Rosiglitazone Versus a Sulfonylurea On Progression Of Atherosclerosis In Patients With Heart Disease And Type 2 Diabetes

NCT ID: NCT00116831

Last Updated: 2017-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 672 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2008-08-31

Brief Summary

The purpose of this study is to test the safety and effectiveness of rosiglitazone against a sulfonylurea in reducing or slowing the development of atherosclerosis in the blood vessels of the heart.

Conditions

Atherosclerosis

Study Design

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

Study Groups

Glipizide

oral anti-diabetic medication

Group Type: ACTIVE_COMPARATOR

Glipizide

Intervention Type: DRUG

oral anti-diabetic medication

rosiglitazone maleate

oral anti-diabetic medication

Group Type: EXPERIMENTAL

rosiglitazone maleate

Intervention Type: DRUG

oral antidiabetic medication

Interventions

Glipizide

oral anti-diabetic medication

Intervention Type: DRUG

rosiglitazone maleate

oral antidiabetic medication

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female between 30 to 80 years of age, inclusive.
• Established diagnosis of T2DM (based on diagnostic criteria of the American Diabetes Association (ADA), WHO guidelines or local national guidelines).
• Subjects who are undergoing coronary angiography for evaluation of suspected or previously diagnosed coronary artery disease or who are undergoing PCI.
• Subjects' prior anti-hyperglycemic diabetic therapy:

Diet and exercise only (drug naïve), with HbA1c >7.0 and £ 10.0%. HbA1c > 6.5 and <= 8.5%.

• Left ventricular ejection fraction (EF) ³ 40% as assessed by contrast ventriculography (or previously documented in medical notes within one month prior to index procedure by other methods e.g. echocardiography or nuclear study)
• Female subjects must be postmenopausal (i.e., >6 months without menstrual period), surgically sterile, or using effective contraceptive measures (oral contraceptives, Norplant, Depo-Provera, an intra-uterine device (IUD), a diaphragm with spermicide or a condom with spermicide). Women of childbearing potential must use effective contraceptive measures for at least 1 month prior to visit 1a, and should continue to use the same contraceptive method during the study and for 30 days after discontinuing study medication.
• Willingness and ability to give informed consent prior to entering the study and available to complete the study.

Exclusion Criteria

• Type 1 diabetes and/or history of diabetic ketoacidosis.
• Exposure to a TZD or other PPAR-g agonist within the 6 months prior to screening visit.
• Subjects treated with triple OAD therapy or high dose dual combination OAD therapy [1].
• Subjects who have required chronic insulin use in the last 6 months (except during pregnancy or acute episodes such as hospitalization, trauma or infection).
• ST segment elevation myocardial infarction in the last 30 days.
• Subjects who have a history or are scheduled to receive coronary artery bypass graft surgery (CABG), valve repair or replacement, aneurysmectomy or planned major non-cardiac surgery during the study period.
• Subjects who have severe cardiac valvular disease
• Stroke or resuscitated in the past 6 months
• History of congestive heart failure (NYHA class I - IV)
• History of significant hypersensitivity or reaction (e.g., difficulty swallowing, difficulty breathing, tachycardia or skin reaction) to any TZD, SU, biguanide or insulin
• Prior history of severe edema or edema requiring medical treatment.
• Chronic disease requiring chronic or intermittent treatment with oral, intravenous, or injected corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible).
• Recent history or suspicion of current drug abuse or alcohol abuse within the last 6 months.
• Untreated hypo- or hyperthyroidism
• A diagnosis of cancer (other than superficial squamous, basal cell skin cancer, or adequately treated cervical carcinoma in situ) in the past 3 years or current treatment for the active cancer.
• Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgement of the Investigator, would preclude safe completion of the study.
• Blood pressure: SBP >170 or DBP > 100 mmHg
• Significant anemia (Hemoglobin < 11 g/dL for males and < 10 g/dL for females).
• Significant renal disease manifested by serum creatinine (> 1.5mg/dL for males or > 1.4mg/dL for females), or where the use of metformin is contra-indicated.
• Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 2.5 times upper limit of normal (ULN) or bilirubin >2x ULN).
• History of myopathy or history of elevated creatine kinase (CK) > 3 times upper normal limit.
• Use of an investigational drug within 30 days or 5 half-lives (whichever is the longer).
• Women who are lactating, pregnant or planning to become pregnant during the course of the study.
• Unwillingness or inability to comply with the procedures described in this protocol.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Scottsdale, Arizona, United States

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

Burbank, California, United States

GSK Investigational Site

Huntington Beach, California, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

Mission Viejo, California, United States

GSK Investigational Site

Sacramento, California, United States

GSK Investigational Site

Sacramento, California, United States

GSK Investigational Site

Torrance, California, United States

GSK Investigational Site

Torrance, California, United States

GSK Investigational Site

Denver, Colorado, United States

GSK Investigational Site

Englewood, Colorado, United States

GSK Investigational Site

Washington D.C., District of Columbia, United States

GSK Investigational Site

Melbourne, Florida, United States

GSK Investigational Site

Tampa, Florida, United States

GSK Investigational Site

Atlanta, Georgia, United States

GSK Investigational Site

Peoria, Illinois, United States

GSK Investigational Site

Springfield, Illinois, United States

GSK Investigational Site

Indianapolis, Indiana, United States

GSK Investigational Site

Baltimore, Maryland, United States

GSK Investigational Site

Columbia, Maryland, United States

GSK Investigational Site

Springfield, Massachusetts, United States

GSK Investigational Site

Springfield, Missouri, United States

GSK Investigational Site

New Brunswick, New Jersey, United States

GSK Investigational Site

Albany, New York, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

Winston-Salem, North Carolina, United States

GSK Investigational Site

Winston-Salem, North Carolina, United States

GSK Investigational Site

Canton, Ohio, United States

GSK Investigational Site

Beaver, Pennsylvania, United States

GSK Investigational Site

Camp Hill, Pennsylvania, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Jackson, Tennessee, United States

GSK Investigational Site

Corpus Christi, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Bellevue, Washington, United States

GSK Investigational Site

Milwaukee, Wisconsin, United States

GSK Investigational Site

Capital Federal, Buenos Aires, Argentina

GSK Investigational Site

Capital Federal, Buenos Aires, Argentina

GSK Investigational Site

Capital Federal, Buenos Aires, Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

GSK Investigational Site

Munro, Buenos Aires, Argentina

GSK Investigational Site

San Justo, Buenos Aires, Argentina

GSK Investigational Site

San Martín, Buenos Aires, Argentina

GSK Investigational Site

Córdoba, Córdoba Province, Argentina

GSK Investigational Site

Buenos Aires, , Argentina

GSK Investigational Site

Buenos Aires, , Argentina

GSK Investigational Site

Buenos Aires, , Argentina

GSK Investigational Site

Buenos Aires, , Argentina

GSK Investigational Site

Buenos Aires, , Argentina

GSK Investigational Site

Córdoba, , Argentina

GSK Investigational Site

Moron-Provincia de Buenos Aires, , Argentina

GSK Investigational Site

Ribeirão Preto, São Paulo, Brazil

GSK Investigational Site

São Paulo, São Paulo, Brazil

GSK Investigational Site

São Paulo, São Paulo, Brazil

GSK Investigational Site

São Paulo, São Paulo, Brazil

GSK Investigational Site

Hamilton, Ontario, Canada

GSK Investigational Site

London, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Montreal, Quebec, Canada

