AzTrials
AzTrials

AtherosclerosisPhase 3NCT00116831

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

A Phase 3 study testing Glipizide and rosiglitazone maleate in people with Atherosclerosis, run by GlaxoSmithKline at 156 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Atherosclerosis
What is being tested?
Glipizide and rosiglitazone maleate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
672 participants
Where
156 sitesin 20 countries
Study dates
Jan 2005to Aug 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

156 sites in 20 countries.

156 sites in 20 countries

United States39 sites

  • GSK Investigational Site

    Albany, New York, 12208

  • GSK Investigational Site

    Atlanta, Georgia, 30309

  • GSK Investigational Site

    Baltimore, Maryland, 21287

  • GSK Investigational Site

    Beaver, Pennsylvania, 15009

  • GSK Investigational Site

    Bellevue, Washington, 98004

  • GSK Investigational Site

    Birmingham, Alabama, 35235

  • GSK Investigational Site

    Burbank, California, 91505

  • GSK Investigational Site

    Camp Hill, Pennsylvania, 17011

  • GSK Investigational Site

    Canton, Ohio, 44708

  • GSK Investigational Site

    Columbia, Maryland, 21044

  • GSK Investigational Site

    Corpus Christi, Texas, 78404

  • GSK Investigational Site

    Denver, Colorado, 80220

  • GSK Investigational Site

    Englewood, Colorado, 80113

  • GSK Investigational Site

    Huntington Beach, California, 92648

  • GSK Investigational Site

    Indianapolis, Indiana, 46260

  • GSK Investigational Site

    Jackson, Tennessee, 38301

  • GSK Investigational Site

    Los Angeles, California, 90017

  • GSK Investigational Site

    Melbourne, Florida, 32901

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53215

  • GSK Investigational Site

    Mission Viejo, California, 92691

  • GSK Investigational Site

    New Brunswick, New Jersey, 08903

  • GSK Investigational Site

    New York, New York, 10032

  • GSK Investigational Site

    Peoria, Illinois, 61615

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19141

  • GSK Investigational Site

    Sacramento, California, 95817

  • GSK Investigational Site

    Sacramento, California, 95825

  • GSK Investigational Site

    San Antonio, Texas, 78207

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    Scottsdale, Arizona, 85251

