Clinical Trial of Zocor and Vytorin in Adolescents With Type 1 Diabetes
Information source: University of Colorado at Denver and Health Sciences Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 1 Diabetes Mellitus; Dyslipidemia
Intervention: Zocor (simvastatin), Vytorin (ezetimibe/simvastatin) (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of Colorado at Denver and Health Sciences Center Official(s) and/or principal investigator(s):
David M Maahs, MD, Principal Investigator, Affiliation: University of Colorado at Denver and Health Sciences Center
R. Paul Wadwa, MD, Principal Investigator, Affiliation: University of Colorado at Denver and Health Sciences Center
Overall contact:
Franziska K Bishop, MS, Phone: 3037246764, Email: franziska.bishop@uchsc.edu
Summary
The purpose of the study is to establish the safety of Zocor and Vytorin in adolescents
with Type 1 Diabetes and to determine the amount of decrease in LDL-cholesterol. The study
hypothesizes that Zocor and Vytorin will be safe in adolescents with Type 1 Diabetes and
will lower LDL-cholesterol at 6 months.
Clinical Details
Official title: Clinical Trial of Zocor and Vytorin in Adolescents With Type 1 Diabetes
Study design: Treatment, Randomized, Double-Blind, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Primary outcome: LDL-c levels between Zocor and Vytorin treatment in subjects with Type 1 Diabetes.
Secondary outcome: HgbA1c, lipid panel, vertical auto profile (VAP), creatinine kinase, Liver function tests, thyroid function, CRP, arterial stiffness measurements, insulin dose, diabetes duration, continuous glucose measurement, and blood pressure.
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
Minimum age: 12 Years.
Maximum age: 18 Years.
Gender(s): Both.
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, TG > 400mg/dl
- Type 1 Diabetes of less than three-month duration
- HbA1c>9. 5%
- Abnormal thyroid function
- Abnormal CK values (defined as > 10X the upper limit of normal)
- Abnormal liver function tests (ALT/AST) (defined as >3X 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.
Locations and Contacts
Franziska K Bishop, MS, Phone: 3037246764, Email: franziska.bishop@uchsc.edu
Barbara Davis Center for Childhood Diabetes, Aurora, Colorado 80045, United States; Recruiting
Additional Information
Starting date: May 2007
Ending date: October 2008
Last updated: May 21, 2007
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