GSK Investigational Site

Hradec Králové, , Czechia

GSK Investigational Site

Corbeil-Essonnes, , France

GSK Investigational Site

Le Plessis-Robinson, , France

GSK Investigational Site

Marseille, , France

GSK Investigational Site

Rennes, , France

GSK Investigational Site

Heidelberg, Baden-Wurttemberg, Germany

GSK Investigational Site

Heidelberg, Baden-Wurttemberg, Germany

GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Coburg, Bavaria, Germany

GSK Investigational Site

Kronach, Bavaria, Germany

GSK Investigational Site

Kulmbach, Bavaria, Germany

GSK Investigational Site

Lichtenfels, Bavaria, Germany

GSK Investigational Site

Hirschhorn, Hesse, Germany

GSK Investigational Site

Lampertheim, Hesse, Germany

GSK Investigational Site

Bochum, North Rhine-Westphalia, Germany

GSK Investigational Site

Dinslaken, North Rhine-Westphalia, Germany

GSK Investigational Site

Dormagen, North Rhine-Westphalia, Germany

GSK Investigational Site

Dortmund, North Rhine-Westphalia, Germany

GSK Investigational Site

Dortmund, North Rhine-Westphalia, Germany

GSK Investigational Site

Dortmund, North Rhine-Westphalia, Germany

GSK Investigational Site

Duisburg, North Rhine-Westphalia, Germany

GSK Investigational Site

Düsseldorf, North Rhine-Westphalia, Germany

GSK Investigational Site

Essen, North Rhine-Westphalia, Germany

GSK Investigational Site

Essen, North Rhine-Westphalia, Germany

GSK Investigational Site

Essen, North Rhine-Westphalia, Germany

GSK Investigational Site

Essen, North Rhine-Westphalia, Germany

GSK Investigational Site

Essen, North Rhine-Westphalia, Germany

GSK Investigational Site

Essen, North Rhine-Westphalia, Germany

GSK Investigational Site

Gelsenkirchen, North Rhine-Westphalia, Germany

GSK Investigational Site

Herne, North Rhine-Westphalia, Germany

GSK Investigational Site

Herne, North Rhine-Westphalia, Germany

GSK Investigational Site

Leverkusen, North Rhine-Westphalia, Germany

GSK Investigational Site

Lünen, North Rhine-Westphalia, Germany

GSK Investigational Site

Marl, North Rhine-Westphalia, Germany

GSK Investigational Site

Oberhausen, North Rhine-Westphalia, Germany

GSK Investigational Site

Ludwigshafen am Rhein, Rhineland-Palatinate, Germany

GSK Investigational Site

Rhaunen, Rhineland-Palatinate, Germany

GSK Investigational Site

Speyer, Rhineland-Palatinate, Germany

GSK Investigational Site

Trier, Rhineland-Palatinate, Germany

GSK Investigational Site

Trier, Rhineland-Palatinate, Germany

GSK Investigational Site

Friedrichsthal, Saarland, Germany

GSK Investigational Site

Saarlouis, Saarland, Germany

GSK Investigational Site

Sr. Ingbert, Saarland, Germany

GSK Investigational Site

Athens, , Greece

GSK Investigational Site

Athens, , Greece

GSK Investigational Site

Athens, , Greece

GSK Investigational Site

Athens, , Greece

GSK Investigational Site

Causeway Bay, , Hong Kong

GSK Investigational Site

Kowloon, , Hong Kong

GSK Investigational Site

Kwun Tong, , Hong Kong

GSK Investigational Site

Pokfulam, , Hong Kong

GSK Investigational Site

Shatin, , Hong Kong

GSK Investigational Site

Mumbai, , India

GSK Investigational Site

New Delhi, , India

GSK Investigational Site

Udine, Friuli Venezia Giulia, Italy

GSK Investigational Site

Rozzano (Mi), Lombardy, Italy

GSK Investigational Site

Riga, , Latvia

GSK Investigational Site

Guadalajara, Jalisco, Mexico

GSK Investigational Site

Monterrey, Nuevo León, Mexico

GSK Investigational Site

Breda, , Netherlands

GSK Investigational Site

Eindhoven, , Netherlands

GSK Investigational Site

Enschede, , Netherlands

GSK Investigational Site

Nieuwegein, , Netherlands

