Phase 3 Completed N=4,447 Randomized Treatment

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

Type 2 Diabetes Mellitus

Source: ClinicalTrials.gov NCT00379769 ↗

Enrolled (actual)

4,447

Serious AEs

27.0%

Results posted

Nov 2009

Primary outcomePrimary: Number of Participants With Cardiovascular Death/Cardiovascular Hospitalisation Events — 321; 323 participants

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Cardiovascular Death/Cardiovascular Hospitalisation Events	321; 323	—
PRIMARY Independent Re-adjudication Outcome: Number of Participants Who Died Due to Any Cause	139; 160	—
PRIMARY Independent Re-adjudication (IR) Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Original RECORD Endpoint Definitions	181; 188	—
PRIMARY Independent Re-adjudication Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Contemporary Endpoint Definitions	186; 191	—
PRIMARY Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Original RECORD Endpoint Definitions	88; 96	—
PRIMARY Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Contemporary Endpoint Definitions	88; 96	—
PRIMARY Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions	68; 60	—
PRIMARY Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions	72; 62	—
PRIMARY Independent Re-adjudication Outcome: Number of Participants (Par.) With an Event of Stroke (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions	50; 63	—
PRIMARY Independent Re-adjudication Outcome: Number of Participants With an Event of Stroke (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions	53; 64	—
SECONDARY Number of Participants With Cardiovascular Events and All-cause Deaths	154; 165; 171; 184; 204; 206	—
SECONDARY Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths	60; 71; 7; 10; 10; 2	—
SECONDARY Number of Participants With First Cardiovascular Hospitalisations/Cardiovascular Deaths by Stratum	158; 154; 163; 169	—
SECONDARY Number of Participants With CV/Microvascular Events	363; 385; 59; 78; 42; 52	—
SECONDARY Number of Participants With Glycaemic Failure Events	281; 451; 365; 424	—
SECONDARY Number of Participants With Addition of Third Oral Agent/Switch to Insulin	295; 183; 344; 171; 257; 7	—
SECONDARY The Number of Participants Starting Insulin at Any Time During the Study	126; 276; 168; 259	—
SECONDARY Model Adjusted Change From Baseline in HbA1c at Month 60	-0.14; 0.17; -0.24; -0.10	—
SECONDARY Model Adjusted Change From Baseline in Fasting Plasma Glucose at Month 60	-1.38; -0.29; -2.00; -0.94	—
SECONDARY Model Adjusted Mean Change From Baseline in Insulin and Pro-insulin at Month 60	-18.6; 3.7; -16.9; -12.1; -2.4; 4.2	—
SECONDARY Number of HbA1c and Fasting Plasma Glucose (FPG) Responders at Month 60	265; 208; 235; 180; 300; 180	—
SECONDARY Model Adjusted Ratio to Baseline (Expressed as a Percentage) Homeostasis Model Assessment (HOMA) Beta Cell Function and Insulin Sensitivity at Month 60	20.54; 19.28; 32.35; 12.43; 42.57; -3.45	—
SECONDARY 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	-5.49; -9.09; -2.91; -9.68; 9.95; 2.57	—
SECONDARY 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	-14.20; -11.33; -9.93; -15.01; -20.89; -20.04	—
SECONDARY Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Apolipoprotein B (Apo-B) at Month 60	-13.77; -11.63; -9.68; -12.09	—
SECONDARY Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Urinary Albumin Creatinine Ratio at Month 60	8.31; 15.17; -3.43; 11.91	—
SECONDARY Model Adjusted Change From Baseline in Body Weight at Month 60	3.93; -0.54; 4.72; -2.16	—
SECONDARY Model Adjusted Change From Baseline in Alanine Aminotransferase at Month 60	-37.43; -21.73; -30.17; -24.00	—
SECONDARY Model Adjusted Change From Baseline in Waist Circumference at Month 60	2.70; 0.65; 3.00; -0.60	—
SECONDARY Model Adjusted Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Month 60	-1.9; -2.2; -2.3; -0.6; -3.6; -3.4	—
SECONDARY Model Adjusted Ratio to Baseline (Expressed as a Percentage) for C-Reactive Protein at Month 60	-57.40; -28.92; -56.50; -36.29	—
SECONDARY Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Fibrinogen at Month 60	2.12; 5.74; -0.23; 3.14	—
SECONDARY Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Plasminogen Activator Inhibitor-1 (PAI-1) Antigen at Month 60	-9.85; 15.01; -7.79; -0.64	—
SECONDARY 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	196; 215; 179; 195; 164; 186	—
SECONDARY Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Observational Follow-up	60; 51; 59; 51; 55; 46	—
SECONDARY 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	57; 57; 22; 22; 12; 9	—
SECONDARY 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	18; 8; 7; 1; 5; 2	—
SECONDARY Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined	59; 72; 25; 34; 4; 12	—
SECONDARY Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up	25; 24; 10; 14; 3; 3	—
SECONDARY Number of Participants With a Bone Fracture Event - Overall and by Gender: Main Study and Observational Follow-up Combined	238; 151; 82; 60; 156; 91	—
SECONDARY Number of Participants With a Bone Fracture Event - Overall and by Gender: Observational Follow-up	64; 37; 25; 11; 39; 26	—
SECONDARY 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	81; 57; 41; 17; 24; 16	—
SECONDARY 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	35; 21; 17; 5; 9; 8	—
SECONDARY Number of Participants With an Event of Death Due to a Bone Fracture-related Event: Main Study + Observational Follow-up Combined	0; 0	—
SECONDARY Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined	238; 151; 82; 60; 156; 91	—
SECONDARY Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up	64; 37; 25; 11; 39; 26	—
SECONDARY Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined	31; 31; 10; 13; 21; 18	—
SECONDARY 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	86; 46; 28; 15; 58; 31	—
SECONDARY Number of Participants With Bone Fracture Events of the Indicated Cause: Main Study + Observational Follow-up Combined	238; 151; 113; 55; 110; 77	—
SECONDARY Number of Participants With Bone Fracture Events of the Indicated Cause: Observational Follow-up	64; 37; 36; 14; 24; 17	—
SECONDARY Number of Bone Fracture Events With the Indicated Outcome: Main Study + Observational Follow-up Combined	299; 174; 7; 5; 250; 142	—
SECONDARY Number of Bone Fracture Events With the Indicated Outcome: Observational Follow-up	70; 41; 1; 1; 51; 33	—
SECONDARY Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up	99; 76; 6; 3; 7; 1	—

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00379769). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.