Rosiglitazone Versus a Sulfonylurea On Progression Of Atherosclerosis In Patients With Heart Disease And Type 2 Diabetes

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
Glipizide (GLP) 5 mg	Glipizide (GLP) 5 mg once daily for 18 months
Rosiglitazone (RSG) 4 mg	Rosiglitazone (RSG) 4 mg once daily for 18 months

Participant Flow:   Overall Study

	Glipizide (GLP) 5 mg	Rosiglitazone (RSG) 4 mg
STARTED	337	331
COMPLETED	264	259
NOT COMPLETED	73	72
Adverse Event	14	16
Baseline IVUS determined unevaluable	12	11
Lost to Follow-up	8	6
Protocol Violation	3	6
Hypoglycaemic events	1	0
Low haemoglobin on screening	1	0
Withdrawn investigational product	1	0
Withdrawal by Subject	32	32
Insufficient therapeutic effect	0	1
Missing data for participant	1	0

Reporting Groups

	Description
Glipizide (GLP) 5 mg	Glipizide (GLP) 5 mg once daily for 18 months
Rosiglitazone (RSG) 4 mg	Rosiglitazone (RSG) 4 mg once daily for 18 months
Total	Total of all reporting groups

Baseline Measures

	Glipizide (GLP) 5 mg	Rosiglitazone (RSG) 4 mg	Total
Number of Participants   [units: participants]	337	331	668
Age   [units: years] Mean ± Standard Deviation	60.2  ± 9.05	61.8  ± 8.38	61.0  ± 8.76
Gender   [units: participants]
Female	116	98	214
Male	221	233	454
Race/Ethnicity, Customized   [units: Participants]
White	255	240	495
Oriental	70	82	152
Black	7	4	11
Mixed race	4	2	6
Missing	0	1	1
American Indian/Alaska native	1	2	3
Pre-study Treatment [1] [units: Participants]
Diet and exercise regimen only	64	56	120
Oral anti-diabetic monotherapy	183	182	365
Oral anti-diabetic dual therapy	90	93	183
Smoking history [2] [units: Participants]
Never smoked	152	151	303
Current smoker	57	55	112
Former smoker	128	124	252
Missing	0	1	1
Body Mass Index (BMI) [3] [units: kilograms per square meter (kg/m2)] Median ( Full Range )	29     ( 19 to 52 )	28     ( 17 to 58 )	29     ( 17 to 58 )
Duration of cardiovascular disease [4] [units: Years] Mean ( Full Range )	0.79     ( 0.01 to 28.58 )	0.59     ( 0.00 to 25.19 )	0.73     ( 0.00 to 28 )
Duration of diabetes [5] [units: Years] Median ( Full Range )	4.62     ( 0 to 35.82 )	4.96     ( 0.02 to 31.66 )	4.74     ( 0 to 35.82 )

1.  Primary:

Change From Baseline in Percent Atheroma Volume (PAV) to Month 18   [ Time Frame: Baseline to Month 18 ]

2.  Primary:

Model Adjusted Change From Baseline in Percent Atheroma Volume (PAV) to Month 18   [ Time Frame: Baseline to Month 18 ]

3.  Secondary:

Change From Baseline in Atheroma, Vessel, and Lumen Volume to Month 18   [ Time Frame: Baseline to Month 18 ]

4.  Secondary:

Model Adjusted Change From Baseline in Atheroma Volume to Month 18   [ Time Frame: Baseline to Month 18 ]

5.  Secondary:

Model Adjusted Change From Baseline in Lumen Volume to Month 18   [ Time Frame: Baseline to Month 18 ]

6.  Secondary:

Model Adjusted Change From Baseline in Vessel Volume to Month 18   [ Time Frame: Baseline to Month 18 ]

7.  Secondary:

Change From Baseline in Atheroma, Vessel, and Lumen Area to Month 18   [ Time Frame: Baseline to Month 18 ]

8.  Secondary:

Model Adjusted Change From Baseline in Atheroma Area to Month 18   [ Time Frame: Baseline to Month 18 ]

9.  Secondary:

Model Adjusted Change From Baseline in Lumen Area to Month 18   [ Time Frame: Baseline to Month 18 ]

10.  Secondary:

Model Adjusted Change From Baseline in Vessel Area to Month 18   [ Time Frame: Baseline to Month 18 ]

