Trial · NCT00379769
RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes
NCT00379769, Phase 3, Completed, GlaxoSmithKline; results first posted 2009-11-13
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes. Trials, record NCT00379769. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00379769
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes
- NCT number
- NCT00379769
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,447 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Rosiglitazone, Sulfonylurea, Metformin
- First posted
- 2006-09-22
- Last updated
- 2017-03-23
- Results first posted
- 2009-11-13
Source ClinicalTrials.gov
Registered outcomes53
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Cardiovascular Death/Cardiovascular Hospitalisation Events | Baseline through End of Study (up to 7.5 years) | The number of participants with cardiovascular death events (death due to cardiovascular causes or deaths with insufficient information to rule out a cardiovascular cause) and cardiovascular hospitalisation events (hospitalisation for a cardiovascular event, excluding planned admissions not associated with a worsening of the disease/condition of the participant) was recorded. |
| Primary | Independent Re-adjudication Outcome: Number of Participants Who Died Due to Any Cause | Baseline through End of Study (up to 7.5 years) | All deaths identified during the original record study and discovered after the re-adjudication efforts began were included. |
| Primary | Independent Re-adjudication (IR) Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Original RECORD Endpoint Definitions | Baseline through End of Study (up to 7.5 years) | IR was based on original RECORD endpoint definitions. CV death= no unequivocal non-CV cause (sudden death, death from acute vascular events, heart failure, acute MI, other CV causes, and deaths adjudicated as unknown cause). MI event=hospitalization + elevation of specific cardiac biomarkers above the upper limit of normal + cardiac ischemia symptoms/new pathological electrocardiogram findings. Stroke event=hospitalization + rapidly developed clinical signs of focal/global disturbance of cerebral function for more than 24 hours, with no apparent cause other than a vascular origin. |
| Primary | Independent Re-adjudication Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Contemporary Endpoint Definitions | Baseline through End of Study (up to 7.5 years) | Independent re-adjudication was based on the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions. CV death included death resulting from an acute MI; sudden cardiac death and death due to heart failure, stroke, and to other CV causes. Deaths of unknown cause were counted as CV deaths. MI was defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Stroke was defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury. |
| Primary | Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Original RECORD Endpoint Definitions | Baseline through End of Study (up to 7.5 years) | The number of participants with a CV death (or unknown) as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. CV death was defined as any death for which an unequivocal non-CV cause could not be established. CV death included death following heart failure, death following acute myocardial infarction (MI), sudden death, death due to acute vascular events, and other CV causes. Deaths due to unknown causes were classified as "unknown deaths," but were counted as CV deaths for the analysis of this endpoint. |
| Primary | Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Contemporary Endpoint Definitions | Baseline through End of Study (up to 7.5 years) | The number of participants with a CV (or unknown) death as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. CV death included death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, and death due to other CV causes. Deaths of unknown cause were counted as CV deaths. |
| Primary | Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions | Baseline through End of Study (up to 7.5 years) | The number of participants with an MI (fatal or non-fatal) event as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. An event of MI was defined as hospitalization plus elevation of cardiac biomarkers troponin (TN) I and/or TNT above the upper limit of normal (ULN) or creatinine kinase (CK) MB (M=muscle type; B=brain type) isoenzyme \>= 2x the ULN or CK \> 2x the ULN plus typical symptoms of cardiac ischemia or new pathological electrocardiogram findings, or cause of death adjudicated as MI. |
| Primary | Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions | Baseline through End of Study (up to 7.5 years) | The number of participants with an MI (fatal or non-fatal) event as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. An event of MI was defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. |
