Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled at 97 sites in the United States, Canada, Argentina and Chile from 21 July 2003 to 18 October 2007.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The participant flow results below do not include 4 subjects who were randomized but did not receive drug. Subjects participating in this study were enrolled in Pioglitazone or Glimepiride once daily (QD) treatment group.

Reporting Groups

	Description
Pioglitazone QD	Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
Glimepiride QD	Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.

Participant Flow:   Overall Study

	Pioglitazone QD	Glimepiride QD
STARTED	274[1]	273[2]
COMPLETED	177	178
NOT COMPLETED	97	95
Adverse Event	30	34
Lack of Efficacy	4	1
Lost to Follow-up	4	6
Physician Decision	6	8
Protocol Violation	6	3
Withdrawal by Subject	40	34
Other	7	9

1.  Primary:

Nominal Change From Baseline in Percent Atheroma Volume   [ Baseline and Final Visit (up to 72 weeks) ]

2.  Secondary:

Nominal Change From Baseline in Normalized Total Atheroma Volume   [ Baseline and Final Visit (up to 72 weeks) ]

3.  Secondary:

Number of Subjects Experiencing Any of the Composite Endpoint A Cardiovascular Events   [ Up to 72 weeks ]

4.  Secondary:

Number of Subjects Experiencing Any of the Composite Endpoint B Cardiovascular Events   [ Up to 72 weeks ]

5.  Secondary:

Number of Subjects Experiencing Any of the Composite Endpoint C Cardiovascular Events   [ Up to 72 weeks ]

6.  Other Pre-specified:

Number of Cardiovascular Events as Adjudicated by the Clinical Endpoint Committee   [ Up to 72 weeks ]