Trial · NCT00116831
Rosiglitazone Versus a Sulfonylurea On Progression Of Atherosclerosis In Patients With Heart Disease And Type 2 Diabetes
NCT00116831, Phase 3, Completed, GlaxoSmithKline; results first posted 2010-03-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Rosiglitazone Versus a Sulfonylurea On Progression Of Atherosclerosis In Patients With Heart Disease And Type 2 Diabetes. Trials, record NCT00116831. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00116831
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rosiglitazone Versus a Sulfonylurea On Progression Of Atherosclerosis In Patients With Heart Disease And Type 2 Diabetes
- NCT number
- NCT00116831
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 672 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Atherosclerosis
- Interventions
- Glipizide, rosiglitazone maleate
- First posted
- 2005-07-01
- Last updated
- 2017-03-23
- Results first posted
- 2010-03-31
Source ClinicalTrials.gov
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Percent Atheroma Volume (PAV) to Month 18 | 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. |
| Primary | Model Adjusted Change From Baseline in Percent Atheroma Volume (PAV) to Month 18 | Baseline to Month 18 | Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior Oral Anti-Hyperglycemic Diabetic Medications(s) (OAD). |
| Secondary | Change From Baseline in Atheroma, Vessel, and Lumen Volume to Month 18 | Baseline to Month 18 | IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18 |
| Secondary | Model Adjusted Change From Baseline in Atheroma Volume to Month 18 | 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. |
| Secondary | Model Adjusted Change From Baseline in Lumen Volume to Month 18 | 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. |
| Secondary | Model Adjusted Change From Baseline in Vessel Volume to Month 18 | 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. |
| Secondary | Change From Baseline in Atheroma, Vessel, and Lumen Area to Month 18 | Baseline to Month 18 | IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18 |
| Secondary | Model Adjusted Change From Baseline in Atheroma Area to Month 18 | 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. |
| Secondary | Model Adjusted Change From Baseline in Lumen Area to Month 18 | 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. |
| Secondary | Model Adjusted Change From Baseline in Vessel Area to Month 18 | 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. |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 registered outcomesOutcomes36
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Change From Baseline in Atheroma, Vessel, and Lumen Volume to Month 18 | Baseline to Month 18 | IVUS Evaluable Population | millimeters cubed (mm3) | MEAN |
| SECONDARY | Model Adjusted Change From Baseline in Atheroma Volume to Month 18 | Baseline to Month 18 | IVUS Evaluable Population | millimeters cubed (mm3) | MEAN |
| SECONDARY | Model Adjusted Change From Baseline in Lumen Volume to Month 18 | Baseline to Month 18 | IVUS Evaluable Population | millimeters cubed (mm3) | MEAN |
| SECONDARY | Model Adjusted Change From Baseline in Vessel Volume to Month 18 | Baseline to Month 18 | IVUS Evaluable Population | millimeters cubed (mm3) | MEAN |
| SECONDARY | Change From Baseline in Atheroma, Vessel, and Lumen Area to Month 18 | Baseline to Month 18 | IVUS Evaluable Population | millimeters squared (mm2) | MEAN |
| SECONDARY | Model Adjusted Change From Baseline in Atheroma Area to Month 18 | Baseline to Month 18 | IVUS Evaluable Population | millimeters square (mm2) | MEAN |
| SECONDARY | Model Adjusted Change From Baseline in Lumen Area to Month 18 | Baseline to Month 18 | IVUS Evaluable Population | millimeters square (mm2) | MEAN |
| SECONDARY | Model Adjusted Change From Baseline in Vessel Area to Month 18 | Baseline to Month 18 | IVUS Evaluable Population | millimeters square (mm2) | MEAN |
| SECONDARY | Change From Baseline in Normalized Atheroma Volume | Baseline to Month 18 | IVUS Evaluable Population | millimeters cubed (mm3) | MEAN |
| PRIMARY | Change From Baseline in Percent Atheroma Volume (PAV) to Month 18 | Baseline to Month 18 | 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.) | percent (absolute change) | MEAN |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 outcomesResults by group180
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Atheroma, Vessel, and Lumen Volume to Month 18 | Glipizide (GLP) 5 mg | Atheroma Volume, Baseline | 249.747 | Standard Deviation 150.4095 | millimeters cubed (mm3) |
| Change From Baseline in Atheroma, Vessel, and Lumen Volume to Month 18 | Rosiglitazone (RSG) 4 mg | Atheroma Volume, Baseline | 222.431 | Standard Deviation 137.4193 | millimeters cubed (mm3) |
| Change From Baseline in Atheroma, Vessel, and Lumen Volume to Month 18 | Glipizide (GLP) 5 mg | Atheroma Volume, Month 18 | 249.625 | Standard Deviation 149.7098 | millimeters cubed (mm3) |
| Change From Baseline in Atheroma, Vessel, and Lumen Volume to Month 18 | Rosiglitazone (RSG) 4 mg | Atheroma Volume, Month 18 | 218.576 | Standard Deviation 134.3462 | millimeters cubed (mm3) |
| Change From Baseline in Atheroma, Vessel, and Lumen Volume to Month 18 | Glipizide (GLP) 5 mg | Change from Baseline in Atheroma Volume | -0.123 | Standard Deviation 28.1627 | millimeters cubed (mm3) |
| Change From Baseline in Atheroma, Vessel, and Lumen Volume to Month 18 | Rosiglitazone (RSG) 4 mg | Change from Baseline in Atheroma Volume | -3.854 | Standard Deviation 25.8846 | millimeters cubed (mm3) |
| Change From Baseline in Atheroma, Vessel, and Lumen Volume to Month 18 | Glipizide (GLP) 5 mg | Vessel Volume, Baseline | 609.378 | Standard Deviation 311.7587 | millimeters cubed (mm3) |
| Change From Baseline in Atheroma, Vessel, and Lumen Volume to Month 18 | Rosiglitazone (RSG) 4 mg | Vessel Volume, Baseline | 555.062 | Standard Deviation 297.9848 | millimeters cubed (mm3) |
| Change From Baseline in Atheroma, Vessel, and Lumen Volume to Month 18 | Glipizide (GLP) 5 mg | Vessel Volume, Month 18 | 603.088 | Standard Deviation 304.3434 | millimeters cubed (mm3) |
| Change From Baseline in Atheroma, Vessel, and Lumen Volume to Month 18 | Rosiglitazone (RSG) 4 mg | Vessel Volume, Month 18 | 547.186 | Standard Deviation 298.2100 | millimeters cubed (mm3) |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Glipizide (GLP) 5 mg | 337 | |
| Overall Study | STARTED | Rosiglitazone (RSG) 4 mg | 331 | |
| Overall Study | COMPLETED | Glipizide (GLP) 5 mg | 264 | |
| Overall Study | COMPLETED | Rosiglitazone (RSG) 4 mg | 259 | |
| Overall Study | NOT COMPLETED | Glipizide (GLP) 5 mg | 73 | |
| Overall Study | NOT COMPLETED | Rosiglitazone (RSG) 4 mg | 72 |
Source ClinicalTrials.gov
Adverse events272
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Angina pectoris | Cardiac disorders | Glipizide (GLP) 5 mg | 33 | 337 | |
| other | Angina pectoris | Cardiac disorders | Rosiglitazone (RSG) 4 mg | 31 | 331 | |
| other | Edema peripheral | General disorders | Glipizide (GLP) 5 mg | 24 | 337 | |
| other | Edema peripheral | General disorders | Rosiglitazone (RSG) 4 mg | 29 | 331 | |
| other | Hypertension | Vascular disorders | Glipizide (GLP) 5 mg | 21 | 337 | |
| other | Hypertension | Vascular disorders | Rosiglitazone (RSG) 4 mg | 13 | 331 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Glipizide (GLP) 5 mg | 20 | 337 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Rosiglitazone (RSG) 4 mg | 13 | 331 | |
| other | Dizziness | Nervous system disorders | Glipizide (GLP) 5 mg | 17 | 337 | |
| other | Dizziness | Nervous system disorders | Rosiglitazone (RSG) 4 mg | 16 | 331 |
1 to 10 of 272Source ClinicalTrials.gov
See all 272 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Glipizide (GLP) 5 mg | ||
| Total, all-cause mortality | Rosiglitazone (RSG) 4 mg | ||
| Total, other adverse events | Glipizide (GLP) 5 mg | 117 | 337 |
| Total, other adverse events | Rosiglitazone (RSG) 4 mg | 98 | 331 |
| Total, serious adverse events | Glipizide (GLP) 5 mg | 71 | 337 |
| Total, serious adverse events | Rosiglitazone (RSG) 4 mg | 71 | 331 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Glipizide (GLP) 5 mg vs Rosiglitazone (RSG) 4 mg: 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) | Trial comparisons |
Glipizide (GLP) 5 mg vs Rosiglitazone (RSG) 4 mg: Number of Participants With the Indicated Treatment Emergent Major Cardiovascular Events (MACE) for Cardiovascular Death, Nonfatal MI, or Nonfatal Stroke (MACE Composite 2) | Trial comparisons |
| Glipizide (GLP) 5 mg vs Rosiglitazone (RSG) 4 mg: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00116831
GET https://conductscience.org/api/trials/v1/NCT00116831/registered?page=2