  • GSK Investigational Site

    Springfield, Illinois, 62702

  • GSK Investigational Site

    Springfield, Massachusetts, 01199

  • GSK Investigational Site

    Springfield, Missouri, 65807

  • GSK Investigational Site

    Tampa, Florida, 33609

  • GSK Investigational Site

    Torrance, California, 90503

  • GSK Investigational Site

    Torrance, California, 90509

  • GSK Investigational Site

    Tucson, Arizona, 85745

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20010

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27157

Other trials in United States

Germany38 sites

  • GSK Investigational Site

    Bochum, North Rhine-Westphalia, 44789

  • GSK Investigational Site

    Coburg, Bavaria, 96450

  • GSK Investigational Site

    Dinslaken, North Rhine-Westphalia, 46537

  • GSK Investigational Site

    Dormagen, North Rhine-Westphalia, 41539

  • GSK Investigational Site

    Dortmund, North Rhine-Westphalia, 44137

  • GSK Investigational Site

    Dortmund, North Rhine-Westphalia, 44328

  • GSK Investigational Site

    Dortmund, North Rhine-Westphalia, 44339

  • GSK Investigational Site

    Duisburg, North Rhine-Westphalia, 47119

  • GSK Investigational Site

    Düsseldorf, North Rhine-Westphalia, 40454

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45122

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45136

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45309

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45329

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45355

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45359

  • GSK Investigational Site

    Friedrichsthal, Saarland, 66299

  • GSK Investigational Site

    Gelsenkirchen, North Rhine-Westphalia, 45881

  • GSK Investigational Site

    Heidelberg, Baden-Wurttemberg, 69120

  • GSK Investigational Site

    Heidelberg, Baden-Wurttemberg, 69126

  • GSK Investigational Site

    Herne, North Rhine-Westphalia, 44623

  • GSK Investigational Site

    Herne, North Rhine-Westphalia, 44653

  • GSK Investigational Site

    Hirschhorn, Hesse, 69434

  • GSK Investigational Site

    Kronach, Bavaria, 96317

  • GSK Investigational Site

    Kulmbach, Bavaria, 95326

  • GSK Investigational Site

    Lampertheim, Hesse, 68623

  • GSK Investigational Site

    Leverkusen, North Rhine-Westphalia, 51377

  • GSK Investigational Site

    Lichtenfels, Bavaria, 96215

  • GSK Investigational Site

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67063

  • GSK Investigational Site

    Lünen, North Rhine-Westphalia, 44534

  • GSK Investigational Site

    Mannheim, Baden-Wurttemberg, 68161

  • GSK Investigational Site

    Marl, North Rhine-Westphalia, 45772

  • GSK Investigational Site

    Oberhausen, North Rhine-Westphalia, 46049

  • GSK Investigational Site

    Rhaunen, Rhineland-Palatinate, 55624

  • GSK Investigational Site

    Saarlouis, Saarland, 66740

  • GSK Investigational Site

    Speyer, Rhineland-Palatinate, 67346

  • GSK Investigational Site

    Sr. Ingbert, Saarland, 66386

  • GSK Investigational Site

    Trier, Rhineland-Palatinate, 54292

  • GSK Investigational Site

    Trier, Rhineland-Palatinate, 54296

Other trials in Germany

Argentina15 sites

  • GSK Investigational Site

    Buenos Aires, 1221

  • GSK Investigational Site

    Buenos Aires, 1405

  • GSK Investigational Site

    Buenos Aires, 1416

  • GSK Investigational Site

    Buenos Aires, 1428

  • GSK Investigational Site

    Buenos Aires, C1416DRW

  • GSK Investigational Site

    Capital Federal, Buenos Aires, 1181

  • GSK Investigational Site

    Capital Federal, Buenos Aires, C1155ADP

  • GSK Investigational Site

    Capital Federal, Buenos Aires, C1437JCP

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, B1704ETD

  • GSK Investigational Site

    Córdoba, Córdoba Province, 5000

  • GSK Investigational Site

    Córdoba, 5000

  • GSK Investigational Site

    Moron-Provincia de Buenos Aires, 1709

  • GSK Investigational Site

    Munro, Buenos Aires, 1605

  • GSK Investigational Site

    San Justo, Buenos Aires, B7118XAB

  • GSK Investigational Site

    San Martín, Buenos Aires, 1650

Other trials in Argentina

Spain11 sites

  • GSK Investigational Site

    Alicante, 03010

  • GSK Investigational Site

    Badalona, 08916

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    Barcelona, 08097

  • GSK Investigational Site

    Madrid, 28035

  • GSK Investigational Site

    Málaga, 29010

  • GSK Investigational Site

    Marid, 28040

  • GSK Investigational Site

    Murcia, 30120

  • GSK Investigational Site

    Oviedo, 33006

  • GSK Investigational Site

    San Juan/Alicante, 03550

Other trials in Spain

Netherlands7 sites

  • GSK Investigational Site

    Breda, 4818 CK

  • GSK Investigational Site

    Eindhoven, 5623 EJ

  • GSK Investigational Site

    Enschede, 7511JX

  • GSK Investigational Site

    Nieuwegein, 3435 CM

  • GSK Investigational Site

    Rotterdam, 3015 GD

  • GSK Investigational Site

    Rotterdam, 3075 EA

  • GSK Investigational Site

    Zwolle, 8011 JW

Other trials in Netherlands

Canada5 sites

  • GSK Investigational Site

    Hamilton, Ontario, L8L 2X2

  • GSK Investigational Site

    London, Ontario, N6A 4V2

  • GSK Investigational Site

    Montreal, Quebec, H1T 1C8

  • GSK Investigational Site

    Toronto, Ontario, M4N 3M5

  • GSK Investigational Site

    Toronto, Ontario, M5B 1W8

Other trials in Canada

Hong Kong5 sites

  • GSK Investigational Site

    Causeway Bay

  • GSK Investigational Site

    Kowloon

  • GSK Investigational Site

    Kwun Tong

  • GSK Investigational Site

    Pokfulam

  • GSK Investigational Site

    Shatin

Other trials in Hong Kong

Poland5 sites

  • GSK Investigational Site

    Bialystok, 15-276

  • GSK Investigational Site

    Kalisz, 62-800

  • GSK Investigational Site

    Katowice, 40-635

  • GSK Investigational Site

    Poznan, 60-355

  • GSK Investigational Site

    Warsaw, 04-628

Other trials in Poland

Brazil4 sites

  • GSK Investigational Site

    Ribeirão Preto, São Paulo, 14048-900

  • GSK Investigational Site

    São Paulo, São Paulo, 04012-909

  • GSK Investigational Site

    São Paulo, São Paulo, 05403-000

  • GSK Investigational Site

    São Paulo, São Paulo, 05651-901

Other trials in Brazil

France4 sites

  • GSK Investigational Site

    Corbeil-Essonnes, 91106

  • GSK Investigational Site

    Le Plessis-Robinson, 92350

  • GSK Investigational Site

    Marseille, 13005

  • GSK Investigational Site

    Rennes, 35033

Other trials in France

Greece4 sites

  • GSK Investigational Site

    Athens, 115 26

  • GSK Investigational Site

    Athens, 115 27

  • GSK Investigational Site

    Athens, 155 62

  • GSK Investigational Site

    Athens, 176 74

Other trials in Greece

South Korea4 sites

  • GSK Investigational Site

    Seoul, 110-744

  • GSK Investigational Site

    Seoul, 120-752

  • GSK Investigational Site

    Seoul, 138-736

  • GSK Investigational Site

    Suwon, 443-721

Other trials in South Korea

Russia3 sites

  • GSK Investigational Site

    Moscow, 105 229

  • GSK Investigational Site

    Moscow, 121552

  • GSK Investigational Site

    Moscow, 123182

Other trials in Russia

India2 sites

  • GSK Investigational Site

    Mumbai, 400005

  • GSK Investigational Site

    New Delhi, 110017

Other trials in India

Italy2 sites

  • GSK Investigational Site

    Rozzano (Mi), Lombardy, 20089

  • GSK Investigational Site

    Udine, Friuli Venezia Giulia, 33100

Other trials in Italy

Mexico2 sites

  • GSK Investigational Site

    Guadalajara, Jalisco, 44340

  • GSK Investigational Site

    Monterrey, Nuevo León, 64060

Other trials in Mexico

Sweden2 sites

  • GSK Investigational Site

    Gothenburg, SE-413 45

  • GSK Investigational Site

    Stockholm, SE-171 76

Other trials in Sweden

Thailand2 sites

  • GSK Investigational Site

    Bangkok, 10330

  • GSK Investigational Site

    Chiang Mai, 50200

Other trials in Thailand

Czechia1 site

  • GSK Investigational Site

    Hradec Králové, 500 05

Other trials in Czechia

Latvia1 site

  • GSK Investigational Site

    Riga, LV1002

Other trials in Latvia

About this study

Official title: A Phase III, 18 Month, Multicenter, Randomized, Double-Blind, Active-Controlled Clinical Trial to Compare Rosiglitazone Versus Glipizide on the Progression of Atherosclerosis in Subjects With Type 2 Diabetes Mellitus and Cardiovascular Disease (APPROACH)

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
Being tested
Glipizide, rosiglitazone maleate
Keywords
atheroma, IVUS, Intravascular ultrasound, atherosclerosis
Medical subject headings
Atherosclerosis, Plaque, Atherosclerotic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GlipizideDrug

    oral anti-diabetic medication

  • rosiglitazone maleateDrug

    oral antidiabetic medication

Study groups in NCT00116831
Study groupRoleWhat they receive
GlipizideActive comparatororal anti-diabetic medication
Receives: Drug: Glipizide
rosiglitazone maleateExperimentaloral anti-diabetic medication
Receives: Drug: rosiglitazone maleate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Percent Atheroma Volume (PAV) to Month 18

    The primary efficacy endpoint was change in PAV (defined as total atheroma volume divided by total vessel volume x 100) within a 40 mm segment in non-intervened coronary arteries from Baseline to Month 18, based upon Intravascular Ultrasound (IVUS) assessment.

