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

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborators: Merck Sharp & Dohme Corp.; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Ezetimibe; Ezetimibe, Simvastatin Drug Combination; Simvastatin

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.