Diabetes Mellitus and HypercholesterolemiaPhase 4NCT03217409
A Study to Compare Rosuvastatin/Ezetimibe and Rosuvastatin in Patients With Diabetes Mellitus and Hypercholesterolemia
A Phase 4 study testing Rosuvastatin+Ezetimibe and Rosuvastatin in people with Diabetes Mellitus and Hypercholesterolemia, run by Yuhan Corporation at 4 sites in South Korea.
Trial summary
A Study to Compare Rosuvastatin/Ezetimibe Combination and Monotherapy in Patients with Diabetes Mellitus and Hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Diabetes Mellitus and Hypercholesterolemia
- What is being tested?
- Rosuvastatin+Ezetimibe and Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 10 Aug 2017to 23 May 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects ≥ 19 or ≤ 75 years of age
- Subjects undergoing treatment for type 2 diabetes
- Subjects undergoing treatment of statin for hypercholesterolemia
- Fasting LDL-C ≤ 250mg/dL at the screening visit
- Fasting LDL-C ≥70mg/dL or ≤ 160mg/dL at the randomization visit
- Fasting TG<500mg/dL
Who cannot join
- Subjects with hypersensitivity reaction to Statin and Ezetimibe
- Subjects with severe kidney disease
- Subjects with HIV positive result at the screening
- Pregnant or breast-feeding subjects
- Subjects with taking any medication affecting level of LDL (Fenofibrate, Omega 3 fatty aicd etc.)
- Insulin-treated Subjects
- Other exclusions applied
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Soon Chun Hyang University Hospital Cheonan
Cheonan