Clinical Trial of Zocor and Vytorin in Adolescents With Type 1 Diabetes - Full Text View

Sponsor:	University of Colorado, Denver
Collaborators:	Merck National Institutes of Health (NIH)
Information provided by:	University of Colorado, Denver
ClinicalTrials.gov Identifier:	NCT00477204

Purpose

The purpose of the study is to establish the safety of Zocor and Vytorin in adolescents with Type 1 Diabetes and to determine the amount of decrease in LDL-cholesterol.The study hypothesizes that Zocor and Vytorin will be safe in adolescents with Type 1 Diabetes and will lower LDL-cholesterol at 6 months.

Condition	Intervention	Phase
Type 1 Diabetes Mellitus Dyslipidemia	Drug: Zocor (simvastatin), Vytorin (ezetimibe/simvastatin)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Clinical Trial of Zocor and Vytorin in Adolescents With Type 1 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Simvastatin Ezetimibe Vytorin

U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:

LDL-c levels between Zocor and Vytorin treatment in subjects with Type 1 Diabetes. [ Time Frame: one year ]

Secondary Outcome Measures:

HgbA1c, lipid panel, vertical auto profile (VAP), creatinine kinase, Liver function tests, thyroid function, CRP, arterial stiffness measurements, insulin dose, diabetes duration, continuous glucose measurement, and blood pressure. [ Time Frame: one year ]

Estimated Enrollment:	82
Study Start Date:	May 2007
Estimated Study Completion Date:	October 2008

Detailed Description:

Cardiovascular disease is the leading cause of death in people with type 1 diabetes mellitus (T1DM) and since atherosclerosis begins in childhood, data to inform clinicians as to appropriate dyslipidemia treatment in this high-risk population are of great public health importance. In this trial of lipid-lowering medications (Zocor [simvastatin], a statin, compared to Vytorin [ezetimibe/simvastatin], a combination of a statin and Zetia, a medication that blocks cholesterol absorption) will be performed in patients ages 12-18 years with LDL ≥ 130 mg/dl, consistent with current ADA guidelines. The study hypothesizes that Zocor and Vytorin will be safe in adolescents with T1DM and will lower LDL-cholesterol at 6 months compared to baseline. In a two-arm design, Vytorin will lower LDL-c more than monotherapy with Zocor.

Eligibility

Ages Eligible for Study:	12 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

12-18 years of age with Type 1 Diabetes and seen at the Barbara Davis Center for Childhood Diabetes
Positive diabetes auto-antibodies or provider diagnosed Type 1 Diabetes
LDL > 130 mg/dl.

Exclusion Criteria:

Familial hypercholesterolemia, TG > 400mg/dl
Type 1 Diabetes of less than three-month duration
HbA1c>9.5%
Abnormal thyroid function
Abnormal CK values (defined as > 10X the upper limit of normal)
Abnormal liver function tests (ALT/AST) (defined as >3X the upper limit of normal)
Pregnancy, and patients on oral contraceptives
All resources are in English. Spanish speakers will not be available for the follow-up calls.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477204

Contacts

Contact: Franziska K Bishop, MS	3037246764	franziska.bishop@uchsc.edu
Contact: David M Maahs, MD	3037246706	david.maahs@uchsc.edu

Locations

United States, Colorado
Barbara Davis Center for Childhood Diabetes	Recruiting
Aurora, Colorado, United States, 80045

Sponsors and Collaborators

University of Colorado, Denver

Merck

National Institutes of Health (NIH)

Investigators

Principal Investigator:	David M Maahs, MD	University of Colorado, Denver
Principal Investigator:	R. Paul Wadwa, MD	University of Colorado, Denver

More Information

No publications provided

Study ID Numbers:	06-1036, 843
Study First Received:	May 21, 2007
Last Updated:	May 21, 2007
ClinicalTrials.gov Identifier:	NCT00477204 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:

Type 1 Diabetes Mellitus
dyslipidemia
adolescents

Additional relevant MeSH terms:

Diabetes Mellitus, Type 1
Diabetes Mellitus
Antimetabolites
Metabolic Diseases
Autoimmune Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents

Endocrine System Diseases
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Therapeutic Uses
Glucose Metabolism Disorders
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010