Efficacy Study of Pioglitazone Compared to Glimepiride on Coronary Atherosclerotic Disease Progression in Subjects With Type 2 Diabetes Mellitus - Study Results

Efficacy Study of Pioglitazone Compared to Glimepiride on Coronary Atherosclerotic Disease Progression in Subjects With Type 2 Diabetes Mellitus (PERISCOPE)

This study has been completed.

Study NCT00225277 Information provided by Takeda Global Research & Development Center, Inc.

First Received: September 21, 2005 Last Updated: September 23, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Condition:	Diabetes Mellitus
Interventions:	Drug: Pioglitazone Drug: Glimepiride

Participant Flow

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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]	274 subjects randomized, but four subjects did not receive drug.
[2]	Mean treatment durations were 56.3 weeks (glimepiride) and 56.5 weeks (pioglitazone).

Baseline Characteristics

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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.

Baseline Measures

	Pioglitazone QD	Glimepiride QD	Total
Number of Participants [units: participants]	270	273	543
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	189	193	382
>=65 years	81	80	161
Gender [units: participants]
Female	84	93	177
Male	186	180	366
Ethnicity (NIH/OMB) [units: Participants]
Hispanic or Latino	63	71	134
Not Hispanic or Latino	207	202	409
Unknown or Not Reported	0	0	0
Race/Ethnicity, Customized [units: participants]
Native American	3	10	13
Asian	12	16	28
Black or African American	30	27	57
White	225	220	445
Family History of Coronary Artery Disease^[1] [units: Participants]
Male Relative History	91	77	168
Female Relative History	60	59	119
No Family History	119	137	256
Body Mass Index^[2] [units: Kg/m squared] Mean ( Full Range )	32.08 ( 21.1 to 49.3 )	32.03 ( 19.7 to 47.9 )	32.05 ( 19.7 to 49.3 )
Duration of Coronary Artery Disease^[3] [units: Months] Mean ( Full Range )	40.4 ( 0 to 378 )	40.5 ( 0 to 468 )	40.4 ( 0 to 468 )
Duration of Diabetes Mellitus^[4] [units: Months] Mean ( Full Range )	98.0 ( 0 to 624 )	96.3 ( 0 to 556 )	97.1 ( 0 to 624 )

[1]	Was first degree male or female relative diagnosed with Coronary Artery Disease at age < 55 years or < 65 years, respectively?
[2]	The mean for total was calculated as the weighted average of the means of the two treatment arms.
[3]	The mean for total was calculated as the weighted average of the means of the two treatment arms.
[4]	The mean for total was calculated as the weighted average of the means of the two treatment arms.

Outcome Measures

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Other Pre-specified:

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

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