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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00379769
First received: September 21, 2006
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Rosiglitazone
Drug: Sulfonylurea
Drug: Metformin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Participants With Cardiovascular Death/Cardiovascular Hospitalisation Events [ Time Frame: Baseline through End of Study (up to 7.5 years) ] [ Designated as safety issue: No ]
    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.

  • Independent Re-adjudication Outcome: Number of Participants Who Died Due to Any Cause [ Time Frame: Baseline through End of Study (up to 7.5 years) ] [ Designated as safety issue: No ]
    All deaths identified during the original record study and discovered after the re-adjudication efforts began were included.

  • 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 [ Time Frame: Baseline through End of Study (up to 7.5 years) ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline through End of Study (up to 7.5 years) ] [ Designated as safety issue: No ]
    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.

  • Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Original RECORD Endpoint Definitions [ Time Frame: Baseline through End of Study (up to 7.5 years) ] [ Designated as safety issue: No ]
    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.

  • Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Contemporary Endpoint Definitions [ Time Frame: Baseline through End of Study (up to 7.5 years) ] [ Designated as safety issue: No ]
    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.

  • Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions [ Time Frame: Baseline through End of Study (up to 7.5 years) ] [ Designated as safety issue: No ]
    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.

  • Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions [ Time Frame: Baseline through End of Study (up to 7.5 years) ] [ Designated as safety issue: No ]
    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.

  • Independent Re-adjudication Outcome: Number of Participants (Par.) With an Event of Stroke (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions [ Time Frame: Baseline through End of Study (up to 7.5 years) ] [ Designated as safety issue: No ]
    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.

  • Independent Re-adjudication Outcome: Number of Participants With an Event of Stroke (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions [ Time Frame: Baseline through End of Study (up to 7.5 years) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Participants With Cardiovascular Events and All-cause Deaths [ Time Frame: Baseline through End of Study (up to 7.5 years) ] [ Designated as safety issue: No ]
    Composites of participants with first cardiovascular (CV) hospitalisations and CV death or all-cause death and individual first events of acute myocardial infarction (MI) , stroke, congestive heart failure (CHF), CV death, and all-cause death.

  • Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths [ Time Frame: Baseline through End of Study (up to 7.5 years) ] [ Designated as safety issue: No ]
    The total number of events for individual components of cardiovascular (CV) hospitalisations and cardiovascular deaths were recorded. MI, myocardial infarction.

  • Number of Participants With First Cardiovascular Hospitalisations/Cardiovascular Deaths by Stratum [ Time Frame: Baseline through End of Study (up to 7.5 years) ] [ Designated as safety issue: No ]
    Participants with first cardiovascular death (death due to cardiovascular causes or deaths with insufficient information to rule out a cardiovascular cause) and cardiovascular hospitalisation (hospitalisation for a cardiovascular event, excluding planned admissions not associated with a worsening of the disease/condition of the participant) were recorded by study stratum.

  • Number of Participants With CV/Microvascular Events [ Time Frame: Baseline through End of Study (up to 7.5 years) ] [ Designated as safety issue: No ]
    The number of participants with first cardiovascular or microvascular events (renal, foot, eye) were recorded.

  • Number of Participants With Glycaemic Failure Events [ Time Frame: Baseline through to end of randomised dual therapy ] [ Designated as safety issue: No ]
    Failure of glycaemic control was defined as two consecutive HbA1c values of ≥8.5 percent, or HbA1c ≥8.5percent at a single visit, after which the subject was either moved to the post-randomised treatment phase or triple therapy was started.

  • Number of Participants With Addition of Third Oral Agent/Switch to Insulin [ Time Frame: Baseline through End of Study (up to 7.5 years) ] [ Designated as safety issue: No ]
    The number of participants with addition of a third oral agent or switch to insulin from randomised dual combination treatment were recorded.

  • The Number of Participants Starting Insulin at Any Time During the Study [ Time Frame: Baseline through End of Study (up to 7.5 years) ] [ Designated as safety issue: No ]
    The number of participants starting insulin at any time during the study was recorded.

  • Model Adjusted Change From Baseline in HbA1c at Month 60 [ Time Frame: Baseline and Month 60 of randomised dual therapy treatment period ] [ Designated as safety issue: No ]
    Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in HbA1c was calculated as the value at Month 60 minus the Baseline value.

  • Model Adjusted Change From Baseline in Fasting Plasma Glucose at Month 60 [ Time Frame: Baseline to Month 60 of the randomised dual therapy treatment period ] [ Designated as safety issue: No ]
    Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in fasting plasma glucose was calculated as the value at Month 60 minus the Baseline value.

  • Model Adjusted Mean Change From Baseline in Insulin and Pro-insulin at Month 60 [ Time Frame: Baseline to Month 60 of the randomised dual therapy treatment period ] [ Designated as safety issue: No ]
    Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in insulin and pro-insulin was calculated as the value at Month 60 minus the Baseline value.

  • Number of HbA1c and Fasting Plasma Glucose (FPG) Responders at Month 60 [ Time Frame: Baseline to Month 60 of the randomised dual therapy treatment period ] [ Designated as safety issue: No ]
    Number of responders, i.e., participants meeting glycaemic targets (HbA1c less than or equal to 7 percent, FPG less than or equal to 7 mmol/L)

  • Model Adjusted Ratio to Baseline (Expressed as a Percentage) Homeostasis Model Assessment (HOMA) Beta Cell Function and Insulin Sensitivity at Month 60 [ Time Frame: Baseline to Month 60 of the randomised dual therapy treatment phase ] [ Designated as safety issue: No ]
    The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in HOMA beta-cell function and insulin sensitivity was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).

