A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas
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
1 other identifier
interventional
768
13 countries
115
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 diabetes
Started Apr 2006
Longer than P75 for phase_3 diabetes
115 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 10, 2006
CompletedFirst Posted
Study publicly available on registry
April 12, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedResults Posted
Study results publicly available
September 25, 2009
CompletedMay 4, 2015
March 1, 2015
1.4 years
April 10, 2006
August 17, 2009
April 14, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Hemoglobin A1c (A1C) at Week 24
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Baseline, Week 24
Secondary Outcomes (3)
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Baseline, Week 24
Percentage of Participants Achieving A1C < 7% at Week 24
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
Baseline, Week 24
Study Arms (3)
Saxagliptin 2.5 mg + Glyburide 7.5 mg (A)
EXPERIMENTALMetformin 500-2500 mg (as needed)
Saxagliptin 5 mg + Glyburide 7.5 mg (B)
EXPERIMENTALMetformin 500-2500 mg (as needed)
Placebo + Glyburide 7.5 mg (C)
PLACEBO COMPARATORMetformin 500-2500 mg (as needed)
Interventions
Tablets, Oral, 2.5 mg, Daily AM, (24 weeks short-term \[ST\], 12 months long-term \[LT\])
Capsules, Oral, OL, 7.5 mg, Daily, AM (24 weeks ST, 12 months LT)
Tablets, Oral, 0 mg, Daily AM/PM, (24 weeks ST, 12 months LT)
Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT)
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (115)
Reserach Solutions, Llc
Jonesboro, Arkansas, 72401, United States
Searcy Medical Center
Searcy, Arkansas, 72143, United States
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
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
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
Family Medical Center Of Hart Co.
Munfordville, Kentucky, 42765, United States
Columbia Medical Practice
Columbia, Maryland, 21045, United States
Va Medical Center
Kansas City, Missouri, 64128, United States
St. Louis Center For Clinical Research
St Louis, Missouri, 63128, United States
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
Metrolina Internal Medicine
Charlotte, North Carolina, 28204, United States
Med Res Assoc Charlotte
Charlotte, North Carolina, 28211, 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
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
Pearl Clinical Research
Norristown, Pennsylvania, 19401, United States
Banksville Medical Pc
Pittsburgh, Pennsylvania, 15216, United States
Guthrie Clinic, Ltd
Sayre, Pennsylvania, 18840, United States
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
Advanced Healthcare S.C.
Milwaukee, Wisconsin, 53209, United States
Local Institution
Buenos Aires, Buenos Aires, C1406FEQ, Argentina
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Buenos Aires, Buenos Aires, C1425AGC, Argentina
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Mar del Plata, Buenos Aires, 7600, Argentina
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Córdoba, Córdoba Province, 5000, Argentina
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B. Rodolfo Teofilo, Ceará, 60430, Brazil
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Fortaleza, Ceará, 60021, Brazil
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Belo Horizonte, Minas Gerais, 30150, Brazil
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Belém, Pará, 66073, Brazil
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Porto Alegre, Rio Grande do Sul, 90035003, Brazil
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Porto Alegre, Rio Grande do Sul, 90610, Brazil
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Campinas, São Paulo, 13059, Brazil
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Marília, São Paulo, 17519, Brazil
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Sao Paulo - Sp, São Paulo, 04231, Brazil
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Vila Mariana, São Paulo, 04020, Brazil
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Hong Kong, SAR, Hong Kong
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Kowloon, Hong Kong
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Giv‘atayim, 53583, Israel
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Haifa, 31096, Israel
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Holon, 58100, Israel
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Jerusalem, 91120, Israel
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Rishon LeZiyyon, 75650, Israel
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Safed, 13100, Israel
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Tel Aviv, 64353, Israel
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Ẕerifin, 70300, Israel
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Durango, Durango, 64710, Mexico
