Clinical Trial Details
| Trial ID: | L6573 |
| Source ID: | NCT00683878 |
| Associated Drug: | Dapagliflozin |
| Title: | Add-on to Thiazolidinedione (TZD) Failures |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00683878/results |
| Conditions: | Type 2 Diabetes |
| Interventions: | DRUG: Dapagliflozin|DRUG: Dapagliflozin|DRUG: Placebo matching Dapagliflozin|DRUG: Thiazolidinedione (Pioglitazone) |
| 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 120-minute Post-challenge Plasma Glucose (PPG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF]), Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. In post oral glucose tolerance test (OGTT), 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. PPG measurements were obtained on Day 1 and week 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, 4, 8, 12, 16, 20, and 24 of the double-blind period., From Baseline to Week 24|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, 4, 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 were estimated by modified logistic regression model., From Baseline to Week 24|Adjusted Mean Change From Baseline in Waist Circumference (cm) 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 waist circumference 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. Waist circumference measurements were obtained during the qualification and lead-in periods and on Day 1 and Week 24 of the double-blind period., From Baseline to Week 24|Adjusted Mean Change From Baseline in Total Body Weight (kg) Among 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 among subjects with baseline body mass index (BMI) ≥ 27 kg/m\^2 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, 4, 8, 12, 16, 20, and 24 of the double-blind period., From Baseline to Week 24 |
| Sponsor/Collaborators: | Sponsor: AstraZeneca | Collaborators: Astra Zeneca, Bristol-Myers Squibb |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 972 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2008-07 |
| Completion Date: | 2010-06 |
| Results First Posted: | 2017-02-23 |
| Last Update Posted: | 2017-02-23 |
| Locations: | Pinnacle Research Group, Llc, Anniston, Alabama, 36207, United States|Iicr, Ozark, Alabama, 36360, United States|43rd Medical Associates, P.C., Phoenix, Arizona, 85051, United States|Clinical Research Advantage Inc / Desert Clinical Res, Llc, Tempe, Arizona, 85282, United States|Clinical Research Advantage, Inc, Tempe, Arizona, 85282, United States|Little Rock Family Practice Clinic, Little Rock, Arkansas, 72205, United States|Searcy Medical Center, Searcy, Arkansas, 72143, United States|Clinical Innovations, Inc., Costa Mesa, California, 92626, United States|Marin Endocrine Care And Research, Inc., Greenbrae, California, 94904, United States|Torrance Clinical Research, Lomita, California, 90717, United States|Randall Shue, D.O., Los Angeles, California, 90023, United States|Diabetes Medical Center Of California, Northridge, California, 91325, United States|Desert Medical Advances, Palm Desert, California, 92260, United States|Avastra Clinical Trials, Redlands, California, 92373, United States|Sierra Clinical Research, Roseville, California, 95661, United States|Ritchken & First M.D.'S, San Diego, California, 92117, United States|Advantage Clinical Research, Santa Ana, California, 92701, United States|Encompass Clinical Research, Spring Valley, California, 91978, United States|Diabetes Research Center, Tustin, California, 92780, United States|Aurora Family Medicine Center, P.C., Aurora, Colorado, 80012, United States|Denver Internal Medicine, Denver, Colorado, 80209, United States|Central Florida Clinical Trials, Altamonte Springs, Florida, 32701, United States|Health First Clinical Research Group, Inc., Chipley, Florida, 32428, United States|Clinical Therapeutics Corporation, Coral Gables, Florida, 33134, United States|Westside Center For Clinical Research, Jacksonville, Florida, 32205, United States|Panhandle Family Care Associates, Marianna, Florida, 32446, United States|Baptist Diabetes