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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK075360 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simvastatin | Active Comparator | Zocor(simvastatin)(20 mg)daily for 6 months along with Placebo (sugar pill)of active comparator (Vytorin [simvastatin] + Zetia [ezetimibe]. |
|
| Ezetimibe/Simvastatin | Active Comparator | Vytorin(simvastatin [Zocor} + ezetimibe [Zetia])(20 mg)daily for 6 months along with placebo (sugar pill)of comparator (Vytorin [simvastatin]).](streamdown:incomplete-link) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin | Drug | simvastatin 20 mg daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David M Maahs, MD | University of Colorado, Denver | Principal Investigator |
| R. P Wadwa, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Davis Center for Childhood Diabetes | Aurora | Colorado | 80045 | United States |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ezetimibe/Simvastatin | ezetimibe/simvastatin : ezetimibe/simvastatin 10/20 mg daily placebo for each medication |
| FG001 | Simvastatin | simvastatin: simvastatin 20 mg daily placebo for each medication |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vytorin | simvastatin, ezetimibe/simvastatin : simvastatin 20 mg daiy ezetimibe/simvastatin 10/20 mg daily placebo for each medication |
| BG001 | Zocor | simvastatin, ezetimibe/simvastatin : simvastatin 20 mg daiy ezetimibe/simvastatin 10/20 mg daily placebo for each medication |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Recruitment for this study failed to meet target. Due to the small sample size the analyses of these data were primarily descriptive. | Posted | Mean | Standard Deviation | mg/dl | Baseline to 6 months |
|
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
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vytorin (Simvastatin + Ezetimibe) | Vytorin [simvastatin + ezetimibe]20 mg taken daily for 6 months to compare in a 2- arm design to Zocor [simvastatin] . |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Maahs, MD, PhD | University of Colorado Denver | 303-724-2323 | david.maahs@ucdenver.edu |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| D000069499 | Ezetimibe, Simvastatin Drug Combination |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Ezetimibe/Simvastatin | Drug | Ezetimibe (10mg)/Simvastatin (20mg) |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Zocor [Simvastatin] | Zocor [simvastatin] 20 mg taken daily for 6 months to compare in a 2- arm design to Vytorin [simvastatin + ezetimibe]. | 0 | 5 | 0 | 5 |
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.
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D052439 | Lipid Metabolism Disorders |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000069438 | Ezetimibe |
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |