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

Primary Purpose

Type 1 Diabetes Mellitus, Dyslipidemia

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Simvastatin

Ezetimibe/Simvastatin

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Type 1 Diabetes Mellitus, dyslipidemia, adolescents

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Barbara Davis Center for Childhood Diabetes

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Simvastatin

Ezetimibe/Simvastatin

Arm Description

Zocor(simvastatin)(20 mg)daily for 6 months along with Placebo (sugar pill)of active comparator (Vytorin [simvastatin] + Zetia [ezetimibe].

Vytorin(simvastatin [Zocor} + ezetimibe [Zetia])(20 mg)daily for 6 months along with placebo (sugar pill)of comparator (Vytorin [simvastatin]).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00477204

First Posted

May 21, 2007

Last Updated

October 19, 2020

Sponsor

University of Colorado, Denver

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00477204

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Colorado, Denver

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus, Dyslipidemia

Keywords

Type 1 Diabetes Mellitus, dyslipidemia, adolescents

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Simvastatin

Arm Type

Active Comparator

Arm Description

Zocor(simvastatin)(20 mg)daily for 6 months along with Placebo (sugar pill)of active comparator (Vytorin [simvastatin] + Zetia [ezetimibe].

Arm Title

Ezetimibe/Simvastatin

Arm Type

Active Comparator

Arm Description

Vytorin(simvastatin [Zocor} + ezetimibe [Zetia])(20 mg)daily for 6 months along with placebo (sugar pill)of comparator (Vytorin [simvastatin]).

Intervention Type

Drug

Intervention Name(s)

Simvastatin

Other Intervention Name(s)

Zocor

Intervention Description

simvastatin 20 mg daily

Intervention Type

Drug

Intervention Name(s)

Ezetimibe/Simvastatin

Other Intervention Name(s)

Vytorin

Intervention Description

Ezetimibe (10mg)/Simvastatin (20mg)

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Baseline to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David M Maahs, MD

Organizational Affiliation

University of Colorado, Denver

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

R. P Wadwa, MD

Organizational Affiliation

University of Colorado, Denver

Official's Role

Principal Investigator

Facility Information:

Facility Name

Barbara Davis Center for Childhood Diabetes

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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