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

NCT ID: NCT00313313

Last Updated: 2015-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 768 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2008-09-30

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Saxagliptin 2.5 mg + Glyburide 7.5 mg (A)

Metformin 500-2500 mg (as needed)

Group Type: EXPERIMENTAL

Saxagliptin

Intervention Type: DRUG

Tablets, Oral, 2.5 mg, Daily AM, (24 weeks short-term \[ST\], 12 months long-term \[LT\])

Glyburide

Intervention Type: DRUG

Capsules, Oral, OL, 7.5 mg, Daily, AM (24 weeks ST, 12 months LT)

Metformin

Intervention Type: DRUG

Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT)

Saxagliptin 5 mg + Glyburide 7.5 mg (B)

Metformin 500-2500 mg (as needed)

Group Type: EXPERIMENTAL

Saxagliptin

Intervention Type: DRUG

Tablets, Oral, 5 mg, Daily AM (24 weeks ST, 12 months LT).

Glyburide

Intervention Type: DRUG

Capsules, Oral, OL, 7.5 mg, Daily, AM (24 weeks ST, 12 months LT)

Metformin

Intervention Type: DRUG

Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT)

Placebo + Glyburide 7.5 mg (C)

Metformin 500-2500 mg (as needed)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Tablets, Oral, 0 mg, Daily AM/PM, (24 weeks ST, 12 months LT)

Glyburide

Intervention Type: DRUG

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)

Metformin

Intervention Type: DRUG

Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT)

Interventions

Saxagliptin

Tablets, Oral, 2.5 mg, Daily AM, (24 weeks short-term \[ST\], 12 months long-term \[LT\])

Intervention Type: DRUG

Saxagliptin

Tablets, Oral, 5 mg, Daily AM (24 weeks ST, 12 months LT).

Intervention Type: DRUG

Glyburide

Capsules, Oral, OL, 7.5 mg, Daily, AM (24 weeks ST, 12 months LT)

Intervention Type: DRUG

Placebo

Tablets, Oral, 0 mg, Daily AM/PM, (24 weeks ST, 12 months LT)

Intervention Type: 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)

Intervention Type: DRUG

Metformin

Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT)

Intervention Type: DRUG

Other Intervention Names

BMS-477118; BMS-477118

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 77 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Reserach Solutions, Llc

Jonesboro, Arkansas, United States

Searcy Medical Center

Searcy, Arkansas, United States

Stewart Medical Group

Alhambra, California, United States

Southland Clinical Research Center, Inc.

Fountain Valley, California, United States

Valley Research

Fresno, California, United States

Randall Shue, D.O.

Los Angeles, California, United States

Clinical Trials Research

Roseville, California, United States

New West Physicians

Golden, Colorado, United States

Phoenix Internal Medicine Associates, Llc

Waterbury, Connecticut, United States

Christiana Care Research Institute

Newark, Delaware, United States

Central Florida Clinical Trials

Altamonte Springs, Florida, United States

Family Care Assoc & Emerald Care Res Grp

Chipley, Florida, United States

Clinical Therapeutics Corporation

Coral Gables, Florida, United States

Fpa Clinical Research

Kissimmee, Florida, United States

Emerald Coast Research Group

Marianna, Florida, United States

University Of Miami Diabetes Research Inst.

Miami, Florida, United States

Atlanta Pharmaceutical Research Center, Inc

Dunwoody, Georgia, United States

Cedar-Crosse Research Ctr

Chicago, Illinois, United States

Family Medical Center Of Hart Co.

Munfordville, Kentucky, United States

Columbia Medical Practice

Columbia, Maryland, United States

Va Medical Center

Kansas City, Missouri, United States

St. Louis Center For Clinical Research

St Louis, Missouri, United States

Nevada Alliance Against Diabetes

North Las Vegas, Nevada, United States

Physicians Research Center

Toms River, New Jersey, United States

Cny Family Care

East Syracuse, New York, United States

Metrolina Internal Medicine

Charlotte, North Carolina, United States

Med Res Assoc Charlotte

Charlotte, North Carolina, United States

Regional Physicians Research

High Point, North Carolina, United States

Diabetes & Endocrinology Consultants, Pc

Morehead City, North Carolina, United States

Mountain Top Clinical Research Center

Sparta, North Carolina, United States

Daystar Clinical Research, Inc.

Akron, Ohio, United States

Community Health Care

Canal Fulton, Ohio, United States

Triphase Research, Ltd.

