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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Clinical Trial of Zocor and Vytorin in Adolescents With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00477204
• Other study ID #: 06-1036
• Secondary ID: K23DK075360
• Status: Completed
• Phase: Phase 2
• Start date: May 2007
• Est. completion date: August 2010

Study information

• Verified date: October 2020
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Dyslipidemia
• Dyslipidemias
• Type 1 Diabetes Mellitus

Intervention

Drug:
• Simvastatin
simvastatin 20 mg daily
• Ezetimibe/Simvastatin
Ezetimibe (10mg)/Simvastatin (20mg)

Locations

Country	Name	City	State
United States	Barbara Davis Center for Childhood Diabetes	Aurora	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	Merck Sharp & Dohme Corp., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in LDL-c From Baseline to 6 Months in Subjects With Type 1 Diabetes Taking Vytorin or Zocor.	Change in LDL-c between Zocor and Vytorin treatment in subjects with Type 1 Diabetes measured at baseline to the 6-month study visit.	Baseline to 6 months