  • 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 [ Time Frame: Baseline to Month 60 of the randomised dual therapy treatment phase ] [ Designated as safety issue: No ]
    The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in TC, LDL cholesterol, HDL cholesterol, triglycerides, and FFAs was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).

  • 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 [ Time Frame: Baseline to Month 60 of the randomised dual therapy treatment period ] [ Designated as safety issue: No ]
    The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in TC:HDL cholesterol and LDL cholesterol:HDL cholesterol was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).

  • Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Apolipoprotein B (Apo-B) at Month 60 [ Time Frame: Baseline to Month 60 of the randomised dual therapy treatment period ] [ Designated as safety issue: No ]
    The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in Apo-B was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).

  • Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Urinary Albumin Creatinine Ratio at Month 60 [ Time Frame: Baseline to Month 60 of the randomised dual therapy treatment phase ] [ Designated as safety issue: No ]
    The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in urinary albumin creatinine ratio was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).

  • Model Adjusted Change From Baseline in Body Weight at Month 60 [ Time Frame: Baseline to Month 60 of the randomised dual therapy treatment phase ] [ Designated as safety issue: No ]
    Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in body weight was calculated as the value at Month 60 minus the Baseline value.

  • Model Adjusted Change From Baseline in Alanine Aminotransferase at Month 60 [ Time Frame: Baseline to Month 60 of the randomised dual therapy treatment phase ] [ Designated as safety issue: No ]
    Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in alanine aminotransferase was calculated as the value at Month 60 minus the Baseline value.

  • Model Adjusted Change From Baseline in Waist Circumference at Month 60 [ Time Frame: Baseline to Month 60 of the randomised dual therapy treatment phase ] [ Designated as safety issue: No ]
    Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in waist circumference was calculated as the value at Month 60 minus the Baseline value.

  • Model Adjusted Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Month 60 [ Time Frame: Baseline to Month 60 of the randomised dual therapy treatment phase ] [ Designated as safety issue: No ]
    Model adjusted (adjusted for any imbalances in the baseline values between within treatment groups) change from baseline in SBP and DBP was calculated as the value at Month 60 minus the Baseline value.

  • Model Adjusted Ratio to Baseline (Expressed as a Percentage) for C-Reactive Protein at Month 60 [ Time Frame: Baseline to Month 60 of the randomised dual therapy treatment phase ] [ Designated as safety issue: No ]
    The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in C-Reactive Protein was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).

  • Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Fibrinogen at Month 60 [ Time Frame: Baseline to Month 60 of the randomised dual therapy treatment phase ] [ Designated as safety issue: No ]
    The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in fibrinogen was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).

  • Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Plasminogen Activator Inhibitor-1 (PAI-1) Antigen at Month 60 [ Time Frame: Baseline to Month 60 of the randomised dual therapy treatment phase ] [ Designated as safety issue: No ]
    The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in plasminogen activator inhibitor-1 (PAI-1) antigen was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).

  • 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 [ Time Frame: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years) ] [ Designated as safety issue: No ]
    The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.

  • Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Observational Follow-up [ Time Frame: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years) ] [ Designated as safety issue: No ]
    The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.

  • 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 [ Time Frame: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years) ] [ Designated as safety issue: No ]
    The observational follow-up (OFU) was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. The neoplasms/cancer events of bladder, breast, colon, liver, pancreatic, prostate cancer, and melanoma were pre-specified as cancers of interest for the OFU. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.

  • 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 [ Time Frame: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years) ] [ Designated as safety issue: No ]
    The observational follow-up (OFU) was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. The neoplasms/cancer events of bladder, breast, colon, liver, pancreatic, prostate cancer, and melanoma were pre-specified as cancers of interest for the OFU. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.

  • Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined [ Time Frame: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years) ] [ Designated as safety issue: No ]
    The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.

  • Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up [ Time Frame: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years) ] [ Designated as safety issue: No ]
    The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.

  • Number of Participants With a Bone Fracture Event - Overall and by Gender: Main Study and Observational Follow-up Combined [ Time Frame: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years) ] [ Designated as safety issue: No ]
    The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.

  • Number of Participants With a Bone Fracture Event - Overall and by Gender: Observational Follow-up [ Time Frame: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years) ] [ Designated as safety issue: No ]
    The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.

  • 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 [ Time Frame: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years) ] [ Designated as safety issue: No ]
    The OFU was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.

  • 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 [ Time Frame: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years) ] [ Designated as safety issue: No ]
    The OFU was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.

  • Number of Participants With an Event of Death Due to a Bone Fracture-related Event: Main Study + Observational Follow-up Combined [ Time Frame: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years) ] [ Designated as safety issue: No ]
    The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.

  • Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined [ Time Frame: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years) ] [ Designated as safety issue: No ]
    The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date that had the same Higher Level Group Term (HLGT) for fracture location, per participant.

  • Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up [ Time Frame: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years) ] [ Designated as safety issue: No ]
    The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date that had the same Higher Level Group Term (HLGT) for fracture location, per participant.

  • Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined [ Time Frame: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years) ] [ Designated as safety issue: No ]
    The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The following bone fractures were grouped and were identified as potentially high morbidity bone fractures: hip, pelvis, upper leg, vertebral (lumbar spine, thoracic spine, cervical spine, spine - site unknown).

