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

March 21, 2017 updated by: GlaxoSmithKline

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.

Study Overview

Status

Completed

Conditions

Atherosclerosis

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

672

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, 1428
    - GSK Investigational Site
  - Ciudad Autónoma de Buenos Aires, Argentina, 1221
    - GSK Investigational Site
  - Ciudad Autónoma de Buenos Aires, Argentina, 1405
    - GSK Investigational Site
  - Ciudad Autónoma de Buenos Aires, Argentina, 1416
    - GSK Investigational Site
  - Ciudad Autónoma de Buenos Aires, Argentina, C1416DRW
    - GSK Investigational Site
  - Cordoba, Argentina, 5000
    - GSK Investigational Site
  - Moron-Provincia de Buenos Aires, Argentina, 1709
    - GSK Investigational Site
- Buenos Aires
  - Capital Federal, Buenos Aires, Argentina, 1181
    - GSK Investigational Site
  - Capital Federal, Buenos Aires, Argentina, C1437JCP
    - GSK Investigational Site
  - Capital Federal, Buenos Aires, Argentina, C1155ADP
    - GSK Investigational Site
  - Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, B1704ETD
    - GSK Investigational Site
  - Munro, Buenos Aires, Argentina, 1605
    - GSK Investigational Site
  - San Justo, Buenos Aires, Argentina, B7118XAB
    - GSK Investigational Site
  - San Martín, Buenos Aires, Argentina, 1650
    - GSK Investigational Site
- Córdova
  - Córdoba, Córdova, Argentina, 5000
    - GSK Investigational Site
Brazil
- - São Paulo, Brazil, 05403-000
    - GSK Investigational Site
  - São Paulo, Brazil, 05651-901
    - GSK Investigational Site
  - São Paulo, Brazil, 04012-909
    - GSK Investigational Site
- São Paulo
  - Ribeirão Preto, São Paulo, Brazil, 14048-900
    - GSK Investigational Site
Canada
- Ontario
  - Hamilton, Ontario, Canada, L8L 2X2
    - GSK Investigational Site
  - London, Ontario, Canada, N6A 4V2
    - GSK Investigational Site
  - Toronto, Ontario, Canada, M4N 3M5
    - GSK Investigational Site
  - Toronto, Ontario, Canada, M5B 1W8
    - GSK Investigational Site
- Quebec
  - Montreal, Quebec, Canada, H1T 1C8
    - GSK Investigational Site
Czech Republic
- - Hradec Kralove, Czech Republic, 500 05
    - GSK Investigational Site
France
- - Corbeil Essonnes Cedex, France, 91106
    - GSK Investigational Site
  - Le Plessis Robinson, France, 92350
    - GSK Investigational Site
  - Marseille, France, 13005
    - GSK Investigational Site
  - Rennes Cedex, France, 35033
    - GSK Investigational Site
Germany
- Baden-Wuerttemberg
  - Heidelberg, Baden-Wuerttemberg, Germany, 69120
    - GSK Investigational Site
  - Heidelberg, Baden-Wuerttemberg, Germany, 69126
    - GSK Investigational Site
  - Mannheim, Baden-Wuerttemberg, Germany, 68161
    - GSK Investigational Site
- Bayern
  - Coburg, Bayern, Germany, 96450
    - GSK Investigational Site
  - Kronach, Bayern, Germany, 96317
    - GSK Investigational Site
  - Kulmbach, Bayern, Germany, 95326
    - GSK Investigational Site
  - Lichtenfels, Bayern, Germany, 96215
    - GSK Investigational Site
- Hessen
  - Hirschhorn, Hessen, Germany, 69434
