A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas
Overview[ - collapse ][ - ]
| Purpose | The purpose of this trial is to understand if adding saxagliptin to a sulfonylurea is safe and works better than increasing the amount of sulfonylurea a patient takes |
|---|---|
| Condition | Diabetes |
| Intervention | Drug: Saxagliptin Drug: Saxagliptin Drug: Glyburide Drug: Placebo Drug: Glyburide Drug: Metformin |
| Phase | Phase 3 |
| Sponsor | Bristol-Myers Squibb |
| Responsible Party | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier | NCT00313313 |
| First Received | April 10, 2006 |
| Last Updated | August 4, 2010 |
| Last verified | June 2010 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 10, 2006 |
|---|---|
| Last Updated Date | August 4, 2010 |
| Start Date | April 2006 |
| Estimated Primary Completion Date | September 2008 |
| Current Primary Outcome Measures | Change From Baseline in Hemoglobin A1c (A1C) at Week 24 [Time Frame: Baseline, Week 24] [Designated as safety issue: No]Mean change from baseline in A1C at Week 24, adjusted for baseline value. |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas |
|---|---|
| Official Title | A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Glyburide in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Glyburide Alone |
| Brief Summary | The purpose of this trial is to understand if adding saxagliptin to a sulfonylurea is safe and works better than increasing the amount of sulfonylurea a patient takes |
| 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 (defined as rescue) will be eligible to enter the long-term treatment extension period where they will receive metformin.Rescue treatment with metformin is also available during the long-term extension period for subjects who meet glycemic criteria. |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
| Condition | Diabetes |
| Intervention | Drug: Saxagliptin Tablets, Oral, 2.5 mg, Daily AM, (24 weeks short-term [ST], 12 months long-term [LT]) Other Names: BMS-477118Drug: Saxagliptin Tablets, Oral, 5 mg, Daily AM (24 weeks ST, 12 months LT). Other Names: BMS-477118Drug: Glyburide Capsules, Oral, OL, 7.5 mg, Daily, AM (24 weeks ST, 12 months LT) Drug: Placebo Tablets, Oral, 0 mg, Daily AM/PM, (24 weeks ST, 12 months LT) Drug: Glyburide Capsules, Oral, DB Glyburide, 2.5 mg titrated to 7.5 mg + 7.5 mg OL, Daily AM/PM (24 weeks ST, 12 months LT) Drug: Metformin Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT) |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 768 |
| Estimated Completion Date | September 2008 |
| Estimated Primary Completion Date | September 2007 |
| Eligibility Criteria | Inclusion Criteria: - Type 2 Diabetes. - Treated with a sulfonylurea for at least 2 months. - Inadequate blood sugar control. - Are not on any other medications to lower blood sugar. - No major heart, liver or kidney problems. - Women not pregnant or breast feeding. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States, Argentina, Brazil, Hong Kong, Israel, Korea, Republic of, Mexico, Peru, Philippines, Puerto Rico, Singapore, South Africa, Taiwan |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00313313 |
|---|---|
| Other Study ID Numbers | CV181-040 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Bristol-Myers Squibb |
| Study Sponsor | Bristol-Myers Squibb |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | June 2010 |
Locations[ + expand ][ + ]
| Reserach Solutions, Llc | Jonesboro, Arkansas, United States, 72401 |
|---|---|
| Searcy Medical Center | Searcy, Arkansas, United States, 72143 |
| Stewart Medical Group | Alhambra, California, United States, 91801 |
