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

Study Overview
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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.

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

Conditions
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Type 1 Diabetes Mellitus, Dyslipidemia

Intervention / Treatment
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* Drug: Simvastatin
* Drug: Ezetimibe/Simvastatin


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Simvastatin<br>Zocor(simvastatin)(20 mg)daily for 6 months along with Placebo (sugar pill)of active comparator (Vytorin [simvastatin] + Zetia [ezetimibe]. | Drug: Simvastatin<br>* simvastatin 20 mg daily<br>* Other names: Zocor;|
| Active Comparator: Ezetimibe/Simvastatin<br>Vytorin(simvastatin [Zocor} + ezetimibe [Zetia])(20 mg)daily for 6 months along with placebo (sugar pill)of comparator (Vytorin [simvastatin]). | Drug: Ezetimibe/Simvastatin<br>* Ezetimibe (10mg)/Simvastatin (20mg)<br>* Other names: Vytorin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in LDL-c From Baseline to 6 Months in Subjects With Type 1 Diabetes Taking Vytorin or Zocor. | Change in LDL-c between Zocor and Vytorin treatment in subjects with Type 1 Diabetes measured at baseline to the 6-month study visit. | Baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 Diabetes Mellitus, dyslipidemia, adolescents