Clinical trial NCT00116831: Rosiglitazone Versus a Sulfonylurea On Progression Of Atherosclerosis In Patients With Heart Disease And Type 2 Diabetes
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atherosclerosis
Keywords: atheroma
IVUS
Intravascular ultrasound
atherosclerosis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-07-01
Enrollment: 672
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change From Baseline in Percent Atheroma Volume (PAV) to Month 18
timeFrame: Baseline to Month 18
measure: Model Adjusted Change From Baseline in Percent Atheroma Volume (PAV) to Month 18
timeFrame: Baseline to Month 18
Secondary outcomes:
measure: Change From Baseline in Atheroma, Vessel, and Lumen Volume to Month 18
timeFrame: Baseline to Month 18
measure: Model Adjusted Change From Baseline in Atheroma Volume to Month 18
timeFrame: Baseline to Month 18
measure: Model Adjusted Change From Baseline in Lumen Volume to Month 18
timeFrame: Baseline to Month 18
measure: Model Adjusted Change From Baseline in Vessel Volume to Month 18
timeFrame: Baseline to Month 18
measure: Change From Baseline in Atheroma, Vessel, and Lumen Area to Month 18
timeFrame: Baseline to Month 18
measure: Model Adjusted Change From Baseline in Atheroma Area to Month 18
timeFrame: Baseline to Month 18
measure: Model Adjusted Change From Baseline in Lumen Area to Month 18
timeFrame: Baseline to Month 18
measure: Model Adjusted Change From Baseline in Vessel Area to Month 18
timeFrame: Baseline to Month 18
measure: Change From Baseline in Normalized Atheroma Volume
timeFrame: Baseline to Month 18
measure: Model Adjusted Change From Baseline in Normalized Atheroma Volume
timeFrame: Baseline to Month 18
measure: Change in Atheroma Volume Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline
timeFrame: Baseline to Month 18
measure: Model Adjusted Change in Atheroma Volume Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline
timeFrame: Baseline to Month 18
measure: Change in Atheroma Area Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline
timeFrame: Baseline to Month 18
measure: Model Adjusted Change in Atheroma Area Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline
timeFrame: Baseline to Month 18
measure: Model Adjusted Change in Glycated Hemoglobin (HbA1c) From Baseline to Month 18
timeFrame: Baseline to Month 18
measure: Model Adjusted Change in Fasting Plasma Glucose (FPG) From Baseline to Month 18
timeFrame: Baseline to Month 18
measure: Repeated Measures Analysis of Percent Change in hsCRP From Baseline to Month 18
timeFrame: Baseline to Month 18
measure: Repeated Measures Analysis of Percent Change in MMP 9 From Baseline to Month 18
timeFrame: Baseline to Month 18
measure: Percent Change in Brain Natriuretic Peptide (BNP) From Baseline to Month 18
timeFrame: Baseline to Month 18
measure: Model Adjusted Percent Change in Brain Natriuretic Peptide (BNP) From Baseline to Month 18
timeFrame: Baseline to Month 18
measure: Percent Change From Baseline to Month 18 in Total Cholesterol (TC)
timeFrame: Baseline to Month 18
measure: Percent Change From Baseline to Month 18 in High Density Lipoprotein Cholesterol (HDL-c)
timeFrame: Baseline to Month 18
measure: Percent Change From Baseline to Month 18 in HDL-2
timeFrame: Baseline to Month 18
measure: Percent Change From Baseline to Month 18 in HDL-3
timeFrame: Baseline to Month 18
measure: Percent Change From Baseline to Month 18 in Low Density Lipoprotein Cholesterol (LDL-c)
timeFrame: Baseline to Month 18
measure: Percent Change From Baseline to Month 18 in Triglycerides (TG)
timeFrame: Baseline to Month 18
measure: Percent Change From Baseline to Month 18 in Free Fatty Acids (FFA)
timeFrame: Baseline to Month 18
measure: Percent Change From Baseline to Month 18 in Apoprotein B (apoB)
timeFrame: Baseline to Month 18
measure: Change From Baseline to Month 18 in LDL-c Peak Particle Density Measured by LDL Relative Flotation
timeFrame: Baseline to Month 18
measure: Change From Baseline to Month 18 in Total Cholesterol/HDL-c Ratio
timeFrame: Baseline to Month 18
measure: Change From Baseline to Month 18 in LDL-c/HDL-c Ratio
timeFrame: Baseline to Month 18
measure: 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)
timeFrame: Baseline to Month 21
measure: Number of Participants With the Indicated Treatment Emergent Major Cardiovascular Events (MACE) for Cardiovascular Death, Nonfatal MI, or Nonfatal Stroke (MACE Composite 2)
timeFrame: Baseline to Month 21
measure: Number of Other Cardiovascular Events
timeFrame: Baseline to Month 21
Other outcomes:
Locations:
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city: London
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state: Quebec
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city: Corbeil Essonnes Cedex
country: France
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city: Le Plessis Robinson
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city: Marseille
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state: Bayern
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city: Dortmund
country: Germany
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country: Germany
facility: GSK Investigational Site
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city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Essen
country: Germany
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state: Nordrhein-Westfalen
city: Essen
country: Germany
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state: Rheinland-Pfalz
city: Trier
country: Germany
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state: Rheinland-Pfalz
city: Trier
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country: Germany
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city: Saarlouis
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city: Athens
country: Greece
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country: Greece
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
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country: Hong Kong
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city: Kowloon
country: Hong Kong
facility: GSK Investigational Site
city: Kwun Tong
country: Hong Kong
facility: GSK Investigational Site
city: Pokfulam
country: Hong Kong
facility: GSK Investigational Site
city: Shatin
country: Hong Kong
facility: GSK Investigational Site
city: Mumbai
country: India
facility: GSK Investigational Site
city: New Delhi
country: India
facility: GSK Investigational Site
city: Udine
country: Italy
facility: GSK Investigational Site
state: Friuli-Venezia-Giulia
city: Rozzano (Mi)
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Suwon-Si
country: Korea, Republic of
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Monterrey
country: Mexico
facility: GSK Investigational Site
state: Nuevo León
city: Breda
country: Netherlands
facility: GSK Investigational Site
city: Eindhoven
country: Netherlands
facility: GSK Investigational Site
city: Enschede
country: Netherlands
facility: GSK Investigational Site
city: Nieuwegein
country: Netherlands
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Zwolle
country: Netherlands
facility: GSK Investigational Site
city: Bialystok
country: Poland
facility: GSK Investigational Site
city: Kalisz
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Alicante
country: Spain
facility: GSK Investigational Site
city: Badalona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Malaga
country: Spain
facility: GSK Investigational Site
city: Marid
country: Spain
facility: GSK Investigational Site
city: Murcia
country: Spain
facility: GSK Investigational Site
city: Oviedo
country: Spain
facility: GSK Investigational Site
city: San Juan/Alicante
country: Spain
facility: GSK Investigational Site
city: Göteborg
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Chiang Mai
country: Thailand
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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).
citation: 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)
citation: 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.
citation: 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.