Phase 2 N=9 Randomized Triple-blind Treatment

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

Type 1 Diabetes Mellitus · Dyslipidemia

Bottom Line

View on ClinicalTrials.gov: NCT00477204 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2013

Primary outcome: Primary: Change in LDL-c From Baseline to 6 Months in Subjects With Type 1 Diabetes Taking Vytorin or Zocor. — -67; -6 mg/dl

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Simvastatin (Drug); Ezetimibe/Simvastatin (Drug)
Age: Pediatric, Adult · 12+ yrs
Sex: All
Sponsor: University of Colorado, Denver
Primary completion: Aug 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in LDL-c From Baseline to 6 Months in Subjects With Type 1 Diabetes Taking Vytorin or Zocor.	-67; -6	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00477204). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.