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Clinical Trial Details

Trial ID: L7351
Source ID: NCT00643851
Associated Drug: Dapagliflozin
Title: An Efficacy & Safety Study of BMS-512148 in Combination With Metformin Extended Release Tablets
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00643851/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Dapagliflozin|DRUG: Metformin XR
Outcome Measures: Primary: Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]), HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double- blind period., From Baseline to Week 24 | Secondary: Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF]), Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 in the double-blind period., From Baseline to Week 24|Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF]), Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c \<7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Mean and standard error for percentage of participants estimated by modified logistic regression model., From Baseline to Week 24|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) in Subjects With Baseline HbA1c ≥ 9% at Week 24 (Last Observation Carried Forward [LOCF]), HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period., From Baseline to Week 24|Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF]), Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period., From Baseline to Week 24|Adjusted Mean Change From Baseline in Total Body Weight (kg) in Subjects With Baseline Body Mass Index (BMI) ≥ 27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF]), Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period., From Baseline to Week 24
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Bristol-Myers Squibb
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 994
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2008-06
Completion Date: 2009-08
Results First Posted: 2017-02-23
Last Update Posted: 2023-01-30
Locations: Greystone Medical Research, Llc, Birmingham, Alabama, 35242, United States|Winston Technology Research, Llc, Haleyville, Alabama, 35565, United States|Clinical Research Advantage, Inc., Tempe, Arizona, 85282, United States|John Muir Physician Network Clinical Research Center, Concord, California, 94520, United States|Southland Clinical Research Center, Inc., Fountain Valley, California, 92708, United States|Valley Research, Fresno, California, 93720, United States|Central Florida Clinical Trials, Inc., Altamonte Springs, Florida, 32701, United States|Clinical Therapeutics Corporation, Coral Gables, Florida, 33134, United States|Florida Research Network, Llc, Gainesville, Florida, 32605, United States|Fpa Clinical Research, Kissimmee, Florida, 34741, United States|Nextphase Clinical Trials, Inc., Miami, Florida, 33145, United States|Middle Georgia Drug Study Center, Llc, Perry, Georgia, 31069, United States|Cedar Crosse Research Center, Chicago, Illinois, 60607, United States|Deerbrook Medical Associates, Vernon Hills, Illinois, 60061, United States|Jackson Clinic, Rolling Fork, Mississippi, 39159, United States|Mercy Medical Group/Dba Woodlake Research, Chesterfield, Missouri, 63017, United States|Hudson Valley Clinical Research Center, Kingston, New York, 12401, United States|Metrolina Medical Research, Charlotte, North Carolina, 28209, United States|Crescent Medical Research, Salisbury, North Carolina, 28144, United States|Community Health Care, Inc., Canal Fulton, Ohio, 44614, United States|Wells Institute For Health Awareness, Kettering, Ohio, 45429, United States|Newark Physician Associates, Newark, Ohio, 43055, United States|Physician Research, Inc., Zanesville, Ohio, 43701, United States|Gilbert Medical Research, Llc, Bethany, Oklahoma, 73008, United States|Integris Family Care South Penn, Oklahoma City, Oklahoma, 73159, United States|Integris Family Care Yukon, Yukon, Oklahoma, 73099, United States|Willamette Valley Clinical Studies, Eugene, Oregon, 97404, United States|Commonwealth Primary Care, Pc / Fleetwood Clinical Research, Fleetwood, Pennsylvania, 19522, United States|Biomedical Research Associates, Llc, Shippensburg, Pennsylvania, 17257, United