Clinical Trial Details
| Trial ID: | L1916 |
| Source ID: | NCT00116831 |
| Associated Drug: | Glipizide |
| Title: | Rosiglitazone Versus a Sulfonylurea On Progression Of Atherosclerosis In Patients With Heart Disease And Type 2 Diabetes |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00116831/results |
| Conditions: | Atherosclerosis |
| Interventions: | DRUG: Glipizide|DRUG: rosiglitazone maleate |
| Outcome Measures: | Primary: 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., Baseline to Month 18|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)., Baseline to Month 18 | Secondary: 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, Baseline to Month 18|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., Baseline to Month 18|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., Baseline to Month 18|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., Baseline to Month 18|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, Baseline to Month 18|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., Baseline to Month 18|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., Baseline to Month 18|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., Baseline to Month 18|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., Baseline to Month 18|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., 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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), 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), 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, 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, 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), 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), 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), 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), 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, 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, 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, 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), 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), This was 1 of 2 MACE composite endpoints and was a secondary efficacy endpoint., Baseline to Month 21|Number of Other Cardiovascular Events, This was one of the secondary endpoints of the study., Baseline to Month 21 |
| Sponsor/Collaborators: | Sponsor: GlaxoSmithKline |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 672 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2005-01 |
| Completion Date: | 2008-08 |
| Results First Posted: | 2010-03-31 |
| Last Update Posted: | 2017-03-23 |
| Locations: | GSK Investigational Site, Birmingham, Alabama, 35235, United States|GSK Investigational Site, Scottsdale, Arizona, 85251, United States|GSK Investigational Site, Tucson, Arizona, 85745, United States|GSK Investigational Site, Burbank, California, 91505, United States|GSK Investigational Site, Huntington Beach, California, 92648, United States|GSK Investigational Site, Los Angeles, California, 90017, United States|GSK Investigational Site, Mission Viejo, California, 92691, United States|GSK Investigational Site, Sacramento, California, 95817, United States|GSK Investigational Site, Sacramento, California, 95825, United States|GSK Investigational Site, Torrance, California, 90503, United States|GSK Investigational Site, Torrance, California, 90509, United States|GSK Investigational Site, Denver, Colorado, 80220, United States|GSK Investigational Site, Englewood, Colorado, 80113, United States|GSK Investigational Site, Washington, District of Columbia, 20010, United States|GSK Investigational Site, Melbourne, Florida, 32901, United States|GSK Investigational Site, Tampa, Florida, 33609, United States|GSK Investigational Site, Atlanta, Georgia, 30309, United States|GSK Investigational Site, Peoria, Illinois, 61615, United States|GSK Investigational Site, Springfield, Illinois, 62702, United States|GSK Investigational Site, Indianapolis, Indiana, 46260, United States|GSK Investigational Site, Baltimore, Maryland, 21287, United States|GSK Investigational