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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glipizide | Active Comparator | oral anti-diabetic medication |
|
| rosiglitazone maleate | Experimental | oral anti-diabetic medication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glipizide | Drug | oral anti-diabetic medication |
| |
| rosiglitazone maleate |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria:
Diet and exercise only (drug naïve), with HbA1c >7.0 and £ 10.0%. HbA1c > 6.5 and <= 8.5%.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35235 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21359834 | Background | 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. | |
| Background | 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). | ||
| Background | Nesto RW. Effect of rosiglitazone versus glipizide on progression of coronary atherosclerosis in patients with type 2 diabetes and coronary artery disease. American Heart Association Scientific Sessions. November 12, 2008, New Orleans, LA. (http://directnews.americanheart.org/extras/pdfs/approach_slides.pdf) |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| AVD100521 | Dataset Specification | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Glipizide (GLP) 5 mg | Glipizide (GLP) 5 mg once daily for 18 months |
| FG001 | Rosiglitazone (RSG) 4 mg | Rosiglitazone (RSG) 4 mg once daily for 18 months |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
oral antidiabetic medication |
|
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 |
| Scottsdale |
| Arizona |
| 85251 |
| United States |
| GSK Investigational Site | Tucson | Arizona | 85745 | United States |
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| GSK Investigational Site | Dortmund | North Rhine-Westphalia | 44328 | Germany |
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| GSK Investigational Site | Duisburg | North Rhine-Westphalia | 47119 | Germany |
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| GSK Investigational Site | Essen | North Rhine-Westphalia | 45309 | Germany |
| GSK Investigational Site | Essen | North Rhine-Westphalia | 45329 | Germany |
| GSK Investigational Site | Essen | North Rhine-Westphalia | 45355 | Germany |
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| GSK Investigational Site | Herne | North Rhine-Westphalia | 44623 | Germany |
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| GSK Investigational Site | Gothenburg | SE-413 45 | Sweden |
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| 19033001 | Background | Ratner RE, Cannon CP, Gerstein HC, Nesto RW, Serruys PW, Van Es GA, Kolatkar NS, Kravitz BG, Zalewski A, Fitzgerald PJ; APPROACH Study Group. Assessment on the Prevention of Progression by Rosiglitazone on Atherosclerosis in diabetes patients with Cardiovascular History (APPROACH): study design and baseline characteristics. Am Heart J. 2008 Dec;156(6):1074-9. doi: 10.1016/j.ahj.2008.07.025. Epub 2008 Oct 11. |
| 20194881 | Derived | 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. |
For additional information about this study please refer to the GSK Clinical Study Register |
| AVD100521 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AVD100521 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AVD100521 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AVD100521 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AVD100521 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AVD100521 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Glipizide (GLP) 5 mg | Glipizide (GLP) 5 mg once daily for 18 months |
| BG001 | Rosiglitazone (RSG) 4 mg | Rosiglitazone (RSG) 4 mg once daily for 18 months |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
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| Pre-study Treatment | Pre-study treatment in the Safety Population | Number | Participants |
| |||||||||||||||
| Smoking history | Smoking history in the Safety Population | Number | Participants |
| |||||||||||||||
| Body Mass Index (BMI) | Median BMI in the Safety Population | Median | Full Range | kilograms per square meter (kg/m2) |
| ||||||||||||||
| Duration of cardiovascular disease | Duration of cardiovascular disease in the Safety Population | Mean | Full Range | Years |
| ||||||||||||||
| Duration of diabetes | Duration of diabetes in the Safety Population | Median | Full Range | Years |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | IVUS Evaluable Population | Posted | Mean | Standard Deviation | millimeters cubed (mm3) | Baseline to Month 18 |
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| Secondary | 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. | IVUS Evaluable Population | Posted | Mean | Standard Error | millimeters cubed (mm3) | Baseline to Month 18 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | IVUS Evaluable Population | Posted | Mean | Standard Error | millimeters cubed (mm3) | Baseline to Month 18 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | IVUS Evaluable Population | Posted | Mean | Standard Error | millimeters cubed (mm3) | Baseline to Month 18 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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 | IVUS Evaluable Population | Posted | Mean | Standard Deviation | millimeters squared (mm2) | Baseline to Month 18 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | IVUS Evaluable Population | Posted | Mean | Standard Error | millimeters square (mm2) | Baseline to Month 18 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | IVUS Evaluable Population | Posted | Mean | Standard Error | millimeters square (mm2) | Baseline to Month 18 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | IVUS Evaluable Population | Posted | Mean | Standard Error | millimeters square (mm2) | Baseline to Month 18 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | IVUS Evaluable Population | Posted | Mean | Standard Deviation | millimeters cubed (mm3) | Baseline to Month 18 |
|
| ||||||||||||||||||||||||||||||||||||
| 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. | IVUS Evaluable Population (Defined as all randomized participants who received at least one dose of study medication, with an evaluable Baseline and exit [≥ 9 months] IVUS imaging assessment.) | Posted | Mean | Standard Deviation | percent (absolute change) | Baseline to Month 18 |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | 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). | IVUS Evaluable Population (Defined as all randomized participants who received at least one dose of study medication, with an evaluable Baseline and exit [≥ 9 months] IVUS imaging assessment.) | Posted | Mean | Standard Error | percent (absolute change) | Baseline to Month 18 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | IVUS Evaluable Population | Posted | Mean | Standard Error | millimeters cubed (mm3) | Baseline to Month 18 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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 | IVUS Evaluable Population with last observation carried forward (LOCF) | Posted | Mean | Standard Deviation | millimeters cubed (mm3) | Baseline to Month 18 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | IVUS Evaluable Population with last observation carried forward (LOCF) | Posted | Mean | Standard Error | millimeters cubed (mm3) | Baseline to Month 18 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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 | IVUS Evaluable Population with last observation carried forward (LOCF) | Posted | Mean | Standard Deviation | millimeters squared (mm2) | Baseline to Month 18 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | IVUS