Study of Dapagliflozin in Combination With Metformin XR to Initiate the Treatment of Type 2 Diabetes
Overview[ - collapse ][ - ]
Purpose | The primary purpose of this study is to compare the change from baseline in hemoglobin A1C achieved with dapagliflozin 10 mg in combination with metformin XR as compared with metformin monotherapy and compared with Dapagliflozin monotherapy, after 24 weeks of oral administration of double-blind treatment. The safety of treatment with dapagliflozin will also be assessed in this study |
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Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: Dapagliflozin Drug: Metformin XR Drug: Metformin XR Drug: dapagliflozin matching Placebo Drug: metformin HCl Modified Release matching Placebo |
Phase | Phase 3 |
Sponsor | Bristol-Myers Squibb |
Responsible Party | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier | NCT00859898 |
First Received | March 10, 2009 |
Last Updated | February 4, 2014 |
Last verified | February 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | March 10, 2009 |
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Last Updated Date | February 4, 2014 |
Start Date | April 2009 |
Estimated Primary Completion Date | May 2010 |
Current Primary Outcome Measures | Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 (Last Observation Carried Forward) - Randomized Treated Participants [Time Frame: Week 24] [Designated as safety issue: No]Adjusted mean change in HbA1c from baseline at Week 24 (or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available, ie, last observation carried forward (LOCF) was determined. 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. |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Study of Dapagliflozin in Combination With Metformin XR to Initiate the Treatment of Type 2 Diabetes |
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Official Title | A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin 10 mg in Combination With Metformin as Initial Therapy as Compared With Dapagliflozin 10 mg Monotherapy and Metformin Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control |
Brief Summary | The primary purpose of this study is to compare the change from baseline in hemoglobin A1C achieved with dapagliflozin 10 mg in combination with metformin XR as compared with metformin monotherapy and compared with Dapagliflozin monotherapy, after 24 weeks of oral administration of double-blind treatment. The safety of treatment with dapagliflozin will also be assessed in this study |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: Dapagliflozin Tablets, Oral, 10 mg, once daily, 24 weeks Other Names: Farxiga™Drug: Metformin XR Tablets, Oral, up to 2000 mg, once daily, 24 weeks Other Names: Glucophage®Drug: Metformin XR Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks Other Names: Glucophage®Drug: dapagliflozin matching Placebo Drug: metformin HCl Modified Release matching Placebo |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 1093 |
Estimated Completion Date | May 2010 |
Estimated Primary Completion Date | May 2010 |
Eligibility Criteria | Inclusion Criteria: - Treatment naive males and females, >= 18 years old and <= 77 years old, with type 2 diabetes mellitus - Subjects must have central laboratory pre-randomization hemoglobin A1C >= 7.5 and <= 12.0% - C-peptide >= 1.0 ng/mL (0.34 nmol/L) - Body Mass Index <= 45 kg/m2 - Must be able to perform self monitoring of blood glucose Exclusion Criteria: - aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3X*upper limit of normal (ULN) - Serum Total bilirubin >2 mg/dL (34.2 µmol/L) - Creatinine kinase >3*ULN - Serum creatinine >= 1.50 mg/dL (133 µmol/L) for male subjects, >= 1.40 mg/dL (124 µmol/L) for female subjects - Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States, India, Korea, Republic of, Mexico, Puerto Rico, Russian Federation |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00859898 |
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Other Study ID Numbers | MB102-034 |
Has Data Monitoring Committee | No |
Information Provided By | Bristol-Myers Squibb |
Study Sponsor | Bristol-Myers Squibb |
Collaborators | AstraZeneca |
Investigators | Study Director: Bristol-Myers Squibb Bristol-Myers Squibb |
Verification Date | February 2014 |
Locations[ + expand ][ + ]
International Institute Of Clinical Research | Ozark, Alabama, United States, 36360 |
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Clinical Research Advantage, Inc. | Tempe, Arizona, United States, 85282 |
Clinical Research Advantage, Inc./Mesa Family Med Ctr, Pc | Tempe, Arizona, United States, 85282 |
John Muir Physician Network Clinical Research Center | Concord, California, United States, 94520 |
Encompass Clinical Research-North Coast | Encinitas, California, United States, 92024 |
Southland Clinical Research Center, Inc. | Fountain Valley, California, United States, 92708 |
Valley Research | Fresno, California, United States, 93720 |
Del Rosario Medical Clinic, Inc. | Huntington Park, California, United States, 90255 |
Irvine Center For Clinical Research, Inc. | Irvine, California, United States, 92618 |
Pacific Sleep Medicine Services (Avastra Clinical Trials) | Redlands, California, United States, 92373 |
Orange County Research Center | Tustin, California, United States, 92780 |
Lynn Institute Of The Rockies | Colorado Springs, Colorado, United States, 80907 |
Radiant Research, Inc. | Denver, Colorado, United States, 80239 |
Clinical Therapeutics Corporation | Coral Gables, Florida, United States, 33134 |
Nextphase Clinical Trials, Inc. | Miami, Florida, United States, 33145 |
Baptist Diabetes Associates | Miami, Florida, United States, 33156 |
Metabolic Research Institute, Inc. | W Palm Beach, Florida, United States, 33401 |
Lake Hartwell Family Medicine | Hartwell, Georgia, United States, 30643 |
Middle Georgia Drug Study Center, Llc | Perry, Georgia, United States, 31069 |
Northwest Clinical Trials | Boise, Idaho, United States, 83704 |
Provident Clinical Research | Addison, Illinois, United States, 60101 |
Cedar Crosse Research Center | Chicago, Illinois, United States, 60607 |
Deerbrook Medical Associates | Vernon Hills, Illinois, United States, 60061 |
Physicians Research Group | Indianapolis, Indiana, United States, 46250 |
Borgess Research Institute | Kalamazoo, Michigan, United States, 49048 |
Olive Branch Family Medical Center | Olive Branch, Mississippi, United States, 38654 |
Clinilabs, Inc. | New York, New York, United States, 10019 |
Metrolina Medical Research | Charlotte, North Carolina, United States, 28209 |
Pharmquest | Greensboro, North Carolina, United States, 27408 |
Crescent Medical Research | Salisbury, North Carolina, United States, 28144 |
Community Health Care, Inc. | Canal Fulton, Ohio, United States, 44614 |
Holzer Clinic, Inc | Gallipolis, Ohio, United States, 45631 |
Wells Institute For Health Awareness | Kettering, Ohio, United States, 45429 |
Newark Physician Associates | Newark, Ohio, United States, 43055 |
Daniel G. Williams, Md | Perrysburg, Ohio, United States, 43551 |
Physician Research, Inc. | Zanesville, Ohio, United States, 43701 |
Gilbert Medical Research, Llc | Bethany, Oklahoma, United States, 73008 |
Tulsa Clinical Research, Llc | Tulsa, Oklahoma, United States, 74104 |
Integris Family Care Yukon | Yukon, Oklahoma, United States, 73099 |
Williamette Valley Clinical Studies | Eugene, Oregon, United States, 97404 |
Dingmans Medical | Dingmans Ferry, Pennsylvania, United States, 18328 |
Integrated Medical Group Pc/Fleetwood Clinical Research | Fleetwood, Pennsylvania, United States, 19522 |
Wellmon Family Practice | Shippensburg, Pennsylvania, United States, 17257 |
Safe Harbor Clinical Research | E. Providence, Rhode Island, United States, 02914 |
Southeastern Research Associates, Inc. | Greenville, South Carolina, United States, 29605 |
Holston Medical Group | Bristol, Tennessee, United States, 37620 |
Parkway Medical Group | Fayetteville, Tennessee, United States, 37334 |
Holston Medical Group | Kingsport, Tennessee, United States, 37660 |
Southwind Medical Specialists | Memphis, Tennessee, United States, 38125 |
Dallas Diabetes & Endocrine Center | Dallas, Texas, United States, 75230 |
Non-Invasive Cardiovascular, Pa | Houston, Texas, United States, 77074 |
Endocrine Associates | Houston, Texas, United States, 77004 |
Texas Center For Drug Development | Houston, Texas, United States, 77081 |
