Study of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
Overview[ - collapse ][ - ]
Purpose | The purpose of this trial is to understand if saxagliptin is more effective than placebo as a treatment for type 2 diabetic subjects who are not controlled with diet and exercise |
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Condition | Diabetes |
Intervention | Drug: Saxagliptin Drug: Saxagliptin Drug: Saxagliptin Drug: Saxagliptin Drug: Placebo Drug: metformin |
Phase | Phase 3 |
Sponsor | Bristol-Myers Squibb |
Responsible Party | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier | NCT00316082 |
First Received | April 18, 2006 |
Last Updated | November 20, 2009 |
Last verified | November 2009 |
Tracking Information[ + expand ][ + ]
First Received Date | April 18, 2006 |
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Last Updated Date | November 20, 2009 |
Start Date | June 2006 |
Estimated Primary Completion Date | November 2008 |
Current Primary Outcome Measures | Change From Baseline in Hemoglobin A1 (A1C) at Week 24 [Time Frame: Baseline, Week 24] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Study of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise |
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Official Title | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise |
Brief Summary | The purpose of this trial is to understand if saxagliptin is more effective than placebo as a treatment for type 2 diabetic subjects who are not controlled with diet and exercise |
Detailed Description | All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive metformin (rescue medication) added onto their blinded study medication |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition | Diabetes |
Intervention | Drug: Saxagliptin Coated tablets, Oral, 2.5 mg, QAM, Daily (6 months ST, 12 months LT) Other Names: BMS-477118Drug: Saxagliptin Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT) Other Names: BMS-477118Drug: Saxagliptin Coated tablets, Oral, 5mg, QAM, Daily, (6 months ST, 12 months LT) Other Names: BMS-477118Drug: Saxagliptin Coated tablets, Oral, 5mg QPM, Daily (6 months ST, 12 months LT) Other Names: BMS-477118Drug: Placebo Coated tablets, Oral, 0mg, Daily (6 months ST, 12 months LT) Drug: metformin Tablets, Oral, 500-2000 mg, as needed (12 months LT) |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 365 |
Estimated Completion Date | November 2008 |
Estimated Primary Completion Date | November 2007 |
Eligibility Criteria | Inclusion Criteria: - Type 2 diabetes - Inadequate blood sugar control Exclusion Criteria: - Previous treatment for diabetes - Current treatment with other medications to lower blood sugar - Major heart, liver or kidney problems - Women who are pregnant or breastfeeding |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States, India, Russian Federation, Taiwan |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00316082 |
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Other Study ID Numbers | CV181-038 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | Bristol-Myers Squibb |
Study Sponsor | Bristol-Myers Squibb |
Collaborators | Not Provided |
Investigators | Study Director: Bristol-Myers Squibb Bristol-Myers Squibb |
Verification Date | November 2009 |
Locations[ + expand ][ + ]
Tomac, Inc. | Columbiana, Alabama, United States, 35051 |
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Winston Technology, Inc. | Haleyville, Alabama, United States, 35565 |
Clinical Reseacrh Advantage/ Brown Family Medicine | Mesa, Arizona, United States, 85213 |
Strategos Medical Group | Bakersfield, California, United States, 93311 |
Providence Clinical Research | Burbank, California, United States, 91505 |
Rx For Life, Inc | Cudahy, California, United States, 90201 |
Medical Group Of Encino | Encino, California, United States, 91436 |
Southland Clinical Research Center, Inc. | Fountain Valley, California, United States, 92708 |
Valley Research | Fresno, California, United States, 93720 |
Diabetes Medical Center Of California | Northridge, California, United States, 91325 |
In Private Prictice Clinic | Pico Rivera, California, United States, 90660 |
San Jose Clinical Research, Inc. | San Jose, California, United States, 95128 |