    - GSK Investigational Site
  - Lampertheim, Hessen, Germany, 68623
    - GSK Investigational Site
- Nordrhein-Westfalen
  - Bochum, Nordrhein-Westfalen, Germany, 44789
    - GSK Investigational Site
  - Dinslaken, Nordrhein-Westfalen, Germany, 46537
    - GSK Investigational Site
  - Dormagen, Nordrhein-Westfalen, Germany, 41539
    - GSK Investigational Site
  - Dortmund, Nordrhein-Westfalen, Germany, 44137
    - GSK Investigational Site
  - Dortmund, Nordrhein-Westfalen, Germany, 44328
    - GSK Investigational Site
  - Dortmund, Nordrhein-Westfalen, Germany, 44339
    - GSK Investigational Site
  - Duesseldorf, Nordrhein-Westfalen, Germany, 40454
    - GSK Investigational Site
  - Duisburg, Nordrhein-Westfalen, Germany, 47119
    - GSK Investigational Site
  - Essen, Nordrhein-Westfalen, Germany, 45355
    - GSK Investigational Site
  - Essen, Nordrhein-Westfalen, Germany, 45359
    - GSK Investigational Site
  - Essen, Nordrhein-Westfalen, Germany, 45122
    - GSK Investigational Site
  - Essen, Nordrhein-Westfalen, Germany, 45136
    - GSK Investigational Site
  - Essen, Nordrhein-Westfalen, Germany, 45329
    - GSK Investigational Site
  - Essen, Nordrhein-Westfalen, Germany, 45309
    - GSK Investigational Site
  - Gelsenkirchen, Nordrhein-Westfalen, Germany, 45881
    - GSK Investigational Site
  - Herne, Nordrhein-Westfalen, Germany, 44623
    - GSK Investigational Site
  - Herne, Nordrhein-Westfalen, Germany, 44653
    - GSK Investigational Site
  - Leverkusen, Nordrhein-Westfalen, Germany, 51377
    - GSK Investigational Site
  - Luenen, Nordrhein-Westfalen, Germany, 44534
    - GSK Investigational Site
  - Marl, Nordrhein-Westfalen, Germany, 45772
    - GSK Investigational Site
  - Oberhausen, Nordrhein-Westfalen, Germany, 46049
    - GSK Investigational Site
- Rheinland-Pfalz
  - Ludwigshafen, Rheinland-Pfalz, Germany, 67063
    - GSK Investigational Site
  - Rhaunen, Rheinland-Pfalz, Germany, 55624
    - GSK Investigational Site
  - Speyer, Rheinland-Pfalz, Germany, 67346
    - GSK Investigational Site
  - Trier, Rheinland-Pfalz, Germany, 54292
    - GSK Investigational Site
  - Trier, Rheinland-Pfalz, Germany, 54296
    - GSK Investigational Site
- Saarland
  - Friedrichsthal, Saarland, Germany, 66299
    - GSK Investigational Site
  - Saarlouis, Saarland, Germany, 66740
    - GSK Investigational Site
  - Sr. Ingbert, Saarland, Germany, 66386
    - GSK Investigational Site
Greece
- - Athens, Greece, 115 27
    - GSK Investigational Site
  - Athens, Greece, 115 26
    - GSK Investigational Site
  - Athens, Greece, 176 74
    - GSK Investigational Site
  - Athens, Greece, 155 62
    - GSK Investigational Site
Hong Kong
- - 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
India
- - Mumbai, India, 400005
    - GSK Investigational Site
  - New Delhi, India, 110017
    - GSK Investigational Site
Italy
- Friuli-Venezia-Giulia
  - Udine, Friuli-Venezia-Giulia, Italy, 33100
    - GSK Investigational Site
- Lombardia
  - Rozzano (Mi), Lombardia, Italy, 20089
    - GSK Investigational Site
Korea, Republic of
- - Seoul, Korea, Republic of, 120-752
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 138-736