Site, Columbia, Maryland, 21044, United States|GSK Investigational Site, Springfield, Massachusetts, 01199, United States|GSK Investigational Site, Springfield, Missouri, 65807, United States|GSK Investigational Site, New Brunswick, New Jersey, 08903, United States|GSK Investigational Site, Albany, New York, 12208, United States|GSK Investigational Site, New York, New York, 10032, United States|GSK Investigational Site, Winston-Salem, North Carolina, 27103, United States|GSK Investigational Site, Winston-Salem, North Carolina, 27157, United States|GSK Investigational Site, Canton, Ohio, 44708, United States|GSK Investigational Site, Beaver, Pennsylvania, 15009, United States|GSK Investigational Site, Camp Hill, Pennsylvania, 17011, United States|GSK Investigational Site, Philadelphia, Pennsylvania, 19141, United States|GSK Investigational Site, Jackson, Tennessee, 38301, United States|GSK Investigational Site, Corpus Christi, Texas, 78404, United States|GSK Investigational Site, San Antonio, Texas, 78207, United States|GSK Investigational Site, San Antonio, Texas, 78229, United States|GSK Investigational Site, Bellevue, Washington, 98004, United States|GSK Investigational Site, Milwaukee, Wisconsin, 53215, United States|GSK Investigational Site, Capital Federal, Buenos Aires, 1181, Argentina|GSK Investigational Site, Capital Federal, Buenos Aires, C1155ADP, Argentina|GSK Investigational Site, Capital Federal, Buenos Aires, C1437JCP, Argentina|GSK Investigational Site, Ciudad Autonoma de Buenos Aires, Buenos Aires, B1704ETD, Argentina|GSK Investigational Site, Munro, Buenos Aires, 1605, Argentina|GSK Investigational Site, San Justo, Buenos Aires, B7118XAB, Argentina|GSK Investigational Site, San Martín, Buenos Aires, 1650, Argentina|GSK Investigational Site, Córdoba, Córdova, 5000, Argentina|GSK Investigational Site, Buenos Aires, 1428, Argentina|GSK Investigational Site, Ciudad Autónoma de Buenos Aires, 1221, Argentina|GSK Investigational Site, Ciudad Autónoma de Buenos Aires, 1405, Argentina|GSK Investigational Site, Ciudad Autónoma de Buenos Aires, 1416, Argentina|GSK Investigational Site, Ciudad Autónoma de Buenos Aires, C1416DRW, Argentina|GSK Investigational Site, Cordoba, 5000, Argentina|GSK Investigational Site, Moron-Provincia de Buenos Aires, 1709, Argentina|GSK Investigational Site, Ribeirão Preto, São Paulo, 14048-900, Brazil|GSK Investigational Site, São Paulo, 04012-909, Brazil|GSK Investigational Site, São Paulo, 05403-000, Brazil|GSK Investigational Site, São Paulo, 05651-901, Brazil|GSK Investigational Site, Hamilton, Ontario, L8L 2X2, Canada|GSK Investigational Site, London, Ontario, N6A 4V2, Canada|GSK Investigational Site, Toronto, Ontario, M4N 3M5, Canada|GSK Investigational Site, Toronto, Ontario, M5B 1W8, Canada|GSK Investigational Site, Montreal, Quebec, H1T 1C8, Canada|GSK Investigational Site, Hradec Kralove, 500 05, Czech Republic|GSK Investigational Site, Corbeil Essonnes Cedex, 91106, France|GSK Investigational Site, Le Plessis Robinson, 92350, France|GSK Investigational Site, Marseille, 13005, France|GSK Investigational Site, Rennes Cedex, 35033, France|GSK Investigational Site, Heidelberg, Baden-Wuerttemberg, 69120, Germany|GSK Investigational Site, Heidelberg, Baden-Wuerttemberg, 69126, Germany|GSK Investigational Site, Mannheim, Baden-Wuerttemberg, 68161, Germany|GSK Investigational Site, Coburg, Bayern, 96450, Germany|GSK Investigational Site, Kronach, Bayern, 96317, Germany|GSK Investigational Site, Kulmbach, Bayern, 95326, Germany|GSK Investigational Site, Lichtenfels, Bayern, 96215, Germany|GSK Investigational Site, Hirschhorn, Hessen, 69434, Germany|GSK Investigational Site, Lampertheim, Hessen, 68623, Germany|GSK Investigational Site, Bochum, Nordrhein-Westfalen, 44789, Germany|GSK Investigational Site, Dinslaken, Nordrhein-Westfalen, 46537, Germany|GSK Investigational Site, Dormagen, Nordrhein-Westfalen, 41539, Germany|GSK Investigational Site, Dortmund, Nordrhein-Westfalen, 44137, Germany|GSK Investigational Site, Dortmund, Nordrhein-Westfalen, 44328, Germany|GSK Investigational Site, Dortmund, Nordrhein-Westfalen, 