| Southland Clinical Research Center, Inc. | Fountain Valley, California, United States, 92708 |
| Valley Research | Fresno, California, United States, 93720 |
| Randall Shue, D.O. | Los Angeles, California, United States, 90023 |
| Clinical Trials Research | Roseville, California, United States, 95661 |
| New West Physicians | Golden, Colorado, United States, 80401 |
| Phoenix Internal Medicine Associates, Llc | Waterbury, Connecticut, United States, 06708 |
| Christiana Care Research Institute | Newark, Delaware, United States, 19713 |
| Central Florida Clinical Trials | Altamonte Springs, Florida, United States, 32714 |
| Family Care Assoc & Emerald Care Res Grp | Chipley, Florida, United States, 32428 |
| Clinical Therapeutics Corporation | Coral Gables, Florida, United States, 33134 |
| Fpa Clinical Research | Kissimmee, Florida, United States, 34741 |
| Emerald Coast Research Group | Marianna, Florida, United States, 32446 |
| University Of Miami Diabetes Research Inst. | Miami, Florida, United States, 33136 |
| Atlanta Pharmaceutical Research Center, Inc | Dunwoody, Georgia, United States, 30338 |
| Cedar-Crosse Research Ctr | Chicago, Illinois, United States, 60607 |
| Family Medical Center Of Hart Co. | Munfordville, Kentucky, United States, 42765 |
| Columbia Medical Practice | Columbia, Maryland, United States, 21045 |
| Va Medical Center | Kansas City, Missouri, United States, 64128 |
| St. Louis Center For Clinical Research | St. Louis, Missouri, United States, 63128 |
| Nevada Alliance Against Diabetes | North Las Vegas, Nevada, United States, 89030 |
| Physicians Research Center | Toms River, New Jersey, United States, 08755 |
| Cny Family Care | East Syracuse, New York, United States, 13057 |
| Metrolina Internal Medicine | Charlotte, North Carolina, United States, 28204 |
| Med Res Assoc Charlotte | Charlotte, North Carolina, United States, 28211 |
| Regional Physicians Research | High Point, North Carolina, United States, 27262 |
| Diabetes & Endocrinology Consultants, Pc | Morehead City, North Carolina, United States, 28557 |
| Mountain Top Clinical Research Center | Sparta, North Carolina, United States, 28675 |
| Daystar Clinical Research, Inc. | Akron, Ohio, United States, 44313 |
| Community Health Care | Canal Fulton, Ohio, United States, 44614 |
| Triphase Research, Ltd. | Franklin, Ohio, United States, 45005 |
| Albert J Weisbrot,Md&Assoc Inc | Mason, Ohio, United States, 45040 |
| Dr Bahagwan Dass Md | Youngstown, Ohio, United States, 44507 |
| Oklahoma Cardiovascular And Hypertension Center | Oklahoma City, Oklahoma, United States, 73132 |
| Utica Park Clinic | Tulsa, Oklahoma, United States, 74104 |
| Integris Family Care Yukon | Yukon, Oklahoma, United States, 73109 |
| Coordinators Plus, Llc | Eugene, Oregon, United States, 97401 |
| Oregon Clinical Research | Portland, Oregon, United States, 97220 |
| Pearl Clinical Research | Norristown, Pennsylvania, United States, 19401 |
| Banksville Medical Pc | Pittsburgh, Pennsylvania, United States, 15216 |
| Guthrie Clinic, Ltd | Sayre, Pennsylvania, United States, 18840 |
| Upstate Pharmaceutical Research | Simsonville, South Carolina, United States, 29681 |
| Spartanburg Medical Research | Spartanburg, South Carolina, United States, 29303 |
| Southeastern Research Assoc | Taylors, South Carolina, United States, 29687 |
| Capital Medical Clinic, Llp | Austin, Texas, United States, 78705 |
| Texas Center For Drug Development, P.A. | Houston, Texas, United States, 77081 |
| Breath Of Life Research Institute | Katy, Texas, United States, 77450 |
| Diabetes & Glandular Disease Research Assoc, Pa | San Antonio, Texas, United States, 78229 |