Evaluable Population with last observation carried forward (LOCF) | Posted | Mean | Standard Error | millimeters squared (mm2) | Baseline to Month 18 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intent-to-Treat (ITT) Population without Last Observation Carried Forward (LOCF). ITT population was defined as all participants in the study who were randomized and have at least one on-therapy value for an efficacy assessment. | Posted | Mean | Standard Error | Percentage | Baseline to Month 18 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population without LOCF | Posted | Mean | Standard Error | millimole/Liter (mmol/L) | Baseline to Month 18 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population without LOCF | Posted | Number | percent change | Baseline to Month 18 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population without LOCF | Posted | Number | percent change | Baseline to Month 18 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population with LOCF | Posted | Number | percent change | Baseline to Month 18 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population with LOCF | Posted | Number | percent change | Baseline to Month 18 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population without LOCF | Posted | Number | percent change | Baseline to Month 18 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population without LOCF | Posted | Number | percent change | Baseline to Month 18 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population without LOCF | Posted | Number | percent change | Baseline to Month 18 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population without LOCF | Posted | Number | percent change | Baseline to Month 18 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population without LOCF | Posted | Number | percent change | Baseline to Month 18 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population without LOCF | Posted | Number | percent change | Baseline to Month 18 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population without LOCF | Posted | Number | percent change | Baseline to Month 18 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population without LOCF | Posted | Number | percent change | Baseline to Month 18 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population without LOCF | Posted | Mean | Standard Error | Ratio | Baseline to Month 18 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population without LOCF | Posted | Mean | Standard Error | ratio | Baseline to Month 18 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population without LOCF | Posted | Mean | Standard Error | ratio | Baseline to Month 18 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Safety Population | Posted | Number | Participants | Baseline to Month 21 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Safety Population | Posted | Number | Participants | Baseline to Month 21 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Other Cardiovascular Events | This was one of the secondary endpoints of the study. | Safety Population | Posted | Number | Number of events | Baseline to Month 21 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Glipizide (GLP) 5 mg | Glipizide (GLP) 5 mg once daily for 18 months | 71 | 337 | 117 | 337 | ||
| EG001 | Rosiglitazone (RSG) 4 mg | Rosiglitazone (RSG) 4 mg once daily for 18 months | 71 | 331 | 98 | 331 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiovascular disorder | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Congestive cardiomyopathy | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Prinzmetal angina | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Death | General disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Ill-defined disorder | General disorders | MedDRA | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA | Systematic Assessment |
| |
| Vessel puncture site haemorrhage | General disorders | MedDRA | Systematic Assessment |
| |
| In-stent arterial restenosis | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Post procedural myocardial infarction | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Chest injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| In-stent coronary artery restenosis | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Muscle injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Post procedural swelling | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Postoperative thrombosis | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Therapeutic agent toxicity | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Constipation | General disorders | MedDRA | Systematic Assessment |
| |
| Dyspepsia | General disorders | MedDRA | Systematic Assessment |
| |
| Enteritis | General disorders | MedDRA | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | General disorders | MedDRA | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Umbilical hernia | General disorders | MedDRA | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Brain stem infarction | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cerebral artery embolism | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Syncope vasovagal | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Diabetic nephropathy | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Nephroangiosclerosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Benign neoplasm of thyroid gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Breast cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Biliary tract disorder | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Hepatitis toxic | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Adjustment disorder with mixed disturbance of emotion and cond | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Macular hole | Eye disorders | MedDRA | Systematic Assessment |
| |
| Cardiac enzymes increased | Investigations | MedDRA | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Edema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D058226 | Plaque, Atherosclerotic |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D005913 | Glipizide |
| D000077154 | Rosiglitazone |
| ID | Term |
|---|---|
| D013453 | Sulfonylurea Compounds |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
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| Oriental |
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| Black |
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| Mixed race |
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| Missing |
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| American Indian/Alaska native |
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| Oral anti-diabetic monotherapy |
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| Oral anti-diabetic dual therapy |
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| Current smoker |
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| Former smoker |
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| Missing |
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| Change from Baseline in Atheroma Volume |
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| Vessel Volume, Baseline |
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| Vessel Volume, Month 18 |
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| Change from Baseline in Vessel Volume |
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| Lumen Volume, Baseline |
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| Lumen Volume, Month 18 |
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| Change from Baseline in Lumen Volume |
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