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

Phase 2

Completed

• Conditions: Dyslipidemia; Type 1 Diabetes Mellitus
• Interventions: Drug: Ezetimibe/Simvastatin; Drug: Simvastatin

• Registration Number: NCT00477204
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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

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 Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-21
• Study First Submitted QC: 2007-05-21
• Study First Posted: 2007-05-22
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Results First Submitted: 2013-01-23
• Results First Submitted QC: 2013-06-18
• Results First Posted: 2013-06-21
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-19
• Last Update Posted: 2020-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ezetimibe/Simvastatin	Ezetimibe/Simvastatin	Vytorin(simvastatin \[Zocor} + ezetimibe \[Zetia\])(20 mg)daily for 6 months along with placebo (sugar pill)of comparator (Vytorin \[simvastatin\]).
Simvastatin	Simvastatin	Zocor(simvastatin)(20 mg)daily for 6 months along with Placebo (sugar pill)of active comparator (Vytorin \[simvastatin\] + Zetia \[ezetimibe\].

Primary Outcome Measures

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

Trial Locations

Locations (1)

Barbara Davis Center for Childhood Diabetes; 🇺🇸 Aurora, Colorado, United States