Trial record 1 of 6 for:    vytorin and type 1 diabetes
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Clinical Trial of Zocor (Simvastatin) and Vytorin (Ezetimibe/Simvastatin) in Adolescents With Type 1 Diabetes

This study has been completed.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00477204
First received: May 21, 2007
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes Mellitus
Dyslipidemia
Drug: Simvastatin
Drug: Ezetimibe/Simvastatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Trial of Zocor and Vytorin in Adolescents With Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Change in LDL-c between Zocor and Vytorin treatment in subjects with Type 1 Diabetes measured at baseline to the 6-month study visit.


Secondary Outcome Measures:
  • No Secondary Outcomes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    No secondary outcomes were measured as recruitment was insufficient and study was stopped after only 9 subjects completed trial.


Enrollment: 9
Study Start Date: May 2007
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Vytorin

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

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477204

Locations
United States, Colorado
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: David M Maahs, MD University of Colorado, Denver
Principal Investigator: R. P Wadwa, MD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00477204     History of Changes
Other Study ID Numbers: 06-1036, K23DK075360
Study First Received: May 21, 2007
Results First Received: January 23, 2013
Last Updated: August 19, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Type 1 Diabetes Mellitus
dyslipidemia
adolescents

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Dyslipidemias
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Lipid Metabolism Disorders
Simvastatin
Ezetimibe
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 24, 2014