Type 1 Diabetes MellitusPhase 2NCT00477204
Clinical Trial of Zocor (Simvastatin) and Vytorin (Ezetimibe/Simvastatin) in Adolescents With Type 1 Diabetes
A Phase 2 study testing Simvastatin and Ezetimibe/Simvastatin in people with Type 1 Diabetes Mellitus and Dyslipidemia, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Type 1 Diabetes Mellitus, Dyslipidemia
- What is being tested?
- Simvastatin and Ezetimibe/Simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Aug 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045
About this study
Official title: Clinical Trial of Zocor and Vytorin in Adolescents With Type 1 Diabetes
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.
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus, Dyslipidemia
- Being tested
- Simvastatin, Ezetimibe/Simvastatin
- Keywords
- Type 1 Diabetes Mellitus, dyslipidemia, adolescents
- Medical subject headings
- Diabetes Mellitus, Type 1, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
Also called Zocor
simvastatin 20 mg daily
Ezetimibe/SimvastatinDrug
Also called Vytorin
Ezetimibe (10mg)/Simvastatin (20mg)
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin | Active comparator | Zocor(simvastatin)(20 mg)daily for 6 months along with Placebo (sugar pill)of active comparator (Vytorin [simvastatin] + Zetia [ezetimibe]. Receives: 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]). Receives: Drug: Ezetimibe/Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2007 (estimated)
- Study startMay 2007
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- David M Maahs, MD, Principal investigator, University of Colorado, DenverR. P Wadwa, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477204
- Sponsor's protocol ID
- 06-1036
- Other IDs
- K23DK075360
- Status last verified
- Oct 2020
- First submitted
- 21 May 2007
- Last updated
- 10 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Zocor and Vytorin in Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT00477204
- Acronym / sponsor ID
- 06-1036
- Conditions
- Type 1 Diabetes Mellitus, Dyslipidemia
- Keywords
- Type 1 Diabetes Mellitus, dyslipidemia, adolescents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- May 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 22 May 2007 (estimated)
- Results
- Posted 21 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simvastatin | Active comparator | Drug: SimvastatinZocor(simvastatin)(20 mg)daily for 6 months along with Placebo (sugar pill)of active comparator (Vytorin [simvastatin] + Zetia [ezetimibe]. |
| Ezetimibe/Simvastatin | Active comparator | Drug: Ezetimibe/SimvastatinVytorin(simvastatin [Zocor} + ezetimibe [Zetia])(20 mg)daily for 6 months along with placebo (sugar pill)of comparator (Vytorin [simvastatin]). |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SimvastatinAlso: Zocorsimvastatin 20 mg daily | Drug | Simvastatin |
| Ezetimibe/SimvastatinAlso: VytorinEzetimibe (10mg)/Simvastatin (20mg) | Drug | Ezetimibe/Simvastatin |
Primary outcome
Change in LDL-c From Baseline to 6 Months in Subjects With Type 1 Diabetes Taking Vytorin or Zocor.
Time frame: Baseline to 6 months
Change in LDL-c between Zocor and Vytorin treatment in subjects with Type 1 Diabetes measured at baseline to the 6-month study visit.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David M Maahs, MD principal investigator
University of Colorado, Denver
R. P Wadwa, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Simvastatin and Ezetimibe/Simvastatin in people with Type 1 Diabetes Mellitus and Dyslipidemia, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in LDL-c From Baseline to 6 Months in Subjects With Type 1 Diabetes Taking Vytorin or Zocor. (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.