GSK Investigational Site

Rotterdam, , Netherlands

GSK Investigational Site

Rotterdam, , Netherlands

GSK Investigational Site

Zwolle, , Netherlands

GSK Investigational Site

Bialystok, , Poland

GSK Investigational Site

Kalisz, , Poland

GSK Investigational Site

Katowice, , Poland

GSK Investigational Site

Poznan, , Poland

GSK Investigational Site

Warsaw, , Poland

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Suwon, , South Korea

GSK Investigational Site

Alicante, , Spain

GSK Investigational Site

Badalona, , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Marid, , Spain

GSK Investigational Site

Málaga, , Spain

GSK Investigational Site

Murcia, , Spain

GSK Investigational Site

Oviedo, , Spain

GSK Investigational Site

San Juan/Alicante, , Spain

GSK Investigational Site

Gothenburg, , Sweden

GSK Investigational Site

Stockholm, , Sweden

GSK Investigational Site

Bangkok, , Thailand

GSK Investigational Site

Chiang Mai, , Thailand

Countries

United States; Argentina; Brazil; Canada; Czechia; France; Germany; Greece; Hong Kong; India; Italy; Latvia; Mexico; Netherlands; Poland; Russia; South Korea; Spain; Sweden; Thailand

References

Garcia-Garcia HM, Garg S, Brugaletta S, Morocutti G, Ratner RE, Kolatkar NS, Kravitz BG, Miller DM, Huang C, Nesto RW, Serruys PW; APPROACH study group. Evaluation of in-stent restenosis in the APPROACH trial (Assessment on the Prevention of Progression by Rosiglitazone On Atherosclerosis in diabetes patients with Cardiovascular History). Int J Cardiovasc Imaging. 2012 Mar;28(3):455-65. doi: 10.1007/s10554-011-9836-z. Epub 2011 Feb 27.

Reference Type: BACKGROUND

PMID: 21359834 (View on PubMed)

Gerstein HC, Ratner RE, Cannon CP, Serruys PW, García-García HM, van Es G-A, Kolatkar NS, Kravitz BG, Miller DM, Huang C, Fitzgerald PJ, Nesto RW; APPROACH study group. Effect of Rosiglitazone on Progression of Coronary Atherosclerosis in Patients with Type 2 Diabetes and Coronary Artery Disease: The APPROACH trial. (Submitted for publication).

Reference Type: BACKGROUND

Nesto RW. Effect of rosiglitazone versus glipizide on progression of coronary atherosclerosis in patients with type 2 diabetes and coronary artery disease. American Heart Association Scientific Sessions. November 12, 2008, New Orleans, LA. (http://directnews.americanheart.org/extras/pdfs/approach_slides.pdf)

Reference Type: BACKGROUND

Ratner RE, Cannon CP, Gerstein HC, Nesto RW, Serruys PW, Van Es GA, Kolatkar NS, Kravitz BG, Zalewski A, Fitzgerald PJ; APPROACH Study Group. Assessment on the Prevention of Progression by Rosiglitazone on Atherosclerosis in diabetes patients with Cardiovascular History (APPROACH): study design and baseline characteristics. Am Heart J. 2008 Dec;156(6):1074-9. doi: 10.1016/j.ahj.2008.07.025. Epub 2008 Oct 11.

Reference Type: BACKGROUND

PMID: 19033001 (View on PubMed)

Gerstein HC, Ratner RE, Cannon CP, Serruys PW, Garcia-Garcia HM, van Es GA, Kolatkar NS, Kravitz BG, Miller DM, Huang C, Fitzgerald PJ, Nesto RW; APPROACH Study Group. Effect of rosiglitazone on progression of coronary atherosclerosis in patients with type 2 diabetes mellitus and coronary artery disease: the assessment on the prevention of progression by rosiglitazone on atherosclerosis in diabetes patients with cardiovascular history trial. Circulation. 2010 Mar 16;121(10):1176-87. doi: 10.1161/CIRCULATIONAHA.109.881003. Epub 2010 Mar 1.

Reference Type: DERIVED

PMID: 20194881 (View on PubMed)

Study Documents

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

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Other Identifiers

AVD100521

Identifier Type: -

Identifier Source: org_study_id