  • 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 [ Time Frame: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years) ] [ Designated as safety issue: No ]
    The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The following bone fractures were grouped and were identified as potentially high morbidity bone fractures: hip, pelvis, upper leg, vertebral (lumbar spine, thoracic spine, cervical spine, spine - site unknown).

  • Number of Participants With Bone Fracture Events of the Indicated Cause: Main Study + Observational Follow-up Combined [ Time Frame: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years) ] [ Designated as safety issue: No ]
    The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.

  • Number of Participants With Bone Fracture Events of the Indicated Cause: Observational Follow-up [ Time Frame: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years) ] [ Designated as safety issue: No ]
    The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included "Unknown" as a category. Fracture events with missing outcome data were reported as "Data unavailable."

  • Number of Bone Fracture Events With the Indicated Outcome: Main Study + Observational Follow-up Combined [ Time Frame: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years) ] [ Designated as safety issue: No ]
    The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included "Unknown" as a category. Fracture events with missing outcome data were reported as "Data unavailable."

  • Number of Bone Fracture Events With the Indicated Outcome: Observational Follow-up [ Time Frame: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years) ] [ Designated as safety issue: No ]
    The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included "Unknown" as a category. Fracture events with missing outcome data were reported as "Data unavailable."

  • Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up [ Time Frame: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years) ] [ Designated as safety issue: No ]
    The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.


Enrollment: 4447
Study Start Date: April 2001
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rosiglitazone in addition to background metformin
Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Drug: Rosiglitazone
Rosiglitazone maximum 8 mg per day
Drug: Metformin
Metformin maximum permitted daily dose .
Experimental: rosiglitazone in addition to background sulfonylurea
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Drug: Rosiglitazone
Rosiglitazone maximum 8 mg per day
Drug: Sulfonylurea
Sulfonylurea (SU) maximum permitted daily dose
Active Comparator: Sulfonylurea in addition to background metformin
Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or miconizied equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Drug: Sulfonylurea
Sulfonylurea (SU) maximum permitted daily dose
Drug: Metformin
Metformin maximum permitted daily dose .
Active Comparator: Metformin in addition to background sulfonylurea
Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
Drug: Sulfonylurea
Sulfonylurea (SU) maximum permitted daily dose
Drug: Metformin
Metformin maximum permitted daily dose .

Detailed Description:

A RECORD follow-up study is being performed to monitor the incidence of cancer and bone fractures in RECORD patients for a period of 4 years after the end of the main RECORD study (2008 - 2012).