11.  Secondary:

Change From Baseline in Normalized Atheroma Volume   [ Time Frame: Baseline to Month 18 ]

12.  Secondary:

Model Adjusted Change From Baseline in Normalized Atheroma Volume   [ Time Frame: Baseline to Month 18 ]

13.  Secondary:

Change in Atheroma Volume Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline   [ Time Frame: Baseline to Month 18 ]

14.  Secondary:

Model Adjusted Change in Atheroma Volume Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline   [ Time Frame: Baseline to Month 18 ]

15.  Secondary:

Change in Atheroma Area Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline   [ Time Frame: Baseline to Month 18 ]

16.  Secondary:

Model Adjusted Change in Atheroma Area Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline   [ Time Frame: Baseline to Month 18 ]

17.  Secondary:

Model Adjusted Change in Glycated Hemoglobin (HbA1c) From Baseline to Month 18   [ Time Frame: Baseline to Month 18 ]

18.  Secondary:

Model Adjusted Change in Fasting Plasma Glucose (FPG) From Baseline to Month 18   [ Time Frame: Baseline to Month 18 ]

19.  Secondary:

Repeated Measures Analysis of Percent Change in hsCRP From Baseline to Month 18   [ Time Frame: Baseline to Month 18 ]

20.  Secondary:

Repeated Measures Analysis of Percent Change in MMP 9 From Baseline to Month 18   [ Time Frame: Baseline to Month 18 ]

21.  Secondary:

Percent Change in Brain Natriuretic Peptide (BNP) From Baseline to Month 18   [ Time Frame: Baseline to Month 18 ]

22.  Secondary:

Model Adjusted Percent Change in Brain Natriuretic Peptide (BNP) From Baseline to Month 18   [ Time Frame: Baseline to Month 18 ]

23.  Secondary:

Percent Change From Baseline to Month 18 in Total Cholesterol (TC)   [ Time Frame: Baseline to Month 18 ]

24.  Secondary:

Percent Change From Baseline to Month 18 in High Density Lipoprotein Cholesterol (HDL-c)   [ Time Frame: Baseline to Month 18 ]

25.  Secondary:

Percent Change From Baseline to Month 18 in HDL-2   [ Time Frame: Baseline to Month 18 ]

26.  Secondary:

Percent Change From Baseline to Month 18 in HDL-3   [ Time Frame: Baseline to Month 18 ]

27.  Secondary:

Percent Change From Baseline to Month 18 in Low Density Lipoprotein Cholesterol (LDL-c)   [ Time Frame: Baseline to Month 18 ]

28.  Secondary:

Percent Change From Baseline to Month 18 in Triglycerides (TG)   [ Time Frame: Baseline to Month 18 ]

29.  Secondary:

Percent Change From Baseline to Month 18 in Free Fatty Acids (FFA)   [ Time Frame: Baseline to Month 18 ]

30.  Secondary:

Percent Change From Baseline to Month 18 in Apoprotein B (apoB)   [ Time Frame: Baseline to Month 18 ]

31.  Secondary:

Change From Baseline to Month 18 in LDL-c Peak Particle Density Measured by LDL Relative Flotation   [ Time Frame: Baseline to Month 18 ]

32.  Secondary:

Change From Baseline to Month 18 in Total Cholesterol/HDL-c Ratio   [ Time Frame: Baseline to Month 18 ]

33.  Secondary:

Change From Baseline to Month 18 in LDL-c/HDL-c Ratio   [ Time Frame: Baseline to Month 18 ]

34.  Secondary:

Number of Participants With the Indicated Treatment Emergent Major Cardiovascular Events (MACE) for All-cause Death, Non-fatal MI, Non-fatal Stroke, Coronary Revascularization, or Hospitalization for Recurrent Myocardial Ischemia (MACE Composite 1)   [ Time Frame: Baseline to Month 21 ]

35.  Secondary:

Number of Participants With the Indicated Treatment Emergent Major Cardiovascular Events (MACE) for Cardiovascular Death, Nonfatal MI, or Nonfatal Stroke (MACE Composite 2)   [ Time Frame: Baseline to Month 21 ]

36.  Secondary:

Number of Other Cardiovascular Events   [ Time Frame: Baseline to Month 21 ]