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Tijuana, B.C., Estado de Baja California, 22320, Mexico
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Guadalajara, Jalisco, 44340, Mexico
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Guadalajara, Jalisco, 44670, Mexico
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Df, Mexico City, 11800, Mexico
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Cuernavaca, Morelos, 62250, Mexico
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Monterrey, Nuevo León, 64060, Mexico
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Monterrey, Nuevo León, 64710, Mexico
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Mérida, Yucatán, 97210, Mexico
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Lima, Lima Province, 18, Peru
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Lima, Lima Province, LIMA 1, Peru
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Lima, Lima Province, LIMA 31, Peru
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San Isidro, Lima region, 27, Peru
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Cebu, 6000, Philippines
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Manila, 1000, Philippines
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Quezon, 1102, Philippines
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Carolina, 00983, Puerto Rico
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Guaynabo, 00966, Puerto Rico
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Ponce, 00716, Puerto Rico
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Ponce, 00717, Puerto Rico
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Singapore, 119074, Singapore
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Umhlanga, KwaZulu-Natal, 4319, South Africa
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Kimberley, Northern Cape, 8301, South Africa
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Tygerberg, Western Cape, 7505, South Africa
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Cape Town, 7008, South Africa
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Johannesburg, 2196, South Africa
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Kyunggi-Do, 420-717, South Korea
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Kyunggi-Do, 463-707, South Korea
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Seoul, 120-752, South Korea
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Seoul, 130-702, South Korea
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Seoul, 135-710, South Korea
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Seoul, 135-720, South Korea
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Seoul, 137040, South Korea
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Suwon, 443721, South Korea
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Changhua, 500, Taiwan
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Taichung, 402, Taiwan
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Taipei, 112, Taiwan
Related Publications (6)
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.
PMID: 19614786BACKGROUNDPerl S, Cook W, Wei C, Iqbal N, Hirshberg B. Saxagliptin Efficacy and Safety in Patients With Type 2 Diabetes and Moderate Renal Impairment. Diabetes Ther. 2016 Sep;7(3):527-35. doi: 10.1007/s13300-016-0184-9. Epub 2016 Jul 11.
PMID: 27402391DERIVEDBonora E, Bryzinski B, Hirshberg B, Cook W. A post hoc analysis of saxagliptin efficacy and safety in patients with type 2 diabetes stratified by UKPDS 10-year cardiovascular risk score. Nutr Metab Cardiovasc Dis. 2016 May;26(5):374-9. doi: 10.1016/j.numecd.2015.11.004. Epub 2015 Dec 1.
PMID: 27033025DERIVEDKaryekar CS, Frederich R, Ravichandran S. Clinically relevant reductions in HbA1c without hypoglycaemia: results across four studies of saxagliptin. Int J Clin Pract. 2013 Aug;67(8):759-67. doi: 10.1111/ijcp.12212. Epub 2013 Jun 24.
PMID: 23795975DERIVEDKaryekar C, Donovan M, Allen E, Fleming D, Ravichandran S, Chen R. Efficacy and safety of saxagliptin combination therapy in US patients with type 2 diabetes. Postgrad Med. 2011 Jul;123(4):63-70. doi: 10.3810/pgm.2011.07.2305.
PMID: 21680990DERIVEDChacra AR, Tan GH, Ravichandran S, List J, Chen R; CV181040 Investigators. Safety and efficacy of saxagliptin in combination with submaximal sulphonylurea versus up-titrated sulphonylurea over 76 weeks. Diab Vasc Dis Res. 2011 Apr;8(2):150-9. doi: 10.1177/1479164111404574.
PMID: 21562067DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boaz Hirschberg
- Organization
- AstraZeneca Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2006
First Posted
April 12, 2006
Study Start
April 1, 2006
Primary Completion
September 1, 2007
Study Completion
September 1, 2008
Last Updated
May 4, 2015
Results First Posted
September 25, 2009
Record last verified: 2015-03