United States|Jackson, Tennessee, 38305, United States|Murfreesboro, Tennessee, 37130, United States|New Tazewell, Tennessee, 37825, United States|Arlington, Texas, 76012, United States|Dallas, Texas, 75230, United States|Dallas, Texas, 75231, United States|Dallas, Texas, 75235, United States|Fort Worth, Texas, 76117, United States|Grand Prairie, Texas, 75052, United States|Houston, Texas, 77008, United States|Houston, Texas, 77074, United States|Houston, Texas, 77081, United States|Houston, Texas, 77083, United States|San Antonio, Texas, 78209, United States|San Antonio, Texas, 78229, United States|Sugar Land, Texas, 77478, United States|Sugar Land, Texas, 77479, United States|Tomball, Texas, 77375, United States|Salt Lake City, Utah, 84102, United States|Salt Lake City, Utah, 84107, United States|Alexandria, Virginia, 22304, United States|Danville, Virginia, 24541, United States|Manassas, Virginia, 20110, United States|Richmond, Virginia, 23225, United States|Salem, Virginia, 24153, United States|Suffolk, Virginia, 23435, United States|Lakewood, Washington, 98499, United States|Kenosha, Wisconsin, 53142, United States
URL: https://clinicaltrials.gov/show/NCT00789750

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D336 Pioglitazone small molecule DB01132 Details