NCT00477204

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2007

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

June 21, 2013

Completed
Last Updated

November 10, 2020

Status Verified

October 1, 2020

Enrollment Period

3.3 years

First QC Date

May 21, 2007

Results QC Date

January 23, 2013

Last Update Submit

October 19, 2020

Conditions

Type 1 Diabetes MellitusDyslipidemia

Keywords

Type 1 Diabetes Mellitusdyslipidemiaadolescents

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Simvastatin

ACTIVE COMPARATOR

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

Drug: Simvastatin

Ezetimibe/Simvastatin

ACTIVE COMPARATOR

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

Drug: Ezetimibe/Simvastatin

Interventions

SimvastatinDRUG

simvastatin 20 mg daily

Also known as: Zocor
Simvastatin
Ezetimibe/SimvastatinDRUG

Ezetimibe (10mg)/Simvastatin (20mg)

Also known as: Vytorin
Ezetimibe/Simvastatin

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Dyslipidemias

Interventions

SimvastatinEzetimibe, Simvastatin Drug Combination

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsEzetimibeAzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Limitations and Caveats

Recruitment for this study failed to meet target and therefore it is difficult to make conclusions on the data obtained in these 9 subjects. No secondary outcomes were measured as recruitment was insufficient and study was stopped after only 9 subjects completed trial.

Results Point of Contact

Title
David Maahs, MD, PhD
Organization
University of Colorado Denver
david.maahs@ucdenver.edu
303-724-2323

Study Officials

  • David M Maahs, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

  • R. P Wadwa, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2007

First Posted

May 22, 2007

Study Start

May 1, 2007

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

November 10, 2020

Results First Posted

June 21, 2013

Record last verified: 2020-10

Locations

US(1)