44339, Germany|GSK Investigational Site, Duesseldorf, Nordrhein-Westfalen, 40454, Germany|GSK Investigational Site, Duisburg, Nordrhein-Westfalen, 47119, Germany|GSK Investigational Site, Essen, Nordrhein-Westfalen, 45122, Germany|GSK Investigational Site, Essen, Nordrhein-Westfalen, 45136, Germany|GSK Investigational Site, Essen, Nordrhein-Westfalen, 45309, Germany|GSK Investigational Site, Essen, Nordrhein-Westfalen, 45329, Germany|GSK Investigational Site, Essen, Nordrhein-Westfalen, 45355, Germany|GSK Investigational Site, Essen, Nordrhein-Westfalen, 45359, Germany|GSK Investigational Site, Gelsenkirchen, Nordrhein-Westfalen, 45881, Germany|GSK Investigational Site, Herne, Nordrhein-Westfalen, 44623, Germany|GSK Investigational Site, Herne, Nordrhein-Westfalen, 44653, Germany|GSK Investigational Site, Leverkusen, Nordrhein-Westfalen, 51377, Germany|GSK Investigational Site, Luenen, Nordrhein-Westfalen, 44534, Germany|GSK Investigational Site, Marl, Nordrhein-Westfalen, 45772, Germany|GSK Investigational Site, Oberhausen, Nordrhein-Westfalen, 46049, Germany|GSK Investigational Site, Ludwigshafen, Rheinland-Pfalz, 67063, Germany|GSK Investigational Site, Rhaunen, Rheinland-Pfalz, 55624, Germany|GSK Investigational Site, Speyer, Rheinland-Pfalz, 67346, Germany|GSK Investigational Site, Trier, Rheinland-Pfalz, 54292, Germany|GSK Investigational Site, Trier, Rheinland-Pfalz, 54296, Germany|GSK Investigational Site, Friedrichsthal, Saarland, 66299, Germany|GSK Investigational Site, Saarlouis, Saarland, 66740, Germany|GSK Investigational Site, Sr. Ingbert, Saarland, 66386, Germany|GSK Investigational Site, Athens, 115 26, Greece|GSK Investigational Site, Athens, 115 27, Greece|GSK Investigational Site, Athens, 155 62, Greece|GSK Investigational Site, Athens, 176 74, 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, 400005, India|GSK Investigational Site, New Delhi, 110017, India|GSK Investigational Site, Udine, Friuli-Venezia-Giulia, 33100, Italy|GSK Investigational Site, Rozzano (Mi), Lombardia, 20089, Italy|GSK Investigational Site, Seoul, 110-744, Korea, Republic of|GSK Investigational Site, Seoul, 120-752, Korea, Republic of|GSK Investigational Site, Seoul, 138-736, Korea, Republic of|GSK Investigational Site, Suwon-Si, 443-721, Korea, Republic of|GSK Investigational Site, Riga, LV1002, Latvia|GSK Investigational Site, Guadalajara, Jalisco, 44340, Mexico|GSK Investigational Site, Monterrey, Nuevo León, 64060, Mexico|GSK Investigational Site, Breda, 4818 CK, Netherlands|GSK Investigational Site, Eindhoven, 5623 EJ, Netherlands|GSK Investigational Site, Enschede, 7511JX, Netherlands|GSK Investigational Site, Nieuwegein, 3435 CM, Netherlands|GSK Investigational Site, Rotterdam, 3015 GD, Netherlands|GSK Investigational Site, Rotterdam, 3075 EA, Netherlands|GSK Investigational Site, Zwolle, 8011 JW, Netherlands|GSK Investigational Site, Bialystok, 15-276, Poland|GSK Investigational Site, Kalisz, 62-800, Poland|GSK Investigational Site, Katowice, 40-635, Poland|GSK Investigational Site, Poznan, 60-355, Poland|GSK Investigational Site, Warszawa, 04-628, Poland|GSK Investigational Site, Moscow, 105 229, Russian Federation|GSK Investigational Site, Moscow, 121552, Russian Federation|GSK Investigational Site, Moscow, 123182, Russian Federation|GSK Investigational Site, Alicante, 03010, Spain|GSK Investigational Site, Badalona, 08916, Spain|GSK Investigational Site, Barcelona, 08035, Spain|GSK Investigational Site, Barcelona, 08036, Spain|GSK Investigational Site, Barcelona, 08097, Spain|GSK Investigational Site, Madrid, 28035, Spain|GSK Investigational Site, Malaga, 29010, Spain|GSK Investigational Site, Marid, 28040, Spain|GSK Investigational Site, Murcia, 30120, Spain|GSK Investigational Site, Oviedo, 33006, Spain|GSK Investigational Site, San Juan/Alicante, 03550, Spain|GSK Investigational Site, Göteborg, SE-413 45, Sweden|GSK Investigational Site, Stockholm, SE-171 76, Sweden|GSK Investigational Site, Bangkok, 10330, Thailand|GSK Investigational Site, Chiang Mai, 50200, Thailand |
| URL: | https://clinicaltrials.gov/show/NCT00116831 |
