Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
RSG in Addition to Background MET	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.
SU in Addition to Background MET	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 micronized 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.
RSG in Addition to Background SU	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.
MET in Addition to Background SU	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.

Participant Flow:   Overall Study

	RSG in Addition to Background MET	SU in Addition to Background MET	RSG in Addition to Background SU	MET in Addition to Background SU
STARTED	1117	1105	1103	1122
COMPLETED	939	906	896	892
NOT COMPLETED	178	199	207	230
Death	57	67	54	72
Adverse Event	5	8	10	11
Lost to Follow-up	29	29	25	26
Withdrawal by Subject	46	56	72	70
Moved to survival status follow-up only	27	25	32	36
Participant moved	3	2	3	3
Poor compliance	3	2	2	1
Prohibited glucose lowering medication	0	3	0	1
Site closed	4	4	4	8
Entry criteria violation	0	0	1	1
Participant did not take study drug	0	0	1	0
Physician Decision	2	2	1	1
Participant completed study at visit 27	1	0	0	0
Personal reasons	1	0	0	0
Risk of heart failure	0	1	0	0
Investigator refused to log temperature	0	0	1	0
Reason unspecified	0	0	1	0

Reporting Groups

	Description
RSG in Addition to Background MET	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.
SU in Addition to Background MET	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 micronized 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.
RSG in Addition to Background SU	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.
MET in Addition to Background SU	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.

Baseline Measures

	RSG in Addition to Background MET	SU in Addition to Background MET	RSG in Addition to Background SU	MET in Addition to Background SU	Total
Number of Participants   [units: participants]	1117	1105	1103	1122	4447
Age   [units: years] Mean ± Standard Deviation	57.0 ± 8.02	57.2 ± 8.14	59.8 ± 8.26	59.7 ± 8.23	58.4 ± 8.27
Gender   [units: participants]
Female	516	521	562	554	2153
Male	601	584	541	568	2294
Race/Ethnicity, Customized   [units: participants]
White	1105	1087	1095	1112	4399
Black	3	6	2	3	14
Oriental	4	2	5	7	18
Aboriginal	1	0	0	0	1
African	1	0	0	0	1
Asian	1	2	1	0	4
Egyptian	1	0	0	0	1
Gipsy	1	0	0	0	1
Indian	0	1	0	0	1
Maori	0	1	0	0	1
Middle East Hible	0	1	0	0	1
Pacific Islander	0	1	0	0	1
Polynesian	0	1	0	0	1
Sri Lankan	0	2	0	0	2
Tahitian	0	1	0	0	1

1.  Primary:

Number of Participants With Cardiovascular Death/Cardiovascular Hospitalisation Events   [ Baseline through End of Study (up to 7.5 years) ]

2.  Secondary:

Number of Participants With Cardiovascular Events and All-cause Deaths   [ Baseline through End of Study (up to 7.5 years) ]

3.  Secondary:

Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths   [ Baseline through End of Study (up to 7.5 years) ]

4.  Secondary:

Number of Participants With First Cardiovascular Hospitalisations/Cardiovascular Deaths by Stratum   [ Baseline through End of Study (up to 7.5 years) ]

5.  Secondary:

Number of Participants With CV/Microvascular Events   [ Baseline through End of Study (up to 7.5 years) ]

6.  Secondary:

Number of Participants With Glycaemic Failure Events   [ Baseline through to end of randomised dual therapy ]

7.  Secondary:

Number of Participants With Addition of Third Oral Agent/Switch to Insulin   [ Baseline through End of Study (up to 7.5 years) ]

8.  Secondary:

The Number of Participants Starting Insulin at Any Time During the Study   [ Baseline through End of Study (up to 7.5 years) ]

9.  Secondary:

Model Adjusted Change From Baseline in HbA1c at Month 60   [ Baseline and Month 60 of randomised dual therapy treatment period ]

10.  Secondary:

Model Adjusted Change From Baseline in Fasting Plasma Glucose at Month 60   [ Baseline to Month 60 of the randomised dual therapy treatment period ]

11.  Secondary:

Model Adjusted Mean Change From Baseline in Insulin and Pro-insulin at Month 60   [ Baseline to Month 60 of the randomised dual therapy treatment period ]

12.  Secondary:

Number of HbA1c and Fasting Plasma Glucose (FPG) Responders at Month 60   [ Baseline to Month 60 of the randomised dual therapy treatment period ]

13.  Secondary:

Model Adjusted Ratio to Baseline (Expressed as a Percentage) Homeostasis Model Assessment (HOMA) Beta Cell Function and Insulin Sensitivity at Month 60   [ Baseline to Month 60 of the randomised dual therapy treatment phase ]

14.  Secondary:

Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Triglycerides, and Free Fatty Acids at Month 60   [ Baseline to Month 60 of the randomised dual therapy treatment phase ]

15.  Secondary:

Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholersterol:High-density Lipoprotein (HDL) Cholesterol and Low-density Lipoprotein (LDL) Cholesterol:HDL Cholesterol Ratios at Month 60   [ Baseline to Month 60 of the randomised dual therapy treatment period ]

16.  Secondary:

Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Apolipoprotein B (Apo-B) at Month 60   [ Baseline to Month 60 of the randomised dual therapy treatment period ]

17.  Secondary:

Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Urinary Albumin Creatinine Ratio at Month 60   [ Baseline to Month 60 of the randomised dual therapy treatment phase ]

18.  Secondary:

Model Adjusted Change From Baseline in Body Weight at Month 60   [ Baseline to Month 60 of the randomised dual therapy treatment phase ]

19.  Secondary:

Model Adjusted Change From Baseline in Alanine Aminotransferase at Month 60   [ Baseline to Month 60 of the randomised dual therapy treatment phase ]

20.  Secondary:

Model Adjusted Change From Baseline in Waist Circumference at Month 60   [ Baseline to Month 60 of the randomised dual therapy treatment phase ]

21.  Secondary:

Model Adjusted Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Month 60   [ Baseline to Month 60 of the randomised dual therapy treatment phase ]

22.  Secondary:

Model Adjusted Change From Baseline in C- Reactive Protein (CRP) at Month 60   [ Baseline to Month 60 of the randomised dual therapy treatment phase ]

23.  Secondary:

Model Adjusted Change From Baseline in Fibrinogen at Month 60   [ Baseline to Month 60 of the randomised dual therapy treatment phase ]

24.  Secondary:

Model Adjusted Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) Antigen at Month 60   [ Baseline to Month 60 of the randomised dual therapy treatment phase ]