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

Sponsors and Collaborators:	Takeda Global Research & Development Center, Inc. The Cleveland Clinic
Information provided by:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00225277

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2 Coronary Artery Disease	Drug: pioglitazone HCl Drug: glimepiride	Phase III

MedlinePlus related topics: Coronary Artery Disease Diabetes Ultrasound

Drug Information available for: Pioglitazone Pioglitazone hydrochloride Glimepiride

U.S. FDA Resources

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

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:

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 Measures:

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 ]

Enrollment:	543
Study Start Date:	August 2003
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental pioglitazone HCl	Drug: pioglitazone HCl up to 45 mg pioglitazone HCl, tablet, orally, once daily for 18 months
2: Active Comparator glimepiride	Drug: glimepiride up to 4 mg of glimepiride, tablet, orally, once daily for 18 months

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.

Eligibility

Ages Eligible for Study:	35 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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%).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225277

Show 77 Study Locations

Sponsors and Collaborators

Takeda Global Research & Development Center, Inc.

The Cleveland Clinic

Investigators

Study Director:

Alfonso Perez, MD

Takeda Global Research & Development Center, Inc.

More Information

Publications indexed to this study:

Nissen SE, Nicholls SJ, Wolski K, Nesto R, Kupfer S, Perez A, Jure H, De Larochellière R, Staniloae CS, Mavromatis K, Saw J, Hu B, Lincoff AM, Tuzcu EM; PERISCOPE Investigators. Comparison of pioglitazone vs glimepiride on progression of coronary atherosclerosis in patients with type 2 diabetes: the PERISCOPE randomized controlled trial. JAMA. 2008 Apr 2;299(13):1561-73. Epub 2008 Mar 31.

Responsible Party:	Takeda Global Research & Development Center, Inc. ( VP, Clinical Science )
Study ID Numbers:	01-01-TL-OPI-516
Study First Received:	September 21, 2005
Last Updated:	May 9, 2008
ClinicalTrials.gov Identifier:	NCT00225277
Health Authority:	United States: Food and Drug Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Canada: Health Canada; Chile: Instituto de Salud Publica de Chile

Keywords provided by Takeda Global Research & Development Center, Inc.:

Diabetes Mellitus, Type 2
Atherosclerosis
Coronary artery disease

Study placed in the following topic categories:

Atherosclerosis
Arterial Occlusive Diseases
Heart Diseases
Metabolic Diseases
Pioglitazone
Myocardial Ischemia
Diabetes Mellitus
Disease Progression
Vascular Diseases
Endocrine System Diseases

Ischemia
Arteriosclerosis
Coronary Disease
Glimepiride
Diabetes Mellitus, Type 2
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Coronary Artery Disease

Additional relevant MeSH terms:

Hypoglycemic Agents
Immunologic Factors
Therapeutic Uses
Physiological Effects of Drugs
Cardiovascular Diseases

Cardiovascular Agents
Anti-Arrhythmia Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 06, 2009