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379769

  Hide Study Locations
Locations
Australia, New South Wales
GSK Investigational Site
Miranda, New South Wales, Australia, 2228
GSK Investigational Site
Randwick, New South Wales, Australia, 2031
GSK Investigational Site
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
GSK Investigational Site
Carina Heights, Queensland, Australia, 4152
GSK Investigational Site
Kippa Ring, Queensland, Australia, 4021
GSK Investigational Site
Sherwood, Queensland, Australia, 4075
Australia, South Australia
GSK Investigational Site
Keswick, South Australia, Australia, 5035
GSK Investigational Site
North Adelaide, South Australia, Australia, 5006
GSK Investigational Site
Port Lincoln, South Australia, Australia, 5606
Australia, Victoria
GSK Investigational Site
Heidelberg, Victoria, Australia, 3084
GSK Investigational Site
Malvern, Victoria, Australia, 3144
Belgium
GSK Investigational Site
Antwerpen, Belgium, 2000
GSK Investigational Site
Arlon, Belgium, 6700
GSK Investigational Site
Brussels, Belgium, 1090
GSK Investigational Site
Edegem, Belgium, 2650
GSK Investigational Site
Genk, Belgium, 3600
GSK Investigational Site
Gent, Belgium, 9000
GSK Investigational Site
Kortrijk, Belgium, 8500
GSK Investigational Site
Liege, Belgium, 4000
GSK Investigational Site
Moerkerke, Belgium, 8340
GSK Investigational Site
Oostham, Belgium, 3945
GSK Investigational Site
Roeselare, Belgium, 8800
GSK Investigational Site
Sint Gillis-Waas, Belgium, 9170
GSK Investigational Site
Vilvoorde, Belgium, 1800
Bulgaria
GSK Investigational Site
Pleven, Bulgaria, 5800
GSK Investigational Site
Plovdiv, Bulgaria, 4002
GSK Investigational Site
Sofia, Bulgaria, 1606
GSK Investigational Site
Sofia, Bulgaria, 1301
GSK Investigational Site
Sofia, Bulgaria, 1431/1000
GSK Investigational Site
Sofia, Bulgaria, 1303
GSK Investigational Site
Sofia, Bulgaria, 1233
GSK Investigational Site
Varna, Bulgaria, 9010
Croatia
GSK Investigational Site
Krapinske Toplice, Croatia, 49217
GSK Investigational Site
Rijeka, Croatia, 51000
GSK Investigational Site
Slavonski Brod, Croatia, 35000
GSK Investigational Site
Varaždin, Croatia, 42000
GSK Investigational Site
Zagreb, Croatia, 10000
Czech Republic
GSK Investigational Site
Brno, Czech Republic, 625 00
GSK Investigational Site
Ceske Budejovice, Czech Republic, 370 87
GSK Investigational Site
Holice V Cechach, Czech Republic, 534 01
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 05
GSK Investigational Site
Jindrichuv Hradec, Czech Republic, 377 38
GSK Investigational Site
Ostrava Poruba, Czech Republic, 708 52
GSK Investigational Site
Pisek, Czech Republic, 397 01
GSK Investigational Site
Praha 2, Czech Republic, 128 42
GSK Investigational Site
Praha 4, Czech Republic, 140 21
GSK Investigational Site
Rakovnik, Czech Republic, 269 01
GSK Investigational Site
Tabor, Czech Republic, 390 00
GSK Investigational Site
Trutnov, Czech Republic, 541 21
Denmark
GSK Investigational Site
Aalborg, Denmark, DK-9100
GSK Investigational Site
Aarhus, Denmark
GSK Investigational Site
Copenhagen, Denmark, 2300
GSK Investigational Site
Glostrup, Denmark
GSK Investigational Site
Hilleroed, Denmark, 3400
GSK Investigational Site
Koge, Denmark, 4600
GSK Investigational Site
Kolding, Denmark, DK-6000
GSK Investigational Site
København NV, Denmark
GSK Investigational Site
Naestved, Denmark, 4700
GSK Investigational Site
Odense C, Denmark, DK-5000
GSK Investigational Site
Silkeborg, Denmark, 8600
GSK Investigational Site
Slagelse, Denmark, 4200
Estonia
GSK Investigational Site
Paide, Estonia, 72714
GSK Investigational Site
Parnu, Estonia, 80018
GSK Investigational Site
Rakvere, Estonia, 44316
GSK Investigational Site
Saku, Estonia, 75501
GSK Investigational Site
Tallinn, Estonia, 13415
GSK Investigational Site
Tallinn, Estonia, 1162
GSK Investigational Site
Tallinn, Estonia, 10138
GSK Investigational Site
Tallinn, Estonia, 11911
GSK Investigational Site
Tartu, Estonia
GSK Investigational Site
Viljandi, Estonia, 71024
Finland
GSK Investigational Site
Espoo, Finland, 02710
GSK Investigational Site
Espoo, Finland, 02600
GSK Investigational Site
Hanko, Finland, 10900
GSK Investigational Site
Helsinki, Finland, 00930
GSK Investigational Site
Helsinki, Finland, 00810
GSK Investigational Site
Helsinki, Finland, 00150
GSK Investigational Site
Hyvinkaa, Finland, 05800
GSK Investigational Site
Jyväskylä, Finland, 40100
GSK Investigational Site
Kerava, Finland, 04200
GSK Investigational Site
Kuopio, Finland, 70210
GSK Investigational Site
Lahti, Finland, 15850
GSK Investigational Site
Lappeenranta, Finland, 53100
GSK Investigational Site
Oulun kaupunki, Finland, 90015
GSK Investigational Site
Riihimäki, Finland, 11130
GSK Investigational Site
Rovaniemi, Finland
GSK Investigational Site
Seinajoki, Finland, 60220
GSK Investigational Site
Tampere, Finland, 33100
GSK Investigational Site
Turku, Finland, 20100
GSK Investigational Site
Turku, Finland, 20700
France
GSK Investigational Site
Bully Les Mines, Nord-Pas-de-Calais, France, 62160
