RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in DiabetesRECORD
Trial overview
Number of participants with cardiovascular death/cardiovascular hospitalisation events
Timeframe: Baseline through End of Study (up to 7.5 years)
Independent Re-adjudication Outcome: Number of participants who died due to any cause
Timeframe: Baseline through End of Study (up to 7.5 years)
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
Timeframe: Baseline through End of Study (up to 7.5 years)
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
Timeframe: Baseline through End of Study (up to 7.5 years)
Independent Re-adjudication Outcome: Number of participants with a CV (or unknown) death, based on original RECORD endpoint definitions
Timeframe: Baseline through End of Study (up to 7.5 years)
Independent Re-adjudication Outcome: Number of participants with a CV (or unknown) death, based on contemporary endpoint definitions
Timeframe: Baseline through End of Study (up to 7.5 years)
Independent Re-adjudication Outcome: Number of participants with an event of myocardial infarction (fatal and non-fatal), based on original RECORD endpoint definitions
Timeframe: Baseline through End of Study (up to 7.5 years)
Independent Re-adjudication Outcome: Number of participants with an event of myocardial infarction (fatal and non-fatal), based on contemporary endpoint definitions
Timeframe: Baseline through End of Study (up to 7.5 years)
Independent Re-adjudication Outcome: Number of participants (par.) with an event of stroke (fatal and non-fatal), based on original RECORD endpoint definitions
Timeframe: Baseline through End of Study (up to 7.5 years)
Independent Re-adjudication Outcome: Number of participants with an event of stroke (fatal and non-fatal), based on contemporary endpoint definitions
Timeframe: Baseline through End of Study (up to 7.5 years)
Number of participants with cardiovascular events and all-cause deaths
Timeframe: Baseline through End of Study (up to 7.5 years)
Total number of cardiovascular hospitalisations and cardiovascular deaths
Timeframe: Baseline through End of Study (up to 7.5 years)
Number of participants with first cardiovascular hospitalisations/cardiovascular deaths by stratum
Timeframe: Baseline through End of Study (up to 7.5 years)
Number of participants with CV/Microvascular Events
Timeframe: Baseline through End of Study (up to 7.5 years)
Number of participants with glycaemic failure events
Timeframe: Baseline through to end of randomised dual therapy
Number of participants with Addition of Third Oral Agent/Switch to Insulin
Timeframe: Baseline through End of Study (up to 7.5 years)
The number of participants starting insulin at any time during the study
Timeframe: Baseline through End of Study (up to 7.5 years)
Model adjusted change from baseline in HbA1c at Month 60
Timeframe: Baseline and Month 60 of randomised dual therapy treatment period
Model adjusted change from Baseline in fasting plasma glucose at Month 60
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment period
Model adjusted mean change from Baseline in insulin and pro-insulin at Month 60
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment period
Number of HbA1c and fasting plasma glucose (FPG) responders at Month 60
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment period
Model adjusted ratio to baseline (expressed as a percentage) Homeostasis Model Assessment (HOMA) Beta cell function and insulin sensitivity at Month 60
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase
Model adjusted ratio to baseline (expressed as a percentage) for total cholesterol (TC), low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides, and free fatty acids (FFAs) at Month 60
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase
Model adjusted ratio to baseline (expressed as a percentage) for total cholesterol (TC):high-density lipoprotein (HDL) cholesterol and low-density lipoprotein (LDL) cholesterol:HDL cholesterol ratios at Month 60
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment period
Model adjusted ratio to Baseline (expressed as a percentage) for Apolipoprotein B (Apo-B) at Month 60
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment period
Model adjusted ratio to baseline (expressed as a percentage) for urinary albumin creatinine ratio at Month 60
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase
Model adjusted change from baseline in body weight at Month 60
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase
Model adjusted change from Baseline in alanine aminotransferase at Month 60
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase
Model adjusted change from baseline in waist circumference at Month 60
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase
Model adjusted change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Month 60
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase
Model adjusted ratio to baseline (expressed as a percentage) for C-Reactive Protein at Month 60
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase
Model adjusted ratio to baseline (expressed as a percentage) for fibrinogen at Month 60
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase
Model adjusted ratio to baseline (expressed as a percentage) for plasminogen activator inhibitor-1 (PAI-1) antigen at Month 60
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase
Number of participants with the indicated type of neoplasm/cancer event reported as a serious adverse event (SAE) or death: Main Study + Observational Follow-up Combined
Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Number of participants with the indicated type of neoplasm/cancer event reported as a serious adverse event (SAE) or death: Observational Follow-up
Timeframe: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Number of participants with the indicated type of malignant neoplasms/cancer events reported as an SAE or death by location (including location of special interest): Main Study + Observational Follow-up Combined
Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Number of participants with the indicated type of malignant neoplasms/cancer events reported as an SAE or death by location (including location of special interest): Observational Follow-up
Timeframe: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Number of participants who died due to the indicated cancer-related event: Main Study + Observational Follow-up Combined
Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Number of participants who died due to the indicated cancer-related event: Observational Follow-up
Timeframe: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Number of participants with a bone fracture event – overall and by gender: Main Study and Observational Follow-up Combined
Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Number of participants with a bone fracture event – overall and by gender: Observational Follow-up
Timeframe: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Number of participants with a bone fracture event reported as the indicated serious adverse event (by higher level group term) or death: Main Study + Observational Follow-up Combined
Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Number of participants with a bone fracture event reported as the indicated serious adverse event (by higher level group term) or death: Observational Follow-up
Timeframe: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Number of participants with an event of death due to a bone fracture-related event: Main Study + Observational Follow-up Combined
Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Number of participants with the indicated bone fracture by fracture site: Main Study + Observational Follow-up Combined
Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Number of participants with the indicated bone fracture by fracture site: Observational Follow-up
Timeframe: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Number of participants with potentially high morbidity fractures: Main Study + Observational Follow-up Combined
Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Number of participants with potentially high morbidity fracture events and non-high morbidity fracture events, in participants with prior hand/upper arm/foot fractures (H/UA/FF): Main Study + Observational Follow-up Combined
Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Number of participants with bone fracture events of the indicated cause: Main Study + Observational Follow-up Combined
Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Number of participants with bone fracture events of the indicated cause: Observational Follow-up
Timeframe: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Number of bone fracture events with the indicated outcome: Main Study + Observational Follow-up Combined
Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Number of bone fracture events with the indicated outcome: Observational Follow-up
Timeframe: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Number of participants with the indicated serious adverse event: Observational Follow-up
Timeframe: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Participation criteria
- Patients with type II diabetes mellitus as defined by 1999 World Health Organisation criteria.
- Glycated haemoglobin (HbA1c) >7.0 % to = 9.0 % at visit 1.
- Patients receiving any other glucose lowering therapy which is not metformin or a sulfonylurea.
- Patients with systolic blood pressure >180 mmHg or diastolic blood pressure >105 mmHg.
- Patients with type II diabetes mellitus as defined by 1999 World Health Organisation criteria.
- Glycated haemoglobin (HbA1c) >7.0 % to = 9.0 % at visit 1.
- Use of an oral glucose lowering agent for a minimum of 6 months prior to screening and unchanged for 2 months prior to screening.
- Body mass index >25.0 kg/m2.
- Patients receiving any other glucose lowering therapy which is not metformin or a sulfonylurea.
- Patients with systolic blood pressure >180 mmHg or diastolic blood pressure >105 mmHg.
- Patients who have required the use of insulin for glycaemic control at any time in the past.
- Hospitalisation for any major cardiovascular event in the last 3 months.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.