Central Florida Clinical Trials, Inc. | Altamonte Springs, Florida, United States, 32714 |
Accelovance | Melbourne, Florida, United States, 32935 |
University Family Healthcare, Pa | Sarasota, Florida, United States, 34243 |
Premier Healthcare | St. Petersburg, Florida, United States, 33707 |
Pinnacle Medical Research | Overland Park, Kansas, United States, 66215 |
Kansas City University Of Medicine And Biosciences | Kansas City, Missouri, United States, 64106 |
Primary Care Physicians, Pc | Wentzville, Missouri, United States, 63385 |
Physicians Research Center | Toms River, New Jersey, United States, 08755 |
Hudson Valley Clinical Research Center | Kingston, New York, United States, 12401 |
Neem Research Group Of Charlotte | Charlotte, North Carolina, United States, 28262 |
Diabetes Center- East Carolina University | Greenville, North Carolina, United States, 27834 |
Crescent Medical Research | Salisbury, North Carolina, United States, 28144 |
Community Health Care, Inc. | Barberton, Ohio, United States, 44203 |
Clinical Research Limited | Canton, Ohio, United States, 44718 |
Wells Institute For Health Awareness | Kettering, Ohio, United States, 45429 |
Clinical Research Source, Inc | Perrysburg, Ohio, United States, 43551 |
Accelovance | Oklahoma City, Oklahoma, United States, 73112 |
Integris Family Care South | Oklahoma City, Oklahoma, United States, 73170 |
The Office Of Patricia Buchanan | Eugene, Oregon, United States, 97404 |
Cumberland Valley Endocrinology Center, Llc | Carlisle, Pennsylvania, United States, 17015 |
Fleetwood Clinical Research | Fleetwood, Pennsylvania, United States, 19522 |
Banksville Medical, Pc | Pittsburgh, Pennsylvania, United States, 15216 |
Biomedical Research Associates, Llc | Shippensburg, Pennsylvania, United States, 17257 |
Middle Tyger Family Medicine | Duncan, South Carolina, United States, 29334 |
Southeastern Research Assoc | Taylors, South Carolina, United States, 29687 |
Versoza & Ungab Internal Medicine Associates | Bartlett, Tennessee, United States, 38134 |
Collierville Medical Specialist | Collierville, Tennessee, United States, 38017 |
Holston Medical Group | Kingsport, Tennessee, United States, 37660 |
Southwind Medical Specialist | Memphis, Tennessee, United States, 38125 |
Med-South Research | Memphis, Tennessee, United States, 38116 |
Precision Family Medicine | Carrollton, Texas, United States, 75010 |
Alpha Therapy Research Center | Corpus Christi, Texas, United States, 78411 |
Village Family Practice | Houston, Texas, United States, 77024 |
Texas Center For Drug Development, P.A. | Houston, Texas, United States, 77081 |
Abbott Clinical Research Group, Inc | San Antonio, Texas, United States, 78224 |
Taylor/Wade Medical | Bountiful, Utah, United States, 84010 |
Optimum Clinical Research | Salt Lake City, Utah, United States, 84102 |
Tidewater Integrated Medical Research | Virginia Beach, Virginia, United States, 23451 |
Spokane Internal Medicine | Spokane, Washington, United States, 99216 |
Local Institution | Manipal, Karnataka, India, 576104 |
Local Institution | Kochi, Kerala, India, 682026 |
Local Institution | Attavar, Mangalore, India, 575001 |
Local Institution | Sarita Vihar, New Delhi, India, 110076 |
Local Institution | Bangalore, India, 560034 |
Local Institution | Mumbai, India, 400007 |
Local Institution | Mumbai, India, 400021 |
Local Institution | Nagpur, India, 440012 |
Local Institution | Moscov, Russian Federation, 118089 |
Local Institution | Moscow, Russian Federation, 115487 |
Local Institution | Nizhniy Novgorod, Russian Federation, 603126 |
Local Institution | Saint Petersburg, Russian Federation, 198013 |
Local Institution | Saratov, Russian Federation, 410018 |
Local Institution | Saratov, Russian Federation, 410054 |
Local Institution | Smolensk, Russian Federation, 214018 |
Local Institution | St.Petersburg, Russian Federation, 194156 |
Local Institution | Volgograd, Russian Federation, 400138 |
Local Institution | Changhua, Taiwan, 500 |
Local Institution | Kaohsiung County, Taiwan, 833 |
Local Institution | Taichung, Taiwan, 402 |
Local Institution | Taichung City, Taiwan, 407 |
Local Institution | Taipei City, Taiwan, 114 |
Local Institution | Tao-Yuan County, Taiwan, 333 |