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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

May 21, 2007
August 19, 2013
May 2007
August 2010   (final data collection date for primary outcome measure)
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.
LDL-c levels between Zocor and Vytorin treatment in subjects with Type 1 Diabetes. [ Time Frame: one year ]
Complete list of historical versions of study NCT00477204 on ClinicalTrials.gov Archive Site
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.
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. [ Time Frame: one year ]
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Type 1 Diabetes Mellitus
  • Dyslipidemia
  • Drug: Simvastatin
    simvastatin 20 mg daily
    Other Name: Zocor
  • Drug: Ezetimibe/Simvastatin
    Ezetimibe (10mg)/Simvastatin (20mg)
    Other Name: Vytorin
  • Active Comparator: Simvastatin
    Zocor(simvastatin)(20 mg)daily for 6 months along with Placebo (sugar pill)of active comparator (Vytorin [simvastatin] + Zetia [ezetimibe].
    Intervention: Drug: Simvastatin
  • Active Comparator: Ezetimibe/Simvastatin
    Vytorin(simvastatin [Zocor} + ezetimibe [Zetia])(20 mg)daily for 6 months along with placebo (sugar pill)of comparator (Vytorin [simvastatin]).
    Intervention: Drug: Ezetimibe/Simvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
August 2010
August 2010   (final data collection date for primary outcome measure)

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.
Both
12 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00477204
06-1036, K23DK075360
Yes
University of Colorado, Denver
University of Colorado, Denver
  • Merck Sharp & Dohme Corp.
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: David M Maahs, MD University of Colorado, Denver
Principal Investigator: R. P Wadwa, MD University of Colorado, Denver
University of Colorado, Denver
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP