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

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 2

Conditions: Type 1 Diabetes Mellitus; Dyslipidemia

Treatments: Drug: Simvastatin; Drug: Ezetimibe/Simvastatin

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT00477204

K23DK075360 (U.S. NIH Grant/Contract)

06-1036

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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9 participants in 2 patient groups

Simvastatin

Active Comparator group

Description:

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

Treatment:

Drug: Simvastatin

Ezetimibe/Simvastatin

Active Comparator group

Description:

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

Treatment:

Drug: Ezetimibe/Simvastatin