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 110-744
    - GSK Investigational Site
  - Suwon-Si, Korea, Republic of, 443-721
    - GSK Investigational Site
Latvia
- - Riga, Latvia, LV1002
    - GSK Investigational Site
Mexico
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44340
    - GSK Investigational Site
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64060
    - GSK Investigational Site
Netherlands
- - Breda, Netherlands, 4818 CK
    - GSK Investigational Site
  - Eindhoven, Netherlands, 5623 EJ
    - GSK Investigational Site
  - Enschede, Netherlands, 7511JX
    - GSK Investigational Site
  - Nieuwegein, Netherlands, 3435 CM
    - GSK Investigational Site
  - Rotterdam, Netherlands, 3015 GD
    - GSK Investigational Site
  - Rotterdam, Netherlands, 3075 EA
    - GSK Investigational Site
  - Zwolle, Netherlands, 8011 JW
    - GSK Investigational Site
Poland
- - Bialystok, Poland, 15-276
    - GSK Investigational Site
  - Kalisz, Poland, 62-800
    - GSK Investigational Site
  - Katowice, Poland, 40-635
    - GSK Investigational Site
  - Poznan, Poland, 60-355
    - GSK Investigational Site
  - Warszawa, Poland, 04-628
    - GSK Investigational Site
Russian Federation
- - Moscow, Russian Federation, 123182
    - GSK Investigational Site
  - Moscow, Russian Federation, 105 229
    - GSK Investigational Site
  - Moscow, Russian Federation, 121552
    - GSK Investigational Site
Spain
- - Alicante, Spain, 03010
    - GSK Investigational Site
  - Badalona, Spain, 08916
    - GSK Investigational Site
  - Barcelona, Spain, 08036
    - GSK Investigational Site
  - Barcelona, Spain, 08035
    - GSK Investigational Site
  - Barcelona, Spain, 08097
    - GSK Investigational Site
  - Madrid, Spain, 28035
    - GSK Investigational Site
  - Malaga, Spain, 29010
    - GSK Investigational Site
  - Marid, Spain, 28040
    - GSK Investigational Site
  - Murcia, Spain, 30120
    - GSK Investigational Site
  - Oviedo, Spain, 33006
    - GSK Investigational Site
  - San Juan/Alicante, Spain, 03550
    - GSK Investigational Site
Sweden
- - Göteborg, Sweden, SE-413 45
    - GSK Investigational Site
  - Stockholm, Sweden, SE-171 76
    - GSK Investigational Site
Thailand
- - Bangkok, Thailand, 10330
    - GSK Investigational Site
  - Chiang Mai, Thailand, 50200
    - GSK Investigational Site
United States
- Alabama
  - Birmingham, Alabama, United States, 35235
    - GSK Investigational Site
- Arizona
  - Scottsdale, Arizona, United States, 85251
    - GSK Investigational Site
  - Tucson, Arizona, United States, 85745
    - GSK Investigational Site
- California
  - Burbank, California, United States, 91505
    - GSK Investigational Site
  - Huntington Beach, California, United States, 92648
    - GSK Investigational Site
  - Los Angeles, California, United States, 90017
    - GSK Investigational Site
  - Mission Viejo, California, United States, 92691
    - GSK Investigational Site
  - Sacramento, California, United States, 95825
    - GSK Investigational Site
  - Sacramento, California, United States, 95817
    - GSK Investigational Site
  - Torrance, California, United States, 90509