| Primary | Independent Re-adjudication Outcome: Number of Participants (Par.) With an Event of Stroke (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions | Baseline through End of Study (up to 7.5 years) | Par. with a stroke (fatal or non-fatal) event as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. A stroke event=hospitalization plus rapidly developed clinical signs of focal (or global) disturbance of cerebral function lasting more than 24 hours (unless interrupted by thrombolysis, surgery, or death), with no apparent cause other than a vascular origin, including par. presenting clinical signs/symptoms suggestive of subarachnoid haemorrhage/intracerebral haemorrhage/cerebral ischemic necrosis or cause of death adjudicated as stroke. |
| Primary | Independent Re-adjudication Outcome: Number of Participants With an Event of Stroke (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions | Baseline through End of Study (up to 7.5 years) | The number of participants with a stroke (fatal or non-fatal) event as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. An event of stroke was defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury. |
1 to 10 of 53Source ClinicalTrials.gov
See all 53 registered outcomesOutcomes53
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Cardiovascular Death/Cardiovascular Hospitalisation Events | Baseline through End of Study (up to 7.5 years) | Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication | participants | NUMBER |
| SECONDARY | Number of Participants With Cardiovascular Events and All-cause Deaths | Baseline through End of Study (up to 7.5 years) | Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication | participants | NUMBER |
| SECONDARY | Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths | Baseline through End of Study (up to 7.5 years) | Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication | Number of events | NUMBER |
| SECONDARY | Number of Participants With First Cardiovascular Hospitalisations/Cardiovascular Deaths by Stratum | Baseline through End of Study (up to 7.5 years) | Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication | partcipants | NUMBER |
| SECONDARY | Number of Participants With CV/Microvascular Events | Baseline through End of Study (up to 7.5 years) | Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication | participants | NUMBER |
| SECONDARY | Number of Participants With Glycaemic Failure Events | Baseline through to end of randomised dual therapy | Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication | participants | NUMBER |
| SECONDARY | Number of Participants With Addition of Third Oral Agent/Switch to Insulin | Baseline through End of Study (up to 7.5 years) | Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication | participants | NUMBER |
| SECONDARY | The Number of Participants Starting Insulin at Any Time During the Study | Baseline through End of Study (up to 7.5 years) | Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication | participants | NUMBER |
| SECONDARY | Model Adjusted Change From Baseline in HbA1c at Month 60 | Baseline and Month 60 of randomised dual therapy treatment period | Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication | Percent | MEAN |
| SECONDARY | Model Adjusted Change From Baseline in Fasting Plasma Glucose at Month 60 | Baseline to Month 60 of the randomised dual therapy treatment period | Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication | mmol/L (millimoles/Liter) | MEAN |
1 to 10 of 53Source ClinicalTrials.gov
See all 53 outcomesResults by group870
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Cardiovascular Death/Cardiovascular Hospitalisation Events | Combined RSG | 321 | participants | ||
| Number of Participants With Cardiovascular Death/Cardiovascular Hospitalisation Events | Combined MET/SU | 323 | participants | ||
| Number of Participants With Cardiovascular Events and All-cause Deaths | Combined RSG | CV death, acute MI, stroke | 154 | participants | |
| Number of Participants With Cardiovascular Events and All-cause Deaths | Combined MET/SU | CV death, acute MI, stroke | 165 | participants | |
| Number of Participants With Cardiovascular Events and All-cause Deaths | Combined RSG | CV death, acute MI, stroke, unstable angina | 171 | participants | |
| Number of Participants With Cardiovascular Events and All-cause Deaths | Combined MET/SU | CV death, acute MI, stroke, unstable angina | 184 | participants | |
| Number of Participants With Cardiovascular Events and All-cause Deaths | Combined RSG | CV death, acute MI, stroke, unstable angina, CHF | 204 | participants | |
| Number of Participants With Cardiovascular Events and All-cause Deaths | Combined MET/SU | CV death, acute MI, stroke, unstable angina, CHF | 206 | participants | |
| Number of Participants With Cardiovascular Events and All-cause Deaths | Combined RSG | All-cause death,acuteMI,stroke,unstable angina,CHF | 251 | participants | |