GSK Investigational Site
Amilly, France, 28300
GSK Investigational Site
Arras, France, 62000
GSK Investigational Site
Aspach le Bas 68700, France, 68700
GSK Investigational Site
Aubagne, France, 13400
GSK Investigational Site
Auchy les Hesdin, France, 62770
GSK Investigational Site
Azille, France, 11700
GSK Investigational Site
Beaumont Le Roger, France, 21170
GSK Investigational Site
Beaumont sur Leze, France, 31870
GSK Investigational Site
Belfort, France, 90000
GSK Investigational Site
Belpech, France, 11420
GSK Investigational Site
Blotzheim, France
GSK Investigational Site
Bondy, France, 93143
GSK Investigational Site
BP 1542 Dijon, France, 21034
GSK Investigational Site
Broglie, France, 27270
GSK Investigational Site
Calmont, France, 31560
GSK Investigational Site
Carbonne, France, 31390
GSK Investigational Site
Carcassonne, France, 11000
GSK Investigational Site
Carcassonne, France
GSK Investigational Site
Carcassonne 11000, France, 11000
GSK Investigational Site
Cassis, France, 13260
GSK Investigational Site
Castelnaudary, France, 11400
GSK Investigational Site
Catelnaudary, France, 11400
GSK Investigational Site
Cernay, France, 68700
GSK Investigational Site
Champhol, France, 28300
GSK Investigational Site
Chartres, France, 28000
GSK Investigational Site
Colmar, France, 68000
GSK Investigational Site
Corbeil Essonne, France, 91014
GSK Investigational Site
Coursan, France, 11110
GSK Investigational Site
Cuincy, France, 59553
GSK Investigational Site
Danjoutin, France, 90400
GSK Investigational Site
Dessenheim, France, 68600
GSK Investigational Site
Dieppe, France, 76200
GSK Investigational Site
Dunkerque, France, 59385
GSK Investigational Site
Epernon, France, 28230
GSK Investigational Site
Gemenos, France, 13420
GSK Investigational Site
Hanches, France, 28130
GSK Investigational Site
Hautot sur Mer, France, 76550
GSK Investigational Site
Husseren Wesserling, France, 68470
GSK Investigational Site
Kembs, France, 68680
GSK Investigational Site
La Barre En Ouche, France, 27330
GSK Investigational Site
La Verdière, France, 83560
GSK Investigational Site
Labarth-Sur-Leze, France, 31860
GSK Investigational Site
Labarthe-Sur-Leze, France, 31860
GSK Investigational Site
Le Grau Du Roi, France, 30240
GSK Investigational Site
Le Lherm 31600, France, 31600
GSK Investigational Site
Le Perray En Yvelines, France, 78610
GSK Investigational Site
Lezignan-Corbières, France, 11200
GSK Investigational Site
Maintenon, France, 28130
GSK Investigational Site
Marseille, France, 13003
GSK Investigational Site
Marseille, France, 13008
GSK Investigational Site
Marseille, France, 13016
GSK Investigational Site
Marseille, France, 13014
GSK Investigational Site
Marseille, France, 13011
GSK Investigational Site
Marseille, France, 13001
GSK Investigational Site
Marseille, France, 13013
GSK Investigational Site
Masevaux, France, 68290
GSK Investigational Site
Maubeuge, France, 59600
GSK Investigational Site
Monfort sur Risle, France, 27290
GSK Investigational Site
Mulhouse, France, 68100
GSK Investigational Site
Muret, France, 31600
GSK Investigational Site
Nassandres, France, 27550
GSK Investigational Site
Nevers cedex, France, 58033
GSK Investigational Site
Nogent le Phaye, France, 28630
GSK Investigational Site
Orbec, France, 14290
GSK Investigational Site
Paris, France, 75730
GSK Investigational Site
Pierre Benite Cedex, France, 69495
GSK Investigational Site
Pierres, France, 28130
GSK Investigational Site
Pinsaguel, France, 31120
GSK Investigational Site
Roux Mesnil Bouteille, France, 76370
GSK Investigational Site
Rugles, France, 27250
GSK Investigational Site
Saint Leger sur Yvelines, France, 78610
GSK Investigational Site
Saint-Eulalie Badens, France, 11800
GSK Investigational Site
Seysses, France, 31600
GSK Investigational Site
Thann, France, 68800
GSK Investigational Site
Thiberville, France, 27230
GSK Investigational Site
Toulouse, France, 31400
GSK Investigational Site
Toulouse, France, 31000
GSK Investigational Site
Toulouse, France, 31500
GSK Investigational Site
Trebbes, France, 01800
GSK Investigational Site
Trebes, France, 11800
GSK Investigational Site
Valenciennes, France, 59322
GSK Investigational Site
Vogelsheim, France, 68600
GSK Investigational Site
Voves, France, 28150
GSK Investigational Site
Wittenheim, France, 68270
Germany
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69120
GSK Investigational Site
Sinsheim, Baden-Wuerttemberg, Germany, 74889
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70197
GSK Investigational Site
Kronach, Bayern, Germany, 96317
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
GSK Investigational Site
Kronberg, Hessen, Germany, 61476
GSK Investigational Site
Ober-Moerlen, Hessen, Germany, 61239
GSK Investigational Site
Offenbach, Hessen, Germany, 63071
GSK Investigational Site
Wetzlar, Hessen, Germany, 35578
GSK Investigational Site
Bad Lauterberg, Niedersachsen, Germany, 37431
GSK Investigational Site
Beckum, Nordrhein-Westfalen, Germany, 59269
GSK Investigational Site
Menden, Nordrhein-Westfalen, Germany, 58706
