Last updated: 11/07/2018 15:59:14

RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in DiabetesRECORD

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GSK study ID
BRL-049653/231
See study documents
Clinicaltrials.gov ID
NCT00379769
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A long term, open label, randomised study in patients with type 2 diabetes, comparing the combination of rosiglitazone and either metformin or sulfonylurea with metformin plus sulfonylurea on cardiovascular endpoints and glycaemia
Trial description: This study is a phase 3b, multicentre, randomised, open label, parallel group study. A 4-week run-in period will be followed by a median of 6 years of treatment with study medication in addition to continuation of background glucose lowering therapy. Patients inadequately controlled on background metformin will be randomised to receive, in addition to metformin, either rosiglitazone or a sulfonylurea(glibenclamide, gliclazide or glimepiride) in a ratio of 1:1. Patients inadequately controlled on background SU will be randomised to receive, in addition to SU, either rosiglitazone or metformin in a ratio of 1:1. Equal numbers of patients receiving background metformin and SU at entry will be entered into the study.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

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)

Secondary outcomes:

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)

Interventions:
  • Drug: Rosiglitazone
  • Drug: Sulfonylurea
  • Drug: Metformin
    • Enrollment:
    4447
    Primary completion date:
    2008-26-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Home PD, Jones NP, Pocock SJ et al. Diabetic Medicine 200724: 626-634.
    Home PD, Pocock SJ, Beck-Nielsen H et al. Diabetologia 2005;48:1726-1735.
    Home PD, Pocock SJ, Beck-Nielsen H et al. N Engl J Med 2007;357:28-38.
    Home PD, Pocock SJ, Beck-Nielsen H et al. The Lancet 2009; 373:2125-2135.
    Komajda M, Curtis P, Hanefeld M et al. Cardiovascular Diabetology 2008;7:10.
    Jones P, Curtis P, Home P.Cancer and bone fractures in observational follow up of the RECORD study.Acta Diabetologica.2015;52(3):539-546
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    rosiglitazone
    Collaborators
    Not applicable
    Study date(s)
    April 2001 to Invalid Date
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    40 - 75 years
    Accepts healthy volunteers
    No
    • 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.
    Inclusion and exclusion criteria
    Inclusion 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.
    • 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.
    Exclusion criteria:
    • 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)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Lucenec, Slovakia, 984 01
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Brussels, Belgium, 1090
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pinsaguel, France, 31120
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tauranga, New Zealand, 3112
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Wuerzburg, Bayern, Germany, 97070
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tallinn, Estonia, 10138
    Status
    Study Complete
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    Showing 1 - 6 of 433 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2008-26-12
    Actual study completion date
    Not applicable

    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.

    Additional information about the trial

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