| S.A.M. Clinical Research Center | San Antonio, Texas, United States, 78229 |
| Tidewater Integrated Medical Research | Virginia Beach, Virginia, United States, 23451 |
| Office Of Dr. Gray | Spokane, Washington, United States, 99216 |
| Advanced Healthcare S.C. | Milwaukee, Wisconsin, United States, 53209 |
| Local Institution | Mar Del Plata, Buenos Aires, Argentina, 7600 |
| Local Institution | Buenos Aires, Argentina, C1406FEQ |
| Local Institution | Buenos Aires, Argentina, C1425AGC |
| Local Institution | Cordoba, Argentina, 5000 |
| Local Institution | B. Rodolfo Teofilo, Ceara, Brazil, 60430 |
| Local Institution | Fortaleza, Ceara, Brazil, 60021 |
| Local Institution | Belo Horizonte, Minas Gerais, Brazil, 30150 |
| Local Institution | Belem, Para, Brazil, 66073 |
| Local Institution | Porto Alegre, Rio Grande Do Sul, Brazil, 90035003 |
| Local Institution | Porto Alegre, Rio Grande Do Sul, Brazil, 90610 |
| Local Institution | Campinas, Sao Paulo, Brazil, 13059 |
| Local Institution | Marília, Sao Paulo, Brazil, 17519 |
| Local Institution | Sao Paulo - Sp, Sao Paulo, Brazil, 04231 |
| Local Institution | Vila Mariana, Sao Paulo, Brazil, 04020 |
| Local Institution | Hong Kong, Hong Kong, SAR |
| Local Institution | Kowloon, Hong Kong |
| Local Institution | Givatayim, Israel, 53583 |
| Local Institution | Haifa, Israel, 31096 |
| Local Institution | Holon, Israel, 58100 |
| Local Institution | Jerusalem, Israel, 91120 |
| Local Institution | Rishon Le-Zion, Israel, 75650 |
| Local Institution | Tel Aviv, Israel, 64353 |
| Local Institution | Zefat, Israel, 13100 |
| Local Institution | Zerifin, Israel, 70300 |
| Local Institution | Kyunggi-Do, Korea, Republic of, 420-717 |
| Local Institution | Kyunggi-Do, Korea, Republic of, 463-707 |
| Local Institution | Seoul, Korea, Republic of, 137040 |
| Local Institution | Seoul, Korea, Republic of, 135-710 |
| Local Institution | Seoul, Korea, Republic of, 135-720 |
| Local Institution | Seoul, Korea, Republic of, 130-702 |
| Local Institution | Seoul, Korea, Republic of, 120-752 |
| Local Institution | Suwon, Korea, Republic of, 443721 |
| Local Institution | Tijuana, B.C., Baja California, Mexico, 22320 |
| Local Institution | Df, Distrito Federal, Mexico, 11800 |
| Local Institution | Guadalajara, Jalisco, Mexico, 44340 |
| Local Institution | Guadalajara, Jalisco, Mexico, 44670 |
| Local Institution | Cuernavaca, Morelos, Mexico, 62250 |
| Local Institution | Monterrey, Nuevo Leon, Mexico, 64710 |
| Local Institution | Monterrey, Nuevo Leon, Mexico, 64060 |
| Local Institution | Merida, Yucatan, Mexico, 97210 |
| Local Institution | Durango, Mexico, 64710 |
| Local Institution | San Isidro, Lima, Peru, 27 |
| Local Institution | Lima, Peru, LIMA 31 |
| Local Institution | Lima, Peru, LIMA 1 |
| Local Institution | Lima, Peru, 18 |
| Local Institution | Cebu, Philippines, 6000 |
| Local Institution | Manila, Philippines, 1000 |
| Local Institution | Quezon, Philippines, 1102 |
| Local Institution | Carolina, Puerto Rico, 00983 |
| Local Institution | Guaynabo, Puerto Rico, 00966 |
| Local Institution | Ponce, Puerto Rico, 00716 |
| Local Institution | Ponce, Puerto Rico, 00717 |
| Local Institution | Singapore, Singapore, 119074 |
| Local Institution | Umhlanga Rocks, Kwa Zulu Natal, South Africa, 4319 |
| Local Institution | Kimberley, Northern Cape, South Africa, 8301 |
| Local Institution | Tygerberg, Western Cape, South Africa, 7505 |
| Local Institution | Cape Town, South Africa, 7008 |
| Local Institution | Johannesburg, South Africa, 2196 |
| Local Institution | Changhua, Taiwan, 500 |
| Local Institution | Taichung, Taiwan, 402 |
| Local Institution | Taipei, Taiwan, 112 |