    Measured: Baseline to Month 18

  2. Model Adjusted Change From Baseline in Percent Atheroma Volume (PAV) to Month 18

    Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior Oral Anti-Hyperglycemic Diabetic Medications(s) (OAD).

    Measured: Baseline to Month 18

Secondary outcomes (34)

  1. Change From Baseline in Atheroma, Vessel, and Lumen Volume to Month 18

    IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18

    Measured: Baseline to Month 18

  2. Model Adjusted Change From Baseline in Atheroma Volume to Month 18

    IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.

    Measured: Baseline to Month 18

  3. Model Adjusted Change From Baseline in Lumen Volume to Month 18

    IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.

    Measured: Baseline to Month 18

  4. Model Adjusted Change From Baseline in Vessel Volume to Month 18

    IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.

    Measured: Baseline to Month 18

  5. Change From Baseline in Atheroma, Vessel, and Lumen Area to Month 18

    IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18

    Measured: Baseline to Month 18

  6. Model Adjusted Change From Baseline in Atheroma Area to Month 18

    IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.

    Measured: Baseline to Month 18

  7. Model Adjusted Change From Baseline in Lumen Area to Month 18

    IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.

    Measured: Baseline to Month 18

  8. Model Adjusted Change From Baseline in Vessel Area to Month 18

    IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.

    Measured: Baseline to Month 18

  9. Change From Baseline in Normalized Atheroma Volume

    IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Normalized atheroma volume is defined as mean atheroma area x median segment length in cohort.

    Measured: Baseline to Month 18

  10. Model Adjusted Change From Baseline in Normalized Atheroma Volume

    IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Normalized atheroma volume is defined as mean atheroma area x median segment length in cohort. Model Adjusted Change = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.

    Measured: Baseline to Month 18

  11. Change in Atheroma Volume Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline

    IVUS-derived endpoints measured within the same 10 mm segment of non-intervened coronary arteries with the greatest degree of atheroma volume at Baseline, from Baseline to Month 18, including the nominal change in atheroma volume and atheroma area

    Measured: Baseline to Month 18

  12. Model Adjusted Change in Atheroma Volume Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline

    IVUS-derived endpoints measured within the same 10 mm segment of non-intervened coronary arteries with the greatest degree of atheroma volume at Baseline, from Baseline to Month 18, including the nominal change in atheroma volume and atheroma area. Model Adjusted Change = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.

    Measured: Baseline to Month 18

  13. Change in Atheroma Area Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline

    IVUS-derived endpoints measured within the same 10 mm segment of non-intervened coronary arteries with the greatest degree of atheroma volume at Baseline, from Baseline to Month 18, including the nominal change in atheroma volume and atheroma area

    Measured: Baseline to Month 18

  14. Model Adjusted Change in Atheroma Area Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline

    IVUS-derived endpoints measured within the same 10 mm segment of non-intervened coronary arteries with the greatest degree of atheroma volume at Baseline, from Baseline to Month 18, including the nominal change in atheroma volume and atheroma area. Model Adjusted Change = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.

    Measured: Baseline to Month 18

  15. Model Adjusted Change in Glycated Hemoglobin (HbA1c) From Baseline to Month 18

    From repeated measures analysis model: Change = Baseline + visit + sex + region + treatment + prior Oral Anti-Hyperglycemic Diabetic Medications(s) (OAD) + cardiac procedure + treatment x visit.

    Measured: Baseline to Month 18

  16. Model Adjusted Change in Fasting Plasma Glucose (FPG) From Baseline to Month 18

    From repeated measures analysis model: Change = Baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.

    Measured: Baseline to Month 18

  17. Repeated Measures Analysis of Percent Change in hsCRP From Baseline to Month 18

    Changes in cardiovascular biomarkers from Baseline to Month 18, such as high sensitivity C-reactive protein (hsCRP) . Repeated measures analysis model: Log(value) - log(baseline) = log(baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.

    Measured: Baseline to Month 18

  18. Repeated Measures Analysis of Percent Change in MMP 9 From Baseline to Month 18

    Changes in cardiovascular biomarkers from Baseline to Month 18, such as matrix metalloproteinase-9 (MMP-9). Repeated measures analysis model: Log(value) - log(baseline) = log(baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.