GSK Investigational Site
Gau-Algesheim, Rheinland-Pfalz, Germany, 55435
GSK Investigational Site
Kallstadt, Rheinland-Pfalz, Germany, 67169
GSK Investigational Site
Lambrecht, Rheinland-Pfalz, Germany, 67466
GSK Investigational Site
Rhaunen, Rheinland-Pfalz, Germany, 55624
GSK Investigational Site
Speyer, Rheinland-Pfalz, Germany, 67346
GSK Investigational Site
Friedrichsthal, Saarland, Germany, 66299
GSK Investigational Site
Burgstaedt, Sachsen, Germany, 09217
GSK Investigational Site
Chemnitz, Sachsen, Germany, 09130
GSK Investigational Site
Dresden, Sachsen, Germany, 01307
GSK Investigational Site
Leipzig, Sachsen, Germany, 04103
GSK Investigational Site
Suhl, Thueringen, Germany, 98529
GSK Investigational Site
Hamburg, Germany, 20249
Greece
GSK Investigational Site
Athens, Greece, 18537
GSK Investigational Site
Athens, Greece, 11527
GSK Investigational Site
Athens, Greece, 115 27
GSK Investigational Site
Athens, Greece, 11521
GSK Investigational Site
Haidari, Athens, Greece, 12462
GSK Investigational Site
Ioannina, Greece, 45001
GSK Investigational Site
Maroussi, Greece, 15123
GSK Investigational Site
Patra, Greece, 26335
GSK Investigational Site
Patra, Greece, 26500
GSK Investigational Site
Piraeus-Athens, Greece, 18536
GSK Investigational Site
Piraeus-Athens, Greece, 18454
GSK Investigational Site
Thessaloniki, Greece, 564 29
GSK Investigational Site
Thessalonikis, Greece, 57010
Hungary
GSK Investigational Site
Budapest, Hungary, 1125
GSK Investigational Site
Budapest, Hungary, 1145
GSK Investigational Site
Budapest, Hungary, 1115
GSK Investigational Site
Budapest, Hungary, 1097
GSK Investigational Site
Budapest, Hungary, 1096
GSK Investigational Site
Budapest, Hungary, 1062
GSK Investigational Site
Budapest, Hungary, 1083
GSK Investigational Site
Debrecen, Hungary, 4043
GSK Investigational Site
Eger, Hungary
GSK Investigational Site
Gyor, Hungary, 9024
GSK Investigational Site
Gyula, Hungary, 5701
GSK Investigational Site
Kurtag99, Hungary
GSK Investigational Site
Nyiregyháza, Hungary, 4400
GSK Investigational Site
Patkaj98, Hungary
GSK Investigational Site
Siofok, Hungary, 8601
GSK Investigational Site
Szentes, Hungary, 6600
GSK Investigational Site
Szombathely, Hungary, 9700
GSK Investigational Site
Veszprem, Hungary, 8200
GSK Investigational Site
Zalaegerszeg, Hungary, 8900
Italy
GSK Investigational Site
Reggio Calabria, Calabria, Italy, 89100
GSK Investigational Site
Napoli, Campania, Italy, 80136
GSK Investigational Site
Nocera Inferiore (SA), Campania, Italy, 84014
GSK Investigational Site
Salerno, Campania, Italy, 84100
GSK Investigational Site
Bologna, Emilia-Romagna, Italy, 40138
GSK Investigational Site
Rimini, Emilia-Romagna, Italy, 47900
GSK Investigational Site
Roma, Lazio, Italy, 00168
GSK Investigational Site
Roma, Lazio, Italy, 00155
GSK Investigational Site
Genova, Liguria, Italy, 16132
GSK Investigational Site
Brescia, Lombardia, Italy, 25123
GSK Investigational Site
Milano, Lombardia, Italy, 20162
GSK Investigational Site
San Donato (MI), Lombardia, Italy, 20097
GSK Investigational Site
Treviglio (BG), Lombardia, Italy, 13115
GSK Investigational Site
Campobasso, Molise, Italy, 86100
GSK Investigational Site
Torino, Piemonte, Italy, 10122
GSK Investigational Site
Cagliari, Sardegna, Italy, 09127
GSK Investigational Site
Sassari, Sardegna, Italy, 07100
GSK Investigational Site
Palermo, Sicilia, Italy, 90127
GSK Investigational Site
Pisa, Toscana, Italy, 56126
GSK Investigational Site
Bari, Italy, 70124
GSK Investigational Site
Parma, Italy, 43100
GSK Investigational Site
Roma, Italy, 00168
Latvia
GSK Investigational Site
Jekabpils, Latvia, LV 5201
GSK Investigational Site
Lagzdi60, Latvia
GSK Investigational Site
Limbazi, Latvia, LV 4001
GSK Investigational Site
Ogre, Latvia, LV 5001
GSK Investigational Site
Riga, Latvia, LV 1057
GSK Investigational Site
Riga, Latvia, LV 1011
GSK Investigational Site
Riga, Latvia, 1006
GSK Investigational Site
Riga, Latvia, LV1002
GSK Investigational Site
Sturii59, Latvia
GSK Investigational Site
Tukums, Latvia, LV 3100
Lithuania
GSK Investigational Site
Kaunas, Lithuania, LT-49476
GSK Investigational Site
Kaunas, Lithuania, LT-47144
GSK Investigational Site
Kaunas, Lithuania, LT-51270
GSK Investigational Site
Kaunas, Lithuania, LT-50009
GSK Investigational Site
Klaipeda, Lithuania, 92304
GSK Investigational Site
Vilnius, Lithuania, LT-04318
GSK Investigational Site
Vilnius, Lithuania, LT-10103
GSK Investigational Site
Vilnius, Lithuania, LT 08661
Netherlands
GSK Investigational Site
Geleen, Netherlands, 6160 BB
GSK Investigational Site
Groningen, Netherlands, 9711 SG
GSK Investigational Site
Hengelo, Netherlands, 7555 DL
GSK Investigational Site
Hoogvliet, Netherlands, 3192 JN
GSK Investigational Site
Kerkrade, Netherlands, 6461 XP
GSK Investigational Site
Landgraaf, Netherlands, 6373 JS
GSK Investigational Site
Musselkanaal, Netherlands, 9581 AD
GSK Investigational Site
Nijmegen, Netherlands, 6525 EC
GSK Investigational Site
Oude Pekela, Netherlands, 9665 AR
GSK Investigational Site