    - GSK Investigational Site
  - Torrance, California, United States, 90503
    - GSK Investigational Site
- Colorado
  - Denver, Colorado, United States, 80220
    - GSK Investigational Site
  - Englewood, Colorado, United States, 80113
    - GSK Investigational Site
- District of Columbia
  - Washington, District of Columbia, United States, 20010
    - GSK Investigational Site
- Florida
  - Melbourne, Florida, United States, 32901
    - GSK Investigational Site
  - Tampa, Florida, United States, 33609
    - GSK Investigational Site
- Georgia
  - Atlanta, Georgia, United States, 30309
    - GSK Investigational Site
- Illinois
  - Peoria, Illinois, United States, 61615
    - GSK Investigational Site
  - Springfield, Illinois, United States, 62702
    - GSK Investigational Site
- Indiana
  - Indianapolis, Indiana, United States, 46260
    - GSK Investigational Site
- Maryland
  - Baltimore, Maryland, United States, 21287
    - GSK Investigational Site
  - Columbia, Maryland, United States, 21044
    - GSK Investigational Site
- Massachusetts
  - Springfield, Massachusetts, United States, 01199
    - GSK Investigational Site
- Missouri
  - Springfield, Missouri, United States, 65807
    - GSK Investigational Site
- New Jersey
  - New Brunswick, New Jersey, United States, 08903
    - GSK Investigational Site
- New York
  - Albany, New York, United States, 12208
    - GSK Investigational Site
  - New York, New York, United States, 10032
    - GSK Investigational Site
- North Carolina
  - Winston-Salem, North Carolina, United States, 27157
    - GSK Investigational Site
  - Winston-Salem, North Carolina, United States, 27103
    - GSK Investigational Site
- Ohio
  - Canton, Ohio, United States, 44708
    - GSK Investigational Site
- Pennsylvania
  - Beaver, Pennsylvania, United States, 15009
    - GSK Investigational Site
  - Camp Hill, Pennsylvania, United States, 17011
    - GSK Investigational Site
  - Philadelphia, Pennsylvania, United States, 19141
    - GSK Investigational Site
- Tennessee
  - Jackson, Tennessee, United States, 38301
    - GSK Investigational Site
- Texas
  - Corpus Christi, Texas, United States, 78404
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78229
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78207
    - GSK Investigational Site
- Washington
  - Bellevue, Washington, United States, 98004
    - GSK Investigational Site
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53215
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Glipizide oral anti-diabetic medication	Drug: Glipizide oral anti-diabetic medication
Experimental: rosiglitazone maleate oral anti-diabetic medication	Drug: rosiglitazone maleate oral antidiabetic medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Percent Atheroma Volume (PAV) to Month 18 Time Frame: Baseline 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.	Baseline to Month 18
Model Adjusted Change From Baseline in Percent Atheroma Volume (PAV) to Month 18 Time Frame: Baseline to Month 18	Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior Oral Anti-Hyperglycemic Diabetic Medications(s) (OAD).	Baseline to Month 18