| Number of Participants With Cardiovascular Events and All-cause Deaths | Combined MET/SU | All-cause death,acuteMI,stroke,unstable angina,CHF | 268 | participants |
1 to 10 of 870Source ClinicalTrials.gov
See all 870 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Main Study | STARTED | RSG in Addition to Background MET | 1,117 | |
| Main Study | STARTED | SU in Addition to Background MET | 1,105 | |
| Main Study | STARTED | RSG in Addition to Background SU | 1,103 | |
| Main Study | STARTED | MET in Addition to Background SU | 1,122 | |
| Main Study | STARTED | Combined RSG: Observational Follow-up | 0 | |
| Main Study | STARTED | Combined MET/SU: Observational Follow-up | 0 | |
| Main Study | COMPLETED | RSG in Addition to Background MET | 939 | |
| Main Study | COMPLETED | SU in Addition to Background MET | 906 | |
| Main Study | COMPLETED | RSG in Addition to Background SU | 896 | |
| Main Study | COMPLETED | MET in Addition to Background SU | 892 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events5,184
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 | Hypertension | Vascular disorders | RSG in Addition to Background MET | 345 | 1,117 | |
| other | Hypertension | Vascular disorders | SU in Addition to Background MET | 372 | 1,105 | |
| other | Hypertension | Vascular disorders | RSG in Addition to Background SU | 302 | 1,103 | |
| other | Hypertension | Vascular disorders | MET in Addition to Background SU | 319 | 1,122 | |
| other | Hypertension | Vascular disorders | Combined RSG: Observational Follow-up | 0 | 1,280 | |
| other | Hypertension | Vascular disorders | Combined MET/SU: Observational Follow-up | 0 | 1,250 | |
| other | Nasopharyngitis | Infections and infestations | RSG in Addition to Background MET | 216 | 1,117 | |
| other | Nasopharyngitis | Infections and infestations | SU in Addition to Background MET | 202 | 1,105 | |
| other | Nasopharyngitis | Infections and infestations | RSG in Addition to Background SU | 121 | 1,103 | |
| other | Nasopharyngitis | Infections and infestations | MET in Addition to Background SU | 122 | 1,122 |
1 to 10 of 5,184Source ClinicalTrials.gov
See all 5,184 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RSG in Addition to Background MET | ||
| Total, all-cause mortality | SU in Addition to Background MET | ||
| Total, all-cause mortality | RSG in Addition to Background SU | ||
| Total, all-cause mortality | MET in Addition to Background SU | ||
| Total, all-cause mortality | Combined RSG: Observational Follow-up | ||
| Total, all-cause mortality | Combined MET/SU: Observational Follow-up | ||
| Total, other adverse events | RSG in Addition to Background MET | 1,117 | 1,117 |
| Total, other adverse events | SU in Addition to Background MET | 1,105 | 1,105 |
| Total, other adverse events | RSG in Addition to Background SU | 1,103 | 1,103 |
| Total, other adverse events | MET in Addition to Background SU | 1,122 | 1,122 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers7
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 comparisons11
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Combined RSG vs Combined MET/SU: Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Contemporary Endpoint Definitions | Trial comparisons |
| Combined RSG vs Combined MET/SU: Independent Re-adjudication Outcome: Number of Participants (Par.) With an Event of Stroke (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions | Trial comparisons |
| Combined RSG vs Combined MET/SU: Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Original RECORD Endpoint Definitions | Trial comparisons |
| Combined RSG vs Combined MET/SU: Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions | Trial comparisons |
Combined RSG vs Combined MET/SU: Independent Re-adjudication Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Contemporary Endpoint Definitions | Trial comparisons |
Combined RSG vs Combined MET/SU: Independent Re-adjudication (IR) Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Original RECORD Endpoint Definitions | Trial comparisons |
| Combined RSG vs Combined MET/SU: Number of Participants With Cardiovascular Death/Cardiovascular Hospitalisation Events | Trial comparisons |
| Combined RSG vs Combined MET/SU: Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions | Trial comparisons |
| Combined RSG vs Combined MET/SU: Independent Re-adjudication Outcome: Number of Participants Who Died Due to Any Cause | Trial comparisons |
Combined RSG: Main Study and Observational Follow-up vs Combined MET/SU: Main Study and Observational Follow-up: Number of Participants With an Event of Death Due to a Bone Fracture-related Event: Main Study + Observational Follow-up Combined | Trial comparisons |
1 to 10 of 11
See all 11 trial comparisonsTests0
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/NCT00379769
GET https://conductscience.org/api/trials/v1/NCT00379769/registered?page=2