Franklin, Ohio, United States

Albert J Weisbrot,Md&Assoc Inc

Mason, Ohio, United States

Dr Bahagwan Dass Md

Youngstown, Ohio, United States

Oklahoma Cardiovascular And Hypertension Center

Oklahoma City, Oklahoma, United States

Utica Park Clinic

Tulsa, Oklahoma, United States

Integris Family Care Yukon

Yukon, Oklahoma, United States

Coordinators Plus, Llc

Eugene, Oregon, United States

Oregon Clinical Research

Portland, Oregon, United States

Pearl Clinical Research

Norristown, Pennsylvania, United States

Banksville Medical Pc

Pittsburgh, Pennsylvania, United States

Guthrie Clinic, Ltd

Sayre, Pennsylvania, United States

Upstate Pharmaceutical Research

Simsonville, South Carolina, United States

Spartanburg Medical Research

Spartanburg, South Carolina, United States

Southeastern Research Assoc

Taylors, South Carolina, United States

Capital Medical Clinic, Llp

Austin, Texas, United States

Texas Center For Drug Development, P.A.

Houston, Texas, United States

Breath Of Life Research Institute

Katy, Texas, United States

Diabetes & Glandular Disease Research Assoc, Pa

San Antonio, Texas, United States

S.A.M. Clinical Research Center

San Antonio, Texas, United States

Tidewater Integrated Medical Research

Virginia Beach, Virginia, United States

Office Of Dr. Gray

Spokane, Washington, United States

Advanced Healthcare S.C.

Milwaukee, Wisconsin, United States

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Buenos Aires, Buenos Aires, Argentina

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Mar del Plata, Buenos Aires, Argentina

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Córdoba, Córdoba Province, Argentina

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B. Rodolfo Teofilo, Ceará, Brazil

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Fortaleza, Ceará, Brazil

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Belo Horizonte, Minas Gerais, Brazil

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Belém, Pará, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Campinas, São Paulo, Brazil

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Marília, São Paulo, Brazil

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Sao Paulo - Sp, São Paulo, Brazil

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Vila Mariana, São Paulo, Brazil

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Hong Kong, , Hong Kong

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Kowloon, , Hong Kong

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Giv‘atayim, , Israel

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Haifa, , Israel

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Holon, , Israel

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Jerusalem, , Israel

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Rishon LeZiyyon, , Israel

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Safed, , Israel

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Tel Aviv, , Israel

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Ẕerifin, , Israel

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Durango, Durango, Mexico

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Tijuana, B.C., Estado de Baja California, Mexico

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Guadalajara, Jalisco, Mexico

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Guadalajara, Jalisco, Mexico

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Df, Mexico City, Mexico

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Cuernavaca, Morelos, Mexico

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Monterrey, Nuevo León, Mexico

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Monterrey, Nuevo León, Mexico

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Mérida, Yucatán, Mexico

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Lima, Lima Province, Peru

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Lima, Lima Province, Peru

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Lima, Lima Province, Peru

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San Isidro, Lima region, Peru

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Cebu, , Philippines

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Manila, , Philippines

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Quezon, , Philippines

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Carolina, , Puerto Rico

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Guaynabo, , Puerto Rico

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Ponce, , Puerto Rico

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Ponce, , Puerto Rico

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Singapore, , Singapore

Local Institution

Umhlanga, KwaZulu-Natal, South Africa

Local Institution

Kimberley, Northern Cape, South Africa

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Tygerberg, Western Cape, South Africa

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Cape Town, , South Africa

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Johannesburg, , South Africa

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Kyunggi-Do, , South Korea

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Kyunggi-Do, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Suwon, , South Korea

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Changhua, , Taiwan

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Taichung, , Taiwan

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Taipei, , Taiwan

Countries

United States; Argentina; Brazil; Hong Kong; Israel; Mexico; Peru; Philippines; Puerto Rico; Singapore; South Africa; South Korea; Taiwan

References

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.

Reference Type: BACKGROUND

PMID: 19614786 (View on PubMed)

Perl 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.

Reference Type: DERIVED

PMID: 27402391 (View on PubMed)

Bonora 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.

Reference Type: DERIVED

PMID: 27033025 (View on PubMed)

Karyekar 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.

Reference Type: DERIVED

PMID: 23795975 (View on PubMed)

Karyekar 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.

Reference Type: DERIVED

PMID: 21680990 (View on PubMed)

Chacra 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.

Reference Type: DERIVED

PMID: 21562067 (View on PubMed)

Other Identifiers

CV181-040

Identifier Type: -

Identifier Source: org_study_id