Ridderkerk, Netherlands, 2985 BV
GSK Investigational Site
Rijswijk, Netherlands, 2281 AK
GSK Investigational Site
Roosendaal, Netherlands, 4701 LJ
GSK Investigational Site
Rotterdam, Netherlands, 3082 KC
GSK Investigational Site
Rotterdam, Netherlands, 3021 HC
GSK Investigational Site
St. Willebrord, Netherlands, 4711 EG
GSK Investigational Site
Zoetermeer, Netherlands, 2724 EK
GSK Investigational Site
Zwijndrecht, Netherlands, 3334 XA
GSK Investigational Site
Zwijndrecht, Netherlands, 3331 AE
New Zealand
GSK Investigational Site
Christchurch, New Zealand, 8011
GSK Investigational Site
Dunedin, New Zealand, 9016
GSK Investigational Site
Hastings, New Zealand, Private Bag 9014
GSK Investigational Site
Otahuhu, Auckland, New Zealand, 2025
GSK Investigational Site
Palmerston North, New Zealand, 4410
GSK Investigational Site
Takapuna, Auckland, New Zealand, 0620
GSK Investigational Site
Tauranga, New Zealand, 3112
GSK Investigational Site
Wellington, New Zealand, 6002
Poland
GSK Investigational Site
Bialystok, Poland, 15-276
GSK Investigational Site
Bydgoszcz, Poland, 85 822
GSK Investigational Site
Gdansk, Poland, 80 211
GSK Investigational Site
Grudziadz, Poland, 86-300
GSK Investigational Site
Krakow, Poland, 31 501
GSK Investigational Site
Krakow, Poland, 31 261
GSK Investigational Site
Lodz, Poland, 90 030
GSK Investigational Site
Lublin, Poland, 20-718
GSK Investigational Site
Lublin, Poland, 02 081
GSK Investigational Site
Olsztyn, Poland, 10 461
GSK Investigational Site
Poznan, Poland, 61 696
GSK Investigational Site
Poznan, Poland, 60-834
GSK Investigational Site
Warszawa, Poland, 02 507
GSK Investigational Site
Warszawa, Poland, 01-337
GSK Investigational Site
Warszawa, Poland, 01 887
GSK Investigational Site
Warszawa, Poland, 02-042
GSK Investigational Site
Wroclaw, Poland, 50-127
Romania
GSK Investigational Site
Bucharest, Romania, 020475
GSK Investigational Site
Bucuresti, Romania, 011234
GSK Investigational Site
Bucuresti, Romania, 022448
GSK Investigational Site
Cluj-Napoca, Romania, 400006
GSK Investigational Site
Craiova, Romania, 2000642
GSK Investigational Site
Iasi, Romania, 700111
GSK Investigational Site
Timisoara, Romania, 293406
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 129110
GSK Investigational Site
Moscow, Russian Federation, 115 280
GSK Investigational Site
Moscow, Russian Federation, 117049
GSK Investigational Site
Moscow, Russian Federation, 125367
GSK Investigational Site
St Petersburg, Russian Federation, 195257
GSK Investigational Site
St-Petersburg, Russian Federation, 194291
Slovakia
GSK Investigational Site
Banska Bystrica, Slovakia, 975 17
GSK Investigational Site
Bratislava, Slovakia, 82108
GSK Investigational Site
Bratislava, Slovakia, 811 08
GSK Investigational Site
Bratislava, Slovakia, 813 69
GSK Investigational Site
Bratislava, Slovakia, 82102
GSK Investigational Site
Kosice, Slovakia, 040 11
GSK Investigational Site
Kosice, Slovakia, 041 90
GSK Investigational Site
Kysucke Nove Mesto, Slovakia, 024 01
GSK Investigational Site
Lubochna, Slovakia, 034 91
GSK Investigational Site
Lucenec, Slovakia, 984 01
GSK Investigational Site
Presov, Slovakia, 08001
GSK Investigational Site
Prievidza, Slovakia, 97201
GSK Investigational Site
Sahy, Slovakia, 936 01
GSK Investigational Site
Samorin, Slovakia, 931 01
GSK Investigational Site
Trencin, Slovakia, 911 01
GSK Investigational Site
Zilina, Slovakia, 010 01
Spain
GSK Investigational Site
Badalona, Spain, 08911
GSK Investigational Site
Barcelona, Spain, 08036
GSK Investigational Site
Barcelona, Spain, 08025
GSK Investigational Site
Benidorm, Spain, 03500
GSK Investigational Site
Bilbao, Spain, 48903
GSK Investigational Site
Caceres, Spain, 10003
GSK Investigational Site
Cadiz, Spain, 11009
GSK Investigational Site
Granada, Spain, 18012
GSK Investigational Site
Madrid, Spain, 28034
GSK Investigational Site
Madrid, Spain, 28040
GSK Investigational Site
Palma de Mallorca, Spain, 7014
GSK Investigational Site
Reus, Spain, 43201
GSK Investigational Site
Santander, Spain, 38008
GSK Investigational Site
Vazquc56, Spain
GSK Investigational Site
Vizcaya, Spain, 48910
GSK Investigational Site
Vizcaya, Spain, 48920
Sweden
GSK Investigational Site
Eksjö, Sweden, SE-575 81
GSK Investigational Site
Göteborg, Sweden, SE-413 45
GSK Investigational Site
Göteborg, Sweden, SE-416 65
GSK Investigational Site
Göteborg, Sweden, SE-417 17
GSK Investigational Site
Helsingborg, Sweden, SE-254 37
GSK Investigational Site
Kristianstad, Sweden, SE-291 85
GSK Investigational Site
Kungälv, Sweden, SE-442 83
GSK Investigational Site
Köping, Sweden, SE-73181
GSK Investigational Site
Linköpiing, Sweden, SE-582 25
GSK Investigational Site
Linköping, Sweden, SE-582 46
GSK Investigational Site
Lund, Sweden, SE-221 85
GSK Investigational Site
Mora, Sweden, SE-792 85
GSK Investigational Site
Nacka, Sweden, SE-131 83
GSK Investigational Site
Norrköping, Sweden, SE-602 20
GSK Investigational Site
Oskarshamn, Sweden, SE-572 28
GSK Investigational Site
Skene, Sweden, SE-511 62
GSK Investigational Site
