Clinical trial NCT00477204: Clinical Trial of Zocor (Simvastatin) and Vytorin (Ezetimibe/Simvastatin) in Adolescents With Type 1 Diabetes
Official title: Clinical Trial of Zocor and Vytorin in Adolescents With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 1 Diabetes Mellitus
Dyslipidemia
Keywords: Type 1 Diabetes Mellitus
dyslipidemia
adolescents
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2007-05-22
Enrollment: 9
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in LDL-c From Baseline to 6 Months in Subjects With Type 1 Diabetes Taking Vytorin or Zocor.
timeFrame: Baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Barbara Davis Center for Childhood Diabetes
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: David M Maahs, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: R. P Wadwa, MD
role: PRINCIPAL_INVESTIGATOR
References: