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A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes

Intervention: Saxagliptin (Drug); Saxagliptin (Drug); Glyburide (Drug); Placebo (Drug); Glyburide (Drug); Metformin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change From Baseline in Hemoglobin A1c (A1C) at Week 24

Secondary outcome:

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

Percentage of Participants Achieving A1C < 7% 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

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

Minimum age: 18 Years. Maximum age: 77 Years. Gender(s): Both.

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.

Locations and Contacts

Local Institution, Buenos Aires C1406FEQ, Argentina

Local Institution, Buenos Aires C1425AGC, Argentina

Local Institution, Cordoba 5000, Argentina

Local Institution, Hong Kong SAR, Hong Kong

Local Institution, Kowloon, Hong Kong

Local Institution, Givatayim 53583, Israel

Local Institution, Haifa 31096, Israel

Local Institution, Holon 58100, Israel

Local Institution, Jerusalem 91120, Israel

Local Institution, Rishon Le-Zion 75650, Israel

Local Institution, Tel Aviv 64353, Israel

Local Institution, Zefat 13100, Israel

Local Institution, Zerifin 70300, Israel

Local Institution, Kyunggi-Do 420-717, Korea, Republic of

Local Institution, Kyunggi-Do 463-707, Korea, Republic of

Local Institution, Seoul 130-702, Korea, Republic of

Local Institution, Seoul 135-710, Korea, Republic of

Local Institution, Seoul 135-720, Korea, Republic of

Local Institution, Seoul 137040, Korea, Republic of

Local Institution, Seoul 120-752, Korea, Republic of

Local Institution, Suwon 443721, Korea, Republic of

Local Institution, Durango 64710, Mexico

Local Institution, Lima 18, Peru

Local Institution, Lima LIMA 1, Peru

Local Institution, Lima LIMA 31, Peru

Local Institution, Cebu 6000, Philippines

Local Institution, Manila 1000, Philippines

Local Institution, Quezon 1102, Philippines

Local Institution, Carolina 00983, Puerto Rico

Local Institution, Guaynabo 00966, Puerto Rico

Local Institution, Ponce 00716, Puerto Rico

Local Institution, Ponce 00717, Puerto Rico

Local Institution, Singapore 119074, Singapore

Local Institution, Cape Town 7008, South Africa

Local Institution, Johannesburg 2196, South Africa

Local Institution, Changhua 500, Taiwan

Local Institution, Taichung 402, Taiwan

Local Institution, Taipei 112, Taiwan

Reserach Solutions, Llc, Jonesboro, Arkansas 72401, United States

Searcy Medical Center, Searcy, Arkansas 72143, United States

Local Institution, Tijuana, B.C., Baja California 22320, Mexico

Local Institution, Mar Del Plata, Buenos Aires 7600, Argentina

Stewart Medical Group, Alhambra, California 91801, United States

Southland Clinical Research Center, Inc., Fountain Valley, California 92708, United States

Valley Research, Fresno, California 93720, United States

Randall Shue, D.O., Los Angeles, California 90023, United States

Clinical Trials Research, Roseville, California 95661, United States

Local Institution, B. Rodolfo Teofilo, Ceara 60430, Brazil

Local Institution, Fortaleza, Ceara 60021, Brazil

New West Physicians, Golden, Colorado 80401, United States

Phoenix Internal Medicine Associates, Llc, Waterbury, Connecticut 06708, United States

Christiana Care Research Institute, Newark, Delaware 19713, United States

Local Institution, Df, Distrito Federal 11800, Mexico

Central Florida Clinical Trials, Altamonte Springs, Florida 32714, United States

Family Care Assoc & Emerald Care Res Grp, Chipley, Florida 32428, United States

Clinical Therapeutics Corporation, Coral Gables, Florida 33134, United States

Fpa Clinical Research, Kissimmee, Florida 34741, United States

Emerald Coast Research Group, Marianna, Florida 32446, United States

University Of Miami Diabetes Research Inst., Miami, Florida 33136, United States

Atlanta Pharmaceutical Research Center, Inc, Dunwoody, Georgia 30338, United States