Excel Clinical Research | Houston, Texas, United States, 77081 |
Juno Research, Llc. | Houston, Texas, United States, 77036 |
Village Family Practice | Houston, Texas, United States, 77024 |
Midland Clinical Research Center | Midland, Texas, United States, 79707 |
Hill Country Medical Associates | New Braunfels, Texas, United States, 78130 |
Covenant Clinical Research, Pa | San Antonio, Texas, United States, 78229 |
S.A.M. Clinical Research Center | San Antonio, Texas, United States, 78229 |
Avastra Clinical Trials | Midvale, Utah, United States, 84047 |
Seven Corners Medical Center | Falls Church, Virginia, United States, 22044 |
Tidewater Integrated Medical Research | Virginia Beach, Virginia, United States, 23454 |
Northwest Clinical Research Center | Bellevue, Washington, United States, 98007 |
Local Institution | Hyderabad, Andhra Pradesh, India, 500034 |
Local Institution | Aminjikarai, Chennai, India, 600029 |
Local Institution | Haryana, Karnal, India, 132001 |
Local Institution | Bangalore, Karnataka, India, 560054 |
Local Institution | Indore, Madhya Pradesh, India, 452010 |
Local Institution | Nagpur, Maharashtra, India, 440010 |
Local Institution | Nagpur, Maharashtra, India, 440012 |
Local Institution | Chennai, Tamilnadu, India, 600020 |
Local Institution | Ghaziabad, Uttar Pradesh, India, 201002 |
Local Institution | Jaipur, India, 302001 |
Local Institution | Bucheon, Gyeonggi-Do, Korea, Republic of, 420-717 |
Local Institution | Goyang-Si, Gyeonggi-Do, Korea, Republic of, 410773 |
Local Institution | Guri-Si, Gyeonggi-Do, Korea, Republic of, 471-701 |
Local Institution | Sungnam, Gyeonggi-Do, Korea, Republic of, 463-070 |
Local Institution | Daegu, Korea, Republic of, 700-721 |
Local Institution | Incheon, Korea, Republic of, 405-760 |
Local Institution | Seoul, Korea, Republic of, 137040 |
Local Institution | Guadalajara, Jalisco, Mexico, 44100 |
Local Institution | Guadalajara, Jalisco, Mexico, CP 44650 |
Local Institution | Guadalajara, Jalisco, Mexico, CP 44670 |
Local Institution | Morelia, Michioacan, Mexico, 58070 |
Local Institution | Cuernavaca, Morelos, Mexico, 62448 |
Local Institution | Monterrey, Nuevo Leon, Mexico, 64000 |
Local Institution | Monterrey, Nuevo Leon, Mexico, 64460 |
Local Institution | Merida, Yucatan, Mexico, 97070 |
Local Institution | Aguascalientes, Mexico, 20230 |
Local Institution | Durango, Mexico, 34000 |
Local Institution | Veracruz, Mexico, CP 91910 |
Local Institution | Fajardo, Puerto Rico, 00738 |
Local Institution | Ponce, Puerto Rico, 00717 |
Local Institution | Ponce, Puerto Rico, 00716 |
Local Institution | San Juan, Puerto Rico, 00926 |
Local Institution | San Juan, Puerto Rico, 00909 |
Local Institution | San Juan, Puerto Rico, 00920 |
Local Institution | Ekaterinaburg, Russian Federation, 620043 |
Local Institution | Kemerovo, Russian Federation, 650029 |
Local Institution | Krasnoyarsk, Russian Federation, 660022 |
Local Institution | Moscov, Russian Federation, 119048 |
Local Institution | Moscow, Russian Federation, 140091 |
Local Institution | Moscow, Russian Federation, 125299 |
Local Institution | Moscow, Russian Federation, 105229 |
Local Institution | Nizhniy Novgorod, Russian Federation, 603018 |
Local Institution | Nizhniy Novgorod, Russian Federation, 603126 |
Local Institution | Novosibirsk, Russian Federation, 630091 |
Local Institution | Novosibirsk, Russian Federation, 630117 |
Local Institution | Saint Petersburg, Russian Federation, 194044 |
Local Institution | Saint-Petersburg, Russian Federation, 190068 |
Local Institution | Samara, Russian Federation, 443067 |
Local Institution | Saratov, Russian Federation, 410028 |
Local Institution | Smolensk, Russian Federation, 214018 |
Local Institution | St. Petersburg, Russian Federation, 193312 |
Local Institution | St. Petersburg, Russian Federation, 191015 |
Local Institution | St.Petersburg, Russian Federation, 191186 |
Local Institution | Tyumen, Russian Federation, 625023 |
Local Institution | Vladimir, Russian Federation, 600023 |
Local Institution | Volgograd, Russian Federation, 400001 |
Local Institution | Voronezh, Russian Federation, 394018 |
Local Institution | Yaroslavl, Russian Federation, 150003 |
Local Institution | Yaroslavl, Russian Federation, 150023 |