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

Clinical Trial of Zocor and Vytorin 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.

Study Overview

• Status: Completed
• Conditions: Dyslipidemia; Type 1 Diabetes Mellitus
• Intervention / Treatment: Drug: Simvastatin; Drug: Ezetimibe/Simvastatin

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Barbara Davis Center for Childhood Diabetes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Simvastatin; Zocor(simvastatin)(20 mg)daily for 6 months along with Placebo (sugar pill)of active comparator (Vytorin [simvastatin] + Zetia [ezetimibe].	Drug: Simvastatin; simvastatin 20 mg daily; Other Names: Zocor
Active Comparator: Ezetimibe/Simvastatin; Vytorin(simvastatin [Zocor} + ezetimibe [Zetia])(20 mg)daily for 6 months along with placebo (sugar pill)of comparator (Vytorin [simvastatin]).	Drug: Ezetimibe/Simvastatin; Ezetimibe (10mg)/Simvastatin (20mg); Other Names: Vytorin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: David M Maahs, MD, University of Colorado, Denver; Principal Investigator: R. P Wadwa, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: May 21, 2007
• First Submitted That Met QC Criteria: May 21, 2007
• First Posted (Estimate): May 22, 2007

Study Record Updates

• Last Update Posted (Actual): November 10, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: adolescents; Type 1 Diabetes Mellitus; dyslipidemia
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Lipid Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 1; Dyslipidemias; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Simvastatin; Ezetimibe; Ezetimibe, Simvastatin Drug Combination
• Other Study ID Numbers: 06-1036; K23DK075360 (U.S. NIH Grant/Contract)