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Atheroma, Vessel, and Lumen Volume to Month 18 Time Frame: Baseline to Month 18	IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18	Baseline to Month 18
Model Adjusted Change From Baseline in Atheroma Volume to Month 18 Time Frame: Baseline 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.	Baseline to Month 18
Model Adjusted Change From Baseline in Lumen Volume to Month 18 Time Frame: Baseline 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.	Baseline to Month 18
Model Adjusted Change From Baseline in Vessel Volume to Month 18 Time Frame: Baseline 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.	Baseline to Month 18
Change From Baseline in Atheroma, Vessel, and Lumen Area to Month 18 Time Frame: Baseline to Month 18	IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18	Baseline to Month 18
Model Adjusted Change From Baseline in Atheroma Area to Month 18 Time Frame: Baseline 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.	Baseline to Month 18
Model Adjusted Change From Baseline in Lumen Area to Month 18 Time Frame: Baseline 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.	Baseline to Month 18
Model Adjusted Change From Baseline in Vessel Area to Month 18 Time Frame: Baseline 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.	Baseline to Month 18
Change From Baseline in Normalized Atheroma Volume Time Frame: Baseline to Month 18	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.	Baseline to Month 18
Model Adjusted Change From Baseline in Normalized Atheroma Volume Time Frame: Baseline to Month 18	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.	Baseline to Month 18
Change in Atheroma Volume Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline Time Frame: Baseline to Month 18	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	Baseline to Month 18
Model Adjusted Change in Atheroma Volume Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline Time Frame: Baseline to Month 18	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.	Baseline to Month 18
Change in Atheroma Area Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline Time Frame: Baseline to Month 18	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	Baseline to Month 18
Model Adjusted Change in Atheroma Area Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline Time Frame: Baseline to Month 18	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.	Baseline to Month 18
Model Adjusted Change in Glycated Hemoglobin (HbA1c) From Baseline to Month 18 Time Frame: 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.	Baseline to Month 18
Model Adjusted Change in Fasting Plasma Glucose (FPG) From Baseline to Month 18 Time Frame: Baseline to Month 18	From repeated measures analysis model: Change = Baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.	Baseline to Month 18
Repeated Measures Analysis of Percent Change in hsCRP From Baseline to Month 18 Time Frame: 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.	Baseline to Month 18
Repeated Measures Analysis of Percent Change in MMP 9 From Baseline to Month 18 Time Frame: 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.	Baseline to Month 18
Percent Change in Brain Natriuretic Peptide (BNP) From Baseline to Month 18 Time Frame: 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.	Baseline to Month 18
Model Adjusted Percent Change in Brain Natriuretic Peptide (BNP) From Baseline to Month 18 Time Frame: 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.	Baseline to Month 18
Percent Change From Baseline to Month 18 in Total Cholesterol (TC) Time Frame: Baseline to Month 18	Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.	Baseline to Month 18
Percent Change From Baseline to Month 18 in High Density Lipoprotein Cholesterol (HDL-c) Time Frame: Baseline to Month 18	Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.	Baseline to Month 18
Percent Change From Baseline to Month 18 in HDL-2 Time Frame: Baseline to Month 18	Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.	Baseline to Month 18
Percent Change From Baseline to Month 18 in HDL-3 Time Frame: Baseline to Month 18	Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.	Baseline to Month 18
Percent Change From Baseline to Month 18 in Low Density Lipoprotein Cholesterol (LDL-c) Time Frame: Baseline to Month 18	Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.	Baseline to Month 18
Percent Change From Baseline to Month 18 in Triglycerides (TG) Time Frame: Baseline to Month 18	Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.	Baseline to Month 18
Percent Change From Baseline to Month 18 in Free Fatty Acids (FFA) Time Frame: Baseline to Month 18	Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.	Baseline to Month 18
Percent Change From Baseline to Month 18 in Apoprotein B (apoB) Time Frame: Baseline to Month 18	Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.	Baseline to Month 18
Change From Baseline to Month 18 in LDL-c Peak Particle Density Measured by LDL Relative Flotation Time Frame: Baseline to Month 18	From repeated measures analysis model: Change = baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.	Baseline to Month 18
Change From Baseline to Month 18 in Total Cholesterol/HDL-c Ratio Time Frame: Baseline to Month 18	From repeated measures analysis model: Change = baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.	Baseline to Month 18
Change From Baseline to Month 18 in LDL-c/HDL-c Ratio Time Frame: Baseline to Month 18	From repeated measures analysis model: Change = baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.	Baseline to Month 18
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) Time Frame: Baseline to Month 21	This was 1 of 2 MACE composite endpoints and was a secondary efficacy endpoint.	Baseline to Month 21
Number of Participants With the Indicated Treatment Emergent Major Cardiovascular Events (MACE) for Cardiovascular Death, Nonfatal MI, or Nonfatal Stroke (MACE Composite 2) Time Frame: Baseline to Month 21	This was 1 of 2 MACE composite endpoints and was a secondary efficacy endpoint.	Baseline to Month 21
Number of Other Cardiovascular Events Time Frame: Baseline to Month 21	This was one of the secondary endpoints of the study.	Baseline to Month 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.
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.
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.

Helpful Links

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

June 30, 2005

First Submitted That Met QC Criteria

June 30, 2005

First Posted (Estimate)

July 1, 2005

Study Record Updates

Last Update Posted (Actual)

March 23, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

AVD100521

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

Dataset Specification
Information identifier: AVD100521

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set
Information identifier: AVD100521

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form
Information identifier: AVD100521

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol
Information identifier: AVD100521

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report
Information identifier: AVD100521

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form
Information identifier: AVD100521

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan
Information identifier: AVD100521

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Study Data/Documents

Clinical Trials on Atherosclerosis

Clinical Trials on Glipizide

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