A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00313313
First received: April 10, 2006
Last updated: August 4, 2010
Last verified: June 2010
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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 | Intervention | Phase |
|---|---|---|
|
Diabetes |
Drug: Saxagliptin Drug: Glyburide Drug: Placebo Drug: Metformin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
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.
Secondary Outcome Measures:
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]Mean change from baseline in FPG at Week 24, adjusted for baseline value.
- Percentage of Participants Achieving A1C < 7% at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus glyburide versus placebo plus upward titrated glyburide at Week 24.
- Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline values.
| Enrollment: | 768 |
| Study Start Date: | April 2006 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Saxagliptin 2.5 mg + Glyburide 7.5 mg (A)
Metformin 500-2500 mg (as needed)
|
Drug: Saxagliptin
Tablets, Oral, 2.5 mg, Daily AM, (24 weeks short-term [ST], 12 months long-term [LT])
Other Name: BMS-477118
Drug: Glyburide
Capsules, Oral, OL, 7.5 mg, Daily, AM (24 weeks ST, 12 months LT)
Drug: Metformin
Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT)
|
|
Experimental: Saxagliptin 5 mg + Glyburide 7.5 mg (B)
Metformin 500-2500 mg (as needed)
|
Drug: Saxagliptin
Tablets, Oral, 5 mg, Daily AM (24 weeks ST, 12 months LT).
Other Name: BMS-477118
Drug: Glyburide
Capsules, Oral, OL, 7.5 mg, Daily, AM (24 weeks ST, 12 months LT)
Drug: Metformin
Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT)
|
|
Placebo Comparator: Placebo + Glyburide 7.5 mg (C)
Metformin 500-2500 mg (as needed)
|
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)
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 77 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00313313
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| United States, Arkansas | |
| Reserach Solutions, Llc | |
| Jonesboro, Arkansas, United States, 72401 | |
| Searcy Medical Center | |
| Searcy, Arkansas, United States, 72143 | |
| United States, California | |
| 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 | |
| United States, Colorado | |
| New West Physicians | |
| Golden, Colorado, United States, 80401 | |
| United States, Connecticut | |
| Phoenix Internal Medicine Associates, Llc | |
| Waterbury, Connecticut, United States, 06708 | |
| United States, Delaware | |
| Christiana Care Research Institute | |
| Newark, Delaware, United States, 19713 | |
| United States, Florida | |
| 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 | |
| United States, Georgia | |
| Atlanta Pharmaceutical Research Center, Inc | |
| Dunwoody, Georgia, United States, 30338 | |
| United States, Illinois | |
| Cedar-Crosse Research Ctr | |
| Chicago, Illinois, United States, 60607 | |
| United States, Kentucky | |
| Family Medical Center Of Hart Co. | |
| Munfordville, Kentucky, United States, 42765 | |
| United States, Maryland | |
| Columbia Medical Practice | |
| Columbia, Maryland, United States, 21045 | |
| United States, Missouri | |
| Va Medical Center | |
| Kansas City, Missouri, United States, 64128 | |
| St. Louis Center For Clinical Research | |
| St. Louis, Missouri, United States, 63128 | |
| United States, Nevada | |
| Nevada Alliance Against Diabetes | |
| North Las Vegas, Nevada, United States, 89030 | |
| United States, New Jersey | |
| Physicians Research Center | |
| Toms River, New Jersey, United States, 08755 | |
| United States, New York | |
| Cny Family Care | |
| East Syracuse, New York, United States, 13057 | |
| United States, North Carolina | |
| 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 | |
| United States, Ohio | |
| 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 | |
| United States, Oklahoma | |
| 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 | |
| United States, Oregon | |
| Coordinators Plus, Llc | |
| Eugene, Oregon, United States, 97401 | |
| Oregon Clinical Research | |
| Portland, Oregon, United States, 97220 | |
| United States, Pennsylvania | |
| Pearl Clinical Research | |
| Norristown, Pennsylvania, United States, 19401 | |
| Banksville Medical Pc | |
| Pittsburgh, Pennsylvania, United States, 15216 | |
| Guthrie Clinic, Ltd | |
| Sayre, Pennsylvania, United States, 18840 | |
| United States, South Carolina | |
| 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 | |
| United States, Texas | |
| 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 | |
| United States, Virginia | |
| Tidewater Integrated Medical Research | |
| Virginia Beach, Virginia, United States, 23451 | |
| United States, Washington | |
| Office Of Dr. Gray | |
| Spokane, Washington, United States, 99216 | |
| United States, Wisconsin | |
| Advanced Healthcare S.C. | |
| Milwaukee, Wisconsin, United States, 53209 | |
| Argentina | |
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| Mar Del Plata, Buenos Aires, Argentina, 7600 | |
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| Buenos Aires, Argentina, C1406FEQ | |
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| Buenos Aires, Argentina, C1425AGC | |
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| Cordoba, Argentina, 5000 | |
| Brazil | |
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| B. Rodolfo Teofilo, Ceara, Brazil, 60430 | |
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| Fortaleza, Ceara, Brazil, 60021 | |
