Trial Outcomes & Findings for Clinical Trial of Zocor (Simvastatin) and Vytorin (Ezetimibe/Simvastatin) in Adolescents With Type 1 Diabetes (NCT NCT00477204)

Last Updated: 2020-11-10

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

Baseline to 6 months

Results posted on

2020-11-10

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Ezetimibe/Simvastatin ezetimibe/simvastatin : ezetimibe/simvastatin 10/20 mg daily placebo for each medication	Simvastatin simvastatin: simvastatin 20 mg daily placebo for each medication
Overall Study STARTED	4	5
Overall Study COMPLETED	4	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vytorin n=4 Participants simvastatin, ezetimibe/simvastatin : simvastatin 20 mg daiy ezetimibe/simvastatin 10/20 mg daily placebo for each medication	Zocor n=5 Participants simvastatin, ezetimibe/simvastatin : simvastatin 20 mg daiy ezetimibe/simvastatin 10/20 mg daily placebo for each medication	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	13.7 years STANDARD_DEVIATION 1.8 • n=5 Participants	17.5 years STANDARD_DEVIATION 2.3 • n=7 Participants	15.8 years STANDARD_DEVIATION 2.8 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: Recruitment for this study failed to meet target. Due to the small sample size the analyses of these data were primarily descriptive.

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

Outcome measures

Outcome measures
Measure	Vytorin (Ezetimibe/Simvastatin) n=4 Participants ezetimibe/simvastatin : ezetimibe/simvastatin 10/20 mg daily placebo for each medication	Zocor (Simvastatin) n=5 Participants simvastatin: simvastatin 20 mg daily placebo for each medication
Change in LDL-c From Baseline to 6 Months in Subjects With Type 1 Diabetes Taking Vytorin or Zocor.	-67 mg/dl Standard Deviation 47	-6 mg/dl Standard Deviation 25

Adverse Events

Vytorin (Simvastatin + Ezetimibe)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Zocor [Simvastatin]

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Maahs, MD, PhD

University of Colorado Denver

Phone: 303-724-2323

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER