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.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00225277
First received: September 21, 2005
Last updated: February 27, 2012
Last verified: February 2012
Results First Received: October 17, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Diabetes Mellitus
Interventions: Drug: Pioglitazone
Drug: Glimepiride

  Participant Flow
  Hide Participant Flow

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
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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.
Total Total of all reporting groups

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 [2]
[units: Months]
Mean ( Full Range )
  40.4  
  ( 0 to 378 )  
  40.5  
  ( 0 to 468 )  
  40.4  
  ( 0 to 468 )  
Duration of Diabetes Mellitus [2]
[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.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Nominal Change From Baseline in Percent Atheroma Volume   [ Time Frame: Baseline and Final Visit (up to 72 weeks) ]

2.  Secondary:   Nominal Change From Baseline in Normalized Total Atheroma Volume   [ Time Frame: Baseline and Final Visit (up to 72 weeks) ]

3.  Secondary:   Number of Subjects Experiencing Any of the Composite Endpoint A Cardiovascular Events   [ Time Frame: Up to 72 weeks ]

4.  Secondary:   Number of Subjects Experiencing Any of the Composite Endpoint B Cardiovascular Events   [ Time Frame: Up to 72 weeks ]

5.  Secondary:   Number of Subjects Experiencing Any of the Composite Endpoint C Cardiovascular Events   [ Time Frame: Up to 72 weeks ]

6.  Other Pre-specified:   Number of Cardiovascular Events as Adjudicated by the Clinical Endpoint Committee   [ Time Frame: Up to 72 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Composite Endpoints A,B,C include cardiovascular mortality, nonfatal MI and nonfatal stroke. In addition, B: coronary revascularization, carotid endarterectomy/stenting, unstable angina hosp. or CHF; C: hospitalization for unstable angina or CHF.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Sr. VP Clinical Sciences
Organization: Takeda Global Research and Development Center Inc.
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com


Publications of Results:
Nicholls,SJ, Tuzcu,EM, Wolski,K, Bayturan,O, Uno,K, Kupfer,SF, et al, Lowering the triglyceride/high-density lipoprotein cholesterol ratio is associated with the beneficial impact of pioglitazone on progression of coronary atherosclerosis in diabetic patients: insights from the PERISCOPE (pioglitazone effect on regression of intravascular sonographic coronary obstruction prospective evaluation) study. J Am Coll Cardiol 2011;57:(2):153-159.


Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00225277     History of Changes
Other Study ID Numbers: 01-01-TL-OPI-516, U1111-1114-0400
Study First Received: September 21, 2005
Results First Received: October 17, 2008
Last Updated: February 27, 2012
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile