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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00477204
Recruitment Status : Completed
First Posted : May 22, 2007
Results First Posted : June 21, 2013
Last Update Posted : August 28, 2013
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Colorado, Denver

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Type 1 Diabetes Mellitus
Dyslipidemia
Interventions Drug: Simvastatin
Drug: Ezetimibe/Simvastatin
Enrollment 9
Recruitment Details Dates of recruitment: baseline 12/20/07-2/9/10; all participants completed 6-month trial by 8/3/10. All study participants seen at a medical clinic in an area designated for clinical research.
Pre-assignment Details We identified 105 potential subjects. Of these, 42 patients proved to be ineligible, 26 declined invitation to a screening visit, 16 were not able to be scheduled, and 3 were interested but ineligible for the study. Therefore, 18 agreed to be in the study and 17 subjects attended a study screening visit of which 9 were enrolled in the study.
Arm/Group Title Ezetimibe/Simvastatin Simvastatin
Hide Arm/Group Description ezetimibe/simvastatin : ezetimibe/simvastatin 10/20 mg daily placebo for each medication

simvastatin: simvastatin 20 mg daily

placebo for each medication

Period Title: Overall Study
Started 4 5
Completed 4 5
Not Completed 0 0
Arm/Group Title Vytorin Zocor Total
Hide Arm/Group Description simvastatin, ezetimibe/simvastatin : simvastatin 20 mg daiy ezetimibe/simvastatin 10/20 mg daily placebo for each medication simvastatin, ezetimibe/simvastatin : simvastatin 20 mg daiy ezetimibe/simvastatin 10/20 mg daily placebo for each medication Total of all reporting groups
Overall Number of Baseline Participants 4 5 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
<=18 years
4
 100.0%
5
 100.0%
9
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 5 participants 9 participants
13.7  (1.8) 17.5  (2.3) 15.8  (2.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
Female
1
  25.0%
3
  60.0%
4
  44.4%
Male
3
  75.0%
2
  40.0%
5
  55.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 5 participants 9 participants
4 5 9
1.Primary Outcome
Title Change in LDL-c From Baseline to 6 Months in Subjects With Type 1 Diabetes Taking Vytorin or Zocor.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Recruitment for this study failed to meet target. Due to the small sample size the analyses of these data were primarily descriptive.
Arm/Group Title Vytorin (Ezetimibe/Simvastatin) Zocor (Simvastatin)
Hide Arm/Group Description:
ezetimibe/simvastatin : ezetimibe/simvastatin 10/20 mg daily placebo for each medication

simvastatin: simvastatin 20 mg daily

placebo for each medication

Overall Number of Participants Analyzed 4 5
Mean (Standard Deviation)
Unit of Measure: mg/dl
-67  (47) -6  (25)
2.Secondary Outcome
Title No Secondary Outcomes
Hide Description No secondary outcomes were measured as recruitment was insufficient and study was stopped after only 9 subjects completed trial.
Time Frame 6 months
Outcome Measure Data Not Reported
Time Frame All Serious Adverse Events (SAEs) will be reported to the Clinical Translational Research Center (CTRC), Data Safety Monitoring Board (DSMB), Research Subject Advocate (RSA) and the Colorado Multiple Institutional Review Board (COMIRB) within 5 days
Adverse Event Reporting Description SAEs will also be reported to the FDA since this protocol is under an Investigational New Drug (IND). Adverse Events (AEs) will be batched and reported to the DSMB as part of the periodic reports and to COMIRB at the time of continuing review.
 
Arm/Group Title Vytorin (Simvastatin + Ezetimibe) Zocor [Simvastatin]
Hide Arm/Group Description Vytorin [simvastatin + ezetimibe]20 mg taken daily for 6 months to compare in a 2- arm design to Zocor [simvastatin] . Zocor [simvastatin] 20 mg taken daily for 6 months to compare in a 2- arm design to Vytorin [simvastatin + ezetimibe].
All-Cause Mortality
Vytorin (Simvastatin + Ezetimibe) Zocor [Simvastatin]
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vytorin (Simvastatin + Ezetimibe) Zocor [Simvastatin]
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vytorin (Simvastatin + Ezetimibe) Zocor [Simvastatin]
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/5 (0.00%) 
Recruitment for this study failed to meet target and therefore it is difficult to make conclusions on the data obtained in these 9 subjects.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to the sponsor for review.
Results Point of Contact
Name/Title: David Maahs, MD, PhD
Organization: University of Colorado Denver
Phone: 303-724-2323
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00477204     History of Changes
Other Study ID Numbers: 06-1036
K23DK075360 ( U.S. NIH Grant/Contract )
First Submitted: May 21, 2007
First Posted: May 22, 2007
Results First Submitted: January 23, 2013
Results First Posted: June 21, 2013
Last Update Posted: August 28, 2013