Associates, Pa, Miami, Florida, 33156, United States|Suncoast Clinical Res Inc., New Port Richey, Florida, 34652, United States|Stone Mountain Clinical Research, Stone Mountain, Georgia, 30088, United States|Cedar Crosse Research Center, Chicago, Illinois, 60607, United States|Northwest Indiana Center For Clinical Research, Valparaiso, Indiana, 46383, United States|Professional Research Network Of Kansas, Wichita, Kansas, 67203, United States|St. Mary'S Center For Diabetes And Endocrinology, Grand Rapids, Michigan, 49503, United States|Endocrine Research Associates, Jackson, Mississippi, 39216, United States|Olive Branch Family Medical Center, Olive Branch, Mississippi, 38654, United States|Danny W. Jackson P.A., Rolling Fork, Mississippi, 39159, United States|Association Of International Professionals, Las Vegas, Nevada, 89101, United States|Physicians Research Center, Toms River, New Jersey, 08755, United States|Finger Lakes Clinical Research, Rochester, New York, 14618, United States|Metrolina Internal Medicine, Charlotte, North Carolina, 28204, United States|The Center For Nutrition & Preventive Medicine, Pllc, Charlotte, North Carolina, 28277, United States|Northstate Clinical Research, Lenoir, North Carolina, 28645, United States|New Hanover Medical Research, Wilmington, North Carolina, 28401, United States|Providence Health Partners - Center For Clinical Research, Dayton, Ohio, 45439, United States|Physician Research, Inc., Zanesville, Ohio, 43701, United States|Family Medical Associates, Levittown, Pennsylvania, 19056, United States|Banksville Medical, Pc, Pittsburgh, Pennsylvania, 15216, United States|Brookside Family Practice & Pediatrics, Pottstown, Pennsylvania, 19464, United States|Columbia Clinical Research, Inc., Columbia, South Carolina, 29201, United States|Southeastern Research Associates, Inc., Taylors, South Carolina, 29687, United States|Holston Medical Group, Kingsport, Tennessee, 37660, United States|Dallas Diabetes & Endocrine Center, Dallas, Texas, 75230, United States|Village Family Practice, Houston, Texas, 77024, United States|Office Of Dr. Michelle Zaniewski Singh, Houston, Texas, 77090, United States|Diabetes & Glandular Disease Research Assoc,, Inc., San Antonio, Texas, 78229, United States|Tidewater Integrated Medical Research, Virginia Beach, Virginia, 23454, United States|William L. Gray, Md, Spokane, Washington, 99216, United States|Local Institution, Ciudad Auton, Buenos Aires, C1408INH, Argentina|Local Institution, Zarate, Buenos Aires, 2800, Argentina|Local Institution, Buenos Aires, B1708IFF, Argentina|Local Institution, Cordoba, 5000, Argentina|Local Institution, Winnipeg, Manitoba, R3K 0Y8, Canada|Local Institution, Moncton, New Brunswick, E1G 1A7, Canada|Local Institution, Mount Pearl, Newfoundland and Labrador, A1N 1W7, Canada|Local Institution, Halifax, Nova Scotia, B3K 5R3, Canada|Local Institution, Sarnia, Ontario, N7T 4X3, Canada|Local Institution, Toronto, Ontario, M8V 3X8, Canada|Local Institution, Mirabel, Quebec, J7J 2K8, Canada|Local Institution, Hariyana, 132001, India|Local Institution, Mumbai, 400007, India|Local Institution, Vellore, 632004, India|Local Institution, Guadalajara, Jalisco, 44100, Mexico|Local Institution, Guadalajara, Jalisco, 44670, Mexico|Local Institution, Zapopan, Jalisco, 45200, Mexico|Local Institution, Monterrey, Nl, Nuevo Leon, 64400, Mexico|Local Institution, Monterrey, Nuevo Leon, 64240, Mexico|Local Institution, Merida, Yucatan, 97210, Mexico|Local Institution, Chihuahua, 31020, Mexico|Local Institution, Veracruz, 91700, Mexico|Local Institution, Lima, 09, Peru|Local Institution, Lima, 17, Peru|Local Institution, Lima, 31, Peru|Local Institution, Cebu City, 6000, Philippines|Local Institution, Manila, 1000, Philippines|Local Institution, Pasig City, 1600, Philippines|Local Institution, Ponce, 00717, Puerto Rico|Local Institution, Changhua, 500, Taiwan|Local Institution, Taichung, 43303, Taiwan|Local Institution, Taipei, 110, Taiwan |
| URL: | https://clinicaltrials.gov/show/NCT00683878 |
