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NCT Number: NCT00477204

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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Dyslipidemia Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

simvastatin

Drug

simvastatin 20 mg daily

Other names: Zocor

ezetimibe/simvastatin

Drug

Ezetimibe (10mg)/Simvastatin (20mg)

Other names: Vytorin

Primary outcomes

  1. Change in LDL-c From Baseline to 6 Months in Subjects With Type 1 Diabetes Taking Vytorin or Zocor.

    Time frame: Baseline to 6 months

    Change in LDL-c between Zocor and Vytorin treatment in subjects with Type 1 Diabetes measured at baseline to the 6-month study visit.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Merck Sharp & Dohme LLC
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
May 22, 2007
Registry last updated
Nov 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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