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Clinical Trial of Zocor (Simvastatin) and Vytorin (Ezetimibe/Simvastatin) in Adolescents With Type 1 Diabetes

NCT ID: NCT00477204

Last Updated: 2020-11-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2010-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Type 1 Diabetes Mellitus Dyslipidemia

Keywords

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Type 1 Diabetes Mellitus dyslipidemia adolescents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Simvastatin

Zocor(simvastatin)(20 mg)daily for 6 months along with Placebo (sugar pill)of active comparator (Vytorin \[simvastatin\] + Zetia \[ezetimibe\].

Group Type ACTIVE_COMPARATOR

Simvastatin

Intervention Type DRUG

simvastatin 20 mg daily

Ezetimibe/Simvastatin

Vytorin(simvastatin \[Zocor} + ezetimibe \[Zetia\])(20 mg)daily for 6 months along with placebo (sugar pill)of comparator (Vytorin \[simvastatin\]).

Group Type ACTIVE_COMPARATOR

Ezetimibe/Simvastatin

Intervention Type DRUG

Ezetimibe (10mg)/Simvastatin (20mg)

Interventions

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Simvastatin

simvastatin 20 mg daily

Intervention Type DRUG

Ezetimibe/Simvastatin

Ezetimibe (10mg)/Simvastatin (20mg)

Intervention Type DRUG

Other Intervention Names

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Zocor Vytorin

Eligibility Criteria

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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, Triglycerides (TG) \> 400mg/dl
* Type 1 Diabetes of less than three-month duration
* HbA1c\>9.5%
* Abnormal thyroid function
* Abnormal Creatine Kinase (CK) values (defined as \> 10 times the upper limit of normal)
* Abnormal liver function tests (ALT/AST) (defined as \>3 times 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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

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

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David M Maahs, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

R. P Wadwa, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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K23DK075360

Identifier Type: NIH

Identifier Source: secondary_id

View Link

06-1036

Identifier Type: -

Identifier Source: org_study_id