Stockholm, Sweden, SE-182 88
GSK Investigational Site
Uddevalla, Sweden, SE-451 40
GSK Investigational Site
Umeå, Sweden, SE-901 85
GSK Investigational Site
Uppsala, Sweden, SE-751 25
GSK Investigational Site
Vadstena, Sweden, SE-592 32
Ukraine
GSK Investigational Site
Dnepropetrovsk, Ukraine, 49044
GSK Investigational Site
Kharkiv, Ukraine, 61002
GSK Investigational Site
Kiev, Ukraine, 02175
GSK Investigational Site
Kiev, Ukraine, 04114
GSK Investigational Site
Kyiv, Ukraine, 01004
GSK Investigational Site
Lvov, Ukraine, 79010
GSK Investigational Site
Vinnitsa, Ukraine, 21010
United Kingdom
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
GSK Investigational Site
Fowley, Cornwall, United Kingdom, PL23 1DT
GSK Investigational Site
Chesterfield, Derbyshire, United Kingdom, S44 6DE
GSK Investigational Site
Chesterfield, Derbyshire, United Kingdom, S40 4TF
GSK Investigational Site
Airdrie, Lanarkshire, United Kingdom, ML6 0JS
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G51 4TF
GSK Investigational Site
Hamilton, Lanarkshire, United Kingdom, ML3 0DR
GSK Investigational Site
Motherwell, Lanarkshire, United Kingdom, ML1 3JX
GSK Investigational Site
Leicester, Leicestershire, United Kingdom, LE1 5WW
GSK Investigational Site
Northampton, Northamptonshire, United Kingdom, NN5 7AQ
GSK Investigational Site
Northampton, Northamptonshire, United Kingdom, NN1 5BD
GSK Investigational Site
Linwood, Renfrewshire, United Kingdom
GSK Investigational Site
Paisley, Renfrewshire, United Kingdom, PA1 1UB
GSK Investigational Site
Frome, Somerset, United Kingdom, BA11 1EZ
GSK Investigational Site
Glastonbury, Somerset, United Kingdom, BA6 9LP
GSK Investigational Site
Rugby, Warwickshire, United Kingdom, CV21 3SP
GSK Investigational Site
Rugby, Warwickshire, United Kingdom, CV22 5PX
GSK Investigational Site
Corsham, Wiltshire, United Kingdom, SN13 9DL
GSK Investigational Site
Trowbridge, Wiltshire, United Kingdom, BA14 8QA
GSK Investigational Site
Trowbridge, Wiltshire, United Kingdom, BA14 9AR
GSK Investigational Site
Westbury, Wiltshire, United Kingdom, BA13 3JD
GSK Investigational Site
Airdrie, United Kingdom, ML6 0JH
GSK Investigational Site
Airdrie, United Kingdom, ML6 0JU
GSK Investigational Site
Ashford, United Kingdom, TW15 2TU
GSK Investigational Site
Bath, United Kingdom, BA2 3HT
GSK Investigational Site
Chesterfield, United Kingdom, S40 1LE
GSK Investigational Site
Chippenham, United Kingdom, SN15 2SB
GSK Investigational Site
Coatbridge, United Kingdom, ML5 3AP
GSK Investigational Site
Colney, United Kingdom, NR4 7UY
GSK Investigational Site
Cumbernauld, United Kingdom, G67 3BE
GSK Investigational Site
Dronfield, United Kingdom, S18 1RU
GSK Investigational Site
Dumbarton, United Kingdom, G82 1PW
GSK Investigational Site
East Kilbride, United Kingdom, G75 8RG
GSK Investigational Site
Falmouth, United Kingdom, TR11 2LH
GSK Investigational Site
Garston, Watford, United Kingdom, WD2 6EB
GSK Investigational Site
Gateshead, United Kingdom, NE9 6SX
GSK Investigational Site
Glasgow, United Kingdom
GSK Investigational Site
Glasgow, United Kingdom, G5 OPQ
GSK Investigational Site
Hamilton, United Kingdom, ML3 8AA
GSK Investigational Site
Harrow, United Kingdom, HA3 7LT
GSK Investigational Site
Kirkintilloch, United Kingdom, G66 1JB
GSK Investigational Site
Leigh on Sea, United Kingdom, SS9 2SQ
GSK Investigational Site
Motherwell, United Kingdom, ML1 2PS
GSK Investigational Site
Newcastle upon Tyne, United Kingdom, NE1 4LP
GSK Investigational Site
Newport, United Kingdom, PO30 5TG
GSK Investigational Site
Nottingham, United Kingdom, NG5 1PB
GSK Investigational Site
Old Whittington, Chesterfield, United Kingdom, S41 9JZ
GSK Investigational Site
Paisley, United Kingdom, PA3 2DY
GSK Investigational Site
Penzance, United Kingdom, TR18 4JH
GSK Investigational Site
Rubery, Birmingham, United Kingdom, B45 9JT
GSK Investigational Site
Sheffield, United Kingdom, S5 7TW
GSK Investigational Site
Sheffield, United Kingdom, S5 7QB
GSK Investigational Site
Thornhill, United Kingdom, DG3 5AA
GSK Investigational Site
Thornhill, Cardiff, United Kingdom, CF14 9BB
GSK Investigational Site
Uddingston, United Kingdom, G71 5SU
GSK Investigational Site
Weston Super Mare, United Kingdom, BS23 4BP
GSK Investigational Site
Wishaw, United Kingdom, ML2 7BQ
GSK Investigational Site
Woking, United Kingdom, GU21 1TD
GSK Investigational Site
Worle, Weston-Super-Mare, United Kingdom, BS22 6AJ
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Home PD, Pocock SJ, Beck-Nielsen H et al. The Lancet 2009; 373:2125-2135.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00379769     History of Changes
Other Study ID Numbers: BRL-049653/231
Study First Received: September 21, 2006
Results First Received: August 24, 2009
Last Updated: December 13, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
diabetes
CV outcomes
rosiglitazone
Type II diabetes
sulfonylurea
RECORD
metformin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rosiglitazone
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 10, 2014