Cedar-Crosse Research Ctr, Chicago, Illinois 60607, United States

Local Institution, Guadalajara, Jalisco 44670, Mexico

Local Institution, Guadalajara, Jalisco 44340, Mexico

Family Medical Center Of Hart Co., Munfordville, Kentucky 42765, United States

Local Institution, Umhlanga Rocks, Kwa Zulu Natal 4319, South Africa

Local Institution, San Isidro, Lima 27, Peru

Columbia Medical Practice, Columbia, Maryland 21045, United States

Local Institution, Belo Horizonte, Minas Gerais 30150, Brazil

Va Medical Center, Kansas City, Missouri 64128, United States

St. Louis Center For Clinical Research, St. Louis, Missouri 63128, United States

Local Institution, Cuernavaca, Morelos 62250, Mexico

Nevada Alliance Against Diabetes, North Las Vegas, Nevada 89030, United States

Physicians Research Center, Toms River, New Jersey 08755, United States

Cny Family Care, East Syracuse, New York 13057, United States

Med Res Assoc Charlotte, Charlotte, North Carolina 28211, United States

Metrolina Internal Medicine, Charlotte, North Carolina 28204, United States

Regional Physicians Research, High Point, North Carolina 27262, United States

Diabetes & Endocrinology Consultants, Pc, Morehead City, North Carolina 28557, United States

Mountain Top Clinical Research Center, Sparta, North Carolina 28675, United States

Local Institution, Kimberley, Northern Cape 8301, South Africa

Local Institution, Monterrey, Nuevo Leon 64060, Mexico

Local Institution, Monterrey, Nuevo Leon 64710, Mexico

Daystar Clinical Research, Inc., Akron, Ohio 44313, United States

Community Health Care, Canal Fulton, Ohio 44614, United States

Triphase Research, Ltd., Franklin, Ohio 45005, United States

Albert J Weisbrot,Md&Assoc Inc, Mason, Ohio 45040, United States

Dr Bahagwan Dass Md, Youngstown, Ohio 44507, United States

Oklahoma Cardiovascular And Hypertension Center, Oklahoma City, Oklahoma 73132, United States

Utica Park Clinic, Tulsa, Oklahoma 74104, United States

Integris Family Care Yukon, Yukon, Oklahoma 73109, United States

Coordinators Plus, Llc, Eugene, Oregon 97401, United States

Oregon Clinical Research, Portland, Oregon 97220, United States

Local Institution, Belem, Para 66073, Brazil

Pearl Clinical Research, Norristown, Pennsylvania 19401, United States

Banksville Medical Pc, Pittsburgh, Pennsylvania 15216, United States

Guthrie Clinic, Ltd, Sayre, Pennsylvania 18840, United States

Local Institution, Porto Alegre, Rio Grande Do Sul 90035003, Brazil

Local Institution, Porto Alegre, Rio Grande Do Sul 90610, Brazil

Local Institution, Campinas, Sao Paulo 13059, Brazil

Local Institution, MarĂ­lia, Sao Paulo 17519, Brazil

Local Institution, Sao Paulo - Sp, Sao Paulo 04231, Brazil

Local Institution, Vila Mariana, Sao Paulo 04020, Brazil

Upstate Pharmaceutical Research, Simsonville, South Carolina 29681, United States

Spartanburg Medical Research, Spartanburg, South Carolina 29303, United States

Southeastern Research Assoc, Taylors, South Carolina 29687, United States

Capital Medical Clinic, Llp, Austin, Texas 78705, United States

Texas Center For Drug Development, P.A., Houston, Texas 77081, United States

Breath Of Life Research Institute, Katy, Texas 77450, United States

Diabetes & Glandular Disease Research Assoc, Pa, San Antonio, Texas 78229, United States

S.A.M. Clinical Research Center, San Antonio, Texas 78229, United States

Tidewater Integrated Medical Research, Virginia Beach, Virginia 23451, United States

Office Of Dr. Gray, Spokane, Washington 99216, United States

Local Institution, Tygerberg, Western Cape 7505, South Africa

Advanced Healthcare S.C., Milwaukee, Wisconsin 53209, United States

Local Institution, Merida, Yucatan 97210, Mexico

Additional Information

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Related publications:

Chacra AR, Tan GH, Apanovitch A, Ravichandran S, List J, Chen R; CV181-040 Investigators. Saxagliptin added to a submaximal dose of sulphonylurea improves glycaemic control compared with uptitration of sulphonylurea in patients with type 2 diabetes: a randomised controlled trial. Int J Clin Pract. 2009 Sep;63(9):1395-406. doi: 10.1111/j.1742-1241.2009.02143.x. Epub 2009 Jul 15. Erratum in: Int J Clin Pract. 2010 Jan;64(2):277.

Starting date: April 2006
Last updated: April 14, 2015

Page last updated: August 23, 2015

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