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

Sponsor:	University of Colorado, Denver
Collaborators:	Merck National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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: simvastatin, ezetimibe/simvastatin	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Clinical Trial of Zocor and Vytorin in Adolescents With Type 1 Diabetes

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Enrollment:	9
Study Start Date:	May 2007
Study Completion Date:	August 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Zocor	Drug: simvastatin, ezetimibe/simvastatin simvastatin 20 mg daiy ezetimibe/simvastatin 10/20 mg daily placebo for each medication Other Names: Zocor = simvastatin Vytorin = ezetimibe/simvastatin
Active Comparator: Vytorin	Drug: simvastatin, ezetimibe/simvastatin simvastatin 20 mg daiy ezetimibe/simvastatin 10/20 mg daily placebo for each medication Other Names: Zocor = simvastatin Vytorin = ezetimibe/simvastatin

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

Locations

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

Sponsors and Collaborators

University of Colorado, Denver

Merck

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

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

More Information

No publications provided

Responsible Party:	David Maahs, MD, University of Colorado
ClinicalTrials.gov Identifier:	NCT00477204 History of Changes
Other Study ID Numbers:	06-1036, K23DK075360
Study First Received:	May 21, 2007
Last Updated:	September 23, 2010
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
Diabetes Mellitus, Type 1
Dyslipidemias
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Lipid Metabolism Disorders
Simvastatin

Ezetimibe
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012