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

Completed · Phase 2

Conditions studied: Type 1 Diabetes Mellitus, Dyslipidemia

In brief

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.

Key facts

Study ID

NCT00477204

Run by

University of Colorado, Denver

People needed

9

Starts

2007-05-01

Expected to finish

2010-08-01

Last updated by the study team

2020-11-10

Who can join

Age: 12 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Barbara Davis Center for Childhood Diabetes — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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