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| Belo Horizonte, Minas Gerais, Brazil, 30150 | |
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| Belem, Para, Brazil, 66073 | |
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| Porto Alegre, Rio Grande Do Sul, Brazil, 90035003 | |
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| Porto Alegre, Rio Grande Do Sul, Brazil, 90610 | |
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| Campinas, Sao Paulo, Brazil, 13059 | |
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| Marília, Sao Paulo, Brazil, 17519 | |
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| Sao Paulo - Sp, Sao Paulo, Brazil, 04231 | |
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| Vila Mariana, Sao Paulo, Brazil, 04020 | |
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| Hong Kong, Hong Kong, SAR | |
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| Kowloon, Hong Kong | |
| Israel | |
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| Givatayim, Israel, 53583 | |
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| Haifa, Israel, 31096 | |
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| Holon, Israel, 58100 | |
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| Jerusalem, Israel, 91120 | |
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| Rishon Le-Zion, Israel, 75650 | |
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| Tel Aviv, Israel, 64353 | |
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| Zefat, Israel, 13100 | |
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| Zerifin, Israel, 70300 | |
| Korea, Republic of | |
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| Kyunggi-Do, Korea, Republic of, 420-717 | |
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| Kyunggi-Do, Korea, Republic of, 463-707 | |
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| Seoul, Korea, Republic of, 137040 | |
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| Seoul, Korea, Republic of, 135-710 | |
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| Seoul, Korea, Republic of, 135-720 | |
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| Seoul, Korea, Republic of, 130-702 | |
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| Seoul, Korea, Republic of, 120-752 | |
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| Suwon, Korea, Republic of, 443721 | |
| Mexico | |
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| Tijuana, B.C., Baja California, Mexico, 22320 | |
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| Df, Distrito Federal, Mexico, 11800 | |
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| Guadalajara, Jalisco, Mexico, 44340 | |
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| Guadalajara, Jalisco, Mexico, 44670 | |
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| Cuernavaca, Morelos, Mexico, 62250 | |
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| Monterrey, Nuevo Leon, Mexico, 64710 | |
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| Monterrey, Nuevo Leon, Mexico, 64060 | |
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| Merida, Yucatan, Mexico, 97210 | |
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| Durango, Mexico, 64710 | |
| Peru | |
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| San Isidro, Lima, Peru, 27 | |
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| Lima, Peru, LIMA 31 | |
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| Lima, Peru, LIMA 1 | |
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| Lima, Peru, 18 | |
| Philippines | |
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| Cebu, Philippines, 6000 | |
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| Manila, Philippines, 1000 | |
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| Quezon, Philippines, 1102 | |
| Puerto Rico | |
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| Carolina, Puerto Rico, 00983 | |
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| Guaynabo, Puerto Rico, 00966 | |
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| Ponce, Puerto Rico, 00716 | |
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| Ponce, Puerto Rico, 00717 | |
| Singapore | |
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| Singapore, Singapore, 119074 | |
| South Africa | |
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| Umhlanga Rocks, Kwa Zulu Natal, South Africa, 4319 | |
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| Kimberley, Northern Cape, South Africa, 8301 | |
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| Tygerberg, Western Cape, South Africa, 7505 | |
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| Cape Town, South Africa, 7008 | |
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| Johannesburg, South Africa, 2196 | |
| Taiwan | |
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| Changhua, Taiwan, 500 | |
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| Taichung, Taiwan, 402 | |
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| Taipei, Taiwan, 112 | |
Sponsors and Collaborators
Bristol-Myers Squibb
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00313313 History of Changes |
| Other Study ID Numbers: | CV181-040 |
| Study First Received: | April 10, 2006 |
| Results First Received: | August 17, 2009 |
| Last Updated: | August 4, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Saxagliptin Glyburide Metformin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013