    Measured: Baseline to Month 18

  19. Percent Change in Brain Natriuretic Peptide (BNP) From Baseline to Month 18

    It was measured as ratio to baseline as percentage change based on log-transformed data : 100 x (exp(Mean change on log scale) - 1)It was measured as ratio to baseline as percentage change based on log-transformed data : 100 x (exp(Mean change on log scale) - 1). Ratio to baseline as %change mean (%) was used as the estimation parameter for both groups.

    Measured: Baseline to Month 18

  20. Model Adjusted Percent Change in Brain Natriuretic Peptide (BNP) From Baseline to Month 18

    It was measured as ratio to baseline as percentage change based on log-transformed data : 100 x (exp(Mean change on log scale) - 1). Model Adjusted change based on ANCOVA: Log(value) - log(Baseline) = log(Baseline) + sex + region + treatment + prior OAD + cardiac procedure.

    Measured: Baseline to Month 18

  21. Percent Change From Baseline to Month 18 in Total Cholesterol (TC)

    Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.

    Measured: Baseline to Month 18

  22. Percent Change From Baseline to Month 18 in High Density Lipoprotein Cholesterol (HDL-c)

    Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.

    Measured: Baseline to Month 18

  23. Percent Change From Baseline to Month 18 in HDL-2

    Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.

    Measured: Baseline to Month 18

  24. Percent Change From Baseline to Month 18 in HDL-3

    Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.

    Measured: Baseline to Month 18

  25. Percent Change From Baseline to Month 18 in Low Density Lipoprotein Cholesterol (LDL-c)

    Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.

    Measured: Baseline to Month 18

  26. Percent Change From Baseline to Month 18 in Triglycerides (TG)

    Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.

    Measured: Baseline to Month 18

  27. Percent Change From Baseline to Month 18 in Free Fatty Acids (FFA)

    Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.

    Measured: Baseline to Month 18

  28. Percent Change From Baseline to Month 18 in Apoprotein B (apoB)

    Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.

    Measured: Baseline to Month 18

  29. Change From Baseline to Month 18 in LDL-c Peak Particle Density Measured by LDL Relative Flotation

    From repeated measures analysis model: Change = baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.

    Measured: Baseline to Month 18

  30. Change From Baseline to Month 18 in Total Cholesterol/HDL-c Ratio

    From repeated measures analysis model: Change = baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.

    Measured: Baseline to Month 18

  31. Change From Baseline to Month 18 in LDL-c/HDL-c Ratio

    From repeated measures analysis model: Change = baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.

    Measured: Baseline to Month 18

  32. Number of Participants With the Indicated Treatment Emergent Major Cardiovascular Events (MACE) for All-cause Death, Non-fatal MI, Non-fatal Stroke, Coronary Revascularization, or Hospitalization for Recurrent Myocardial Ischemia (MACE Composite 1)

    This was 1 of 2 MACE composite endpoints and was a secondary efficacy endpoint.

    Measured: Baseline to Month 21

  33. Number of Participants With the Indicated Treatment Emergent Major Cardiovascular Events (MACE) for Cardiovascular Death, Nonfatal MI, or Nonfatal Stroke (MACE Composite 2)

    This was 1 of 2 MACE composite endpoints and was a secondary efficacy endpoint.

    Measured: Baseline to Month 21

  34. Number of Other Cardiovascular Events

    This was one of the secondary endpoints of the study.

    Measured: Baseline to Month 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2005 (estimated)
  2. Study startJan 2005
  3. Primary completionAug 2008
  4. Study completionAug 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
672 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00116831
Sponsor's protocol ID
AVD100521
Status last verified
Mar 2017
First submitted
30 Jun 2005
Last updated
23 Mar 2017
Data monitoring committee
Yes
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • 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.

    PubMed 21359834

  • 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).

  • 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)

  • 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.

    PubMed 19033001

  • 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.

    PubMed 20194881

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Glipizide and rosiglitazone maleate in people with Atherosclerosis, run by GlaxoSmithKline at 156 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 156 sites in United States, Germany, Argentina, Spain, Netherlands and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Percent Atheroma Volume (PAV) to Month 18 (time frame: Baseline to Month 18). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00116831, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2017.

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