Pioglitazone Effect on Regression of Intravascular Sonographic Coronary Obstruction Prospective Evaluation (PERISCOPE) - Tabular View

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Pioglitazone Effect on Regression of Intravascular Sonographic Coronary Obstruction Prospective Evaluation (PERISCOPE)

This study has been completed.
Information provided by Takeda Global Research & Development Center, Inc.

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Pioglitazone Effect on Regression of Intravascular Sonographic Coronary Obstruction Prospective Evaluation (PERISCOPE)

Official Title ^†

A Double-Blind, Randomized, Comparator-Controlled Study In Subjects With Type 2 Diabetes Mellitus Comparing the Effects of Pioglitazone HCl Versus Glimepiride on the Rate of Progression of Coronary Atherosclerotic Disease as Measured by Intravascular Ultrasound

Brief Summary

The primary purpose of this study is to compare the effect of pioglitazone HCl versus glimepiride on the coronary atheroma volume using IVUS of the coronary arteries after up to 18 months of treatment.

Detailed Description

Subjects with type 2 diabetes requiring angiography will have the IVUS procedure performed at baseline and again following 18 months of treatment. Subjects who meet eligibility criteria will be titrated up to a maximum of 45 mg/day pioglitazone HCl or 4 mg/day glimepiride. Subjects will make 11 visits to the study center. During study visits, subjects will have weight, and vital signs assessed as well as abdominal and hip girth. Physical exams will be done at baseline, 12 months, and 18 months. ECG will be done at baseline and 18 months. Lab assessments will be done at each visit. Completed blood count, chemistries, urinalysis and markers of atherosclerosis will be drawn at baseline, and months 6, 12 and 18. At each visit, information will be collected regarding adverse events the subject may have experienced and any medications the subject is taking. Compliance with study medication will also be assessed at each visit.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Effect of treatment on the nominal change in percent atheroma volume of the identified target coronary artery segment from baseline after 18 months of treatment as measured by intravascular ultrasound (IVUS) imaging of the coronary arteries. [ Time Frame: 18 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measure ^†

Compare the effect of pioglitazone HCl and glimepiride on the nominal change in total atheroma volume [ Time Frame: 18 Months ] [ Designated as safety issue: Yes ]
Compare the effect of pioglitazone HCl and glimepiride on the occurrence of cardiovascular events as a composite of cardiovascular mortality, nonfatal myocardial infarction, nonfatal stroke. [ Time Frame: 18 Months ] [ Designated as safety issue: Yes ]
Compare the effect of pioglitazone HCl and glimepiride on the occurrence of cardiovascular events as a composite of cardiovascular mortality, nonfatal MI, nonfatal stroke and coronary revascularization. [ Time Frame: 18 Months ] [ Designated as safety issue: Yes ]
Compare the effect of pioglitazone HCl and glimepiride on the occurrence of carotid endarterectomy/carotid stenting, hospitalization for unstable angina, and hospitalization for congestive heart failure (CHF). [ Time Frame: 18 Months ] [ Designated as safety issue: Yes ]

Condition ^†

Diabetes Mellitus, Type 2
Coronary Artery Disease

Intervention ^†

Drug: pioglitazone HCl
Drug: glimepiride

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

543

Start Date ^†

August 2003

Completion Date

November 2007

Eligibility Criteria ^†

Inclusion Criteria:

Subjects between the ages of 35 and 85 years, inclusive.
Subjects with type 2 diabetes and coronary artery disease requiring an angiogram.
Subjects with HbA1c > 6.0% and <9% if taking antidiabetic medications, or HbA1c > 6.5% and <10% if not taking antidiabetic medication.

Exclusion Criteria:

Subjects with type 1 diabetes.
Subjects taking more than three antidiabetic therapies.
Subjects taking thiazolidinediones (TZDs) currently or within 12 weeks prior to randomization.
Subjects with New York Heart Association Class III or IV cardiac failure or left ventricular dysfunction (left ventricular ejection fraction <40%).

Gender

Both

Ages

35 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Argentina, Canada, Chile

Administrative Information Fields

NCT ID ^†

NCT00225277

Organization ID

01-01-TL-OPI-516

Secondary IDs ^††

Study Sponsor ^†

Takeda Global Research & Development Center, Inc.

Collaborators ^††

The Cleveland Clinic

Investigators ^†

Study Director:

Alfonso Perez, MD

Takeda Global Research & Development Center, Inc.

Information Provided By

Takeda Global Research & Development Center, Inc.

Verification Date

May 2008

First Received Date ^†

September 21, 2005

Last Updated Date

May 9, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.