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

Condition(s) targeted: Diabetes Mellitus, Type 2; Coronary Artery Disease

Intervention: pioglitazone HCl (Drug); glimepiride (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Takeda Global Research & Development Center, Inc.

Official(s) and/or principal investigator(s):
Alfonso Perez, MD, Study Director, Affiliation: Takeda Global Research & Development Center, Inc.

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.

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

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

Primary outcome: 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.

Secondary outcome:

Compare the effect of pioglitazone HCl and glimepiride on the nominal change in total atheroma volume

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.

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.

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).

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.

Minimum age: 35 Years. Maximum age: 85 Years. Gender(s): Both.

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%).

Multiple Cities, Argentina

Multiple Cities, Chile

Birmingham, Alabama, United States

Edmonton, Alberta, Canada

Phoenix, Arizona, United States

Victoria, British Columbia, Canada

Vancouver, British Columbia, Canada

Huntington Beach, California, United States

Los Angeles, California, United States

Sacramento, California, United States

San Diego, California, United States

Torrance, California, United States

Bridgeport, Connecticut, United States

Farmington, Connecticut, United States

Washington, District of Columbia, United States

Bay Pines, Florida, United States

Jacksonville, Florida, United States

Decatur, Georgia, United States

Boise, Idaho, United States

Chicago, Illinois, United States

Edgewood, Kentucky, United States

Lexington, Kentucky, United States

Louisville, Kentucky, United States

New Orleans, Louisiana, United States

Bangor, Maine, United States

Winnepeg, Manitoba, Canada

Baltimore, Maryland, United States

Detroit, Michigan, United States

Flint, Michigan, United States

Kalamazoo, Michigan, United States

Petoskey, Michigan, United States

Pontiac, Michigan, United States

Royal Oak, Michigan, United States

Ypsilanti, Michigan, United States

Duluth, Minnesota, United States

Minneapolis, Minnesota, United States

St. Cloud, Minnesota, United States

Columbia, Missouri, United States

Saint John, New Brunswick, Canada

Camden, New Jersey, United States

Albany, New York, United States

Bronx, New York, United States

Mineola, New York, United States

New York, New York, United States

Rochester, New York, United States

Troy, New York, United States

West Islip, New York, United States

Williamsville, New York, United States

Winston-Salem, North Carolina, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Westlake, Ohio, United States

Oklahoma City, Oklahoma, United States

Tulsa, Oklahoma, United States

London, Ontario, Canada

Ottawa, Ontario, Canada

Abington, Pennsylvania, United States

Bryn Mawr, Pennsylvania, United States

Hershey, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Montreal, Quebec, Canada

Sainte Foy, Quebec, Canada

Providence, Rhode Island, United States

Saskatoon, Saskatchewan, Canada

Greenville, South Carolina, United States

Memphis, Tennessee, United States

Oak Ridge, Tennessee, United States

Amarillo, Texas, United States

Houston, Texas, United States

Lubbock, Texas, United States

San Antonio, Texas, United States

Charlottesville, Virginia, United States

Norfolk, Virginia, United States

Richmond, Virginia, United States

Everett, Washington, United States

Green Bay, Wisconsin, United States

Starting date: August 2003
Ending date: November 2007
Last updated: May 9, 2008