Clinical Trial of Zocor and Vytorin in Adolescents With Type 1 Diabetes

This study has been completed.

Sponsor:

Collaborators:

Merck

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

Information provided by (Responsible Party):

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT00477204

First received: May 21, 2007

Last updated: December 11, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 21, 2007

Last Updated Date

December 11, 2012

Start Date ^ICMJE

May 2007

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

LDL-c levels between Zocor and Vytorin treatment in subjects with Type 1 Diabetes. [ Time Frame: one year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00477204 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Clinical Trial of Zocor and Vytorin in Adolescents With Type 1 Diabetes

Official Title ^ICMJE

Clinical Trial of Zocor and Vytorin in Adolescents With Type 1 Diabetes

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Type 1 Diabetes Mellitus
Dyslipidemia

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: Zocor
Intervention: Drug: simvastatin, ezetimibe/simvastatin
Active Comparator: Vytorin
Intervention: Drug: simvastatin, ezetimibe/simvastatin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2010

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

12 Years to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00477204

Other Study ID Numbers ^ICMJE

06-1036, K23DK075360

Has Data Monitoring Committee

Yes

Responsible Party

University of Colorado, Denver

Study Sponsor ^ICMJE

University of Colorado, Denver

Collaborators ^ICMJE

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

Investigators ^ICMJE

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

Information Provided By

University of Colorado, Denver

Verification Date

September 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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