States|Safe Harbor Clinical Research, East Providence, Rhode Island, 02914, United States|Southeastern Research Associates, Inc., Greenville, South Carolina, 29605, United States|Spartanburg Medical Research, Spartanburg, South Carolina, 29303, United States|Middle Tennessee Clinical Research, Fayetteville, Tennessee, 37334, United States|Holston Medical Group, Kingsport, Tennessee, 37660, United States|Endocrine Associates, Houston, Texas, 77004, United States|Village Family Practice, Houston, Texas, 77024, United States|Non-Invasive Cardiovascular, Pa, Houston, Texas, 77074, United States|Excel Clinical Research, Llc, Houston, Texas, 77081, United States|Texas Center For Drug Development, Houston, Texas, 77081, United States|Inst. Of Clin. Research At The Diabetes Cntr. Of The Sw, Midland, Texas, 79705, United States|Hill Country Medical Associates, New Braunfels, Texas, 78130, United States|Southwest Clinical Research Center, Llc, Pearland, Texas, 77584, United States|Covenant Clinical Research, Pa, San Antonio, Texas, 78229, United States|S.A.M. Clinical Research Center, San Antonio, Texas, 78229, United States|Local Institution, Guri-Si, Gyeonggi-Do, 471-701, Korea, Republic of|Local Institution, Seoul, Nowon-Gu, 471-701, Korea, Republic of|Local Institution, Bucheon, 420-717, Korea, Republic of|Local Institution, Incheon, 105-760, Korea, Republic of|Local Institution, Incheon, 400-711, Korea, Republic of|Local Institution, Seoul, 137-040, Korea, Republic of|Local Institution, Sungnam-Si, Gyeonggi-Do, 463-070, Korea, Republic of|Local Institution, Ciudad De Mexico, Distrito Federal, 14000, Mexico|Local Institution, Pachuca, Hidelgo, 42090, Mexico|Local Institution, Guadalajara, Jalisco, 44100, Mexico|Local Institution, Guadalajara, Jalisco, 44650, Mexico|Local Institution, Guadalajara, Jalisco, 44670, Mexico|Local Institution, Morelia, Michioacan, 58070, Mexico|Local Institution, Monterrey, Nl, Nuevo Leon, 64400, Mexico|Local Institution, Monterrey, Nuevo Leon, 64000, Mexico|Local Institution, Tampico, Tamaulipas, 89000, Mexico|Local Institution, Merida, Yucatan, 97070, Mexico|Local Institution, Aguascalientes, 20127, Mexico|Local Institution, Durango, 34000, Mexico|Local Institution, Veracruz, 91910, Mexico|Local Institution, Cebu City, 6000, Philippines|Local Institution, Jaro Iloilo City, 5000, Philippines|Local Institution, Las Pinas City, 1740, Philippines|Local Institution, Marikina City, 1800, Philippines|Local Institution, Pasig City, 1600, Philippines|Local Institution, Quezon City, 1100, Philippines|Local Institution, Ponce, 00716, Puerto Rico|Local Institution, Ponce, 00717, Puerto Rico|Local Institution, San Juan, 00920, Puerto Rico|Local Institution, San Juan, 00926, Puerto Rico|Local Institution, Villa Fontana, 00983, Puerto Rico|Local Institution, Arkhangelsk, 163045, Russian Federation|Local Institution, Dzerzhinskiy, 140091, Russian Federation|Local Institution, Kemerovo, 650066, Russian Federation|Local Institution, Moscov, 119048, Russian Federation|Local Institution, Moscow, 125299, Russian Federation|Local Institution, Nizhniy Novgorod, 603018, Russian Federation|Local Institution, Novosibirsk, 630091, Russian Federation|Local Institution, Novosibirsk, 630117, Russian Federation|Local Institution, Saint-Petersburg, 190068, Russian Federation|Local Institution, Saratov, 410028, Russian Federation|Local Institution, St. Petersburg, 191015, Russian Federation|Local Institution, Volgograd, 400001, Russian Federation|Local Institution, Voronezh, 394018, Russian Federation|Local Institution, Yaroslav, 150003, Russian Federation|Local Institution, Dnepropetrovsk, 49023, Ukraine|Local Institution, Donetsk, 83003, Ukraine|Local Institution, Kiev, 04050, Ukraine|Local Institution, Kiev, 4114, Ukraine|Local Institution, Lviv, 79010, Ukraine|Local Institution, Odessa, 65009, Ukraine|Local Institution, Odessa, 65039, Ukraine|Local Institution, Odessa, 65114, Ukraine|Local Institution, Vinnytsya, 21010, Ukraine|Local Institution, Zhytomyr, 10003, Ukraine
URL: https://clinicaltrials.gov/show/NCT00643851

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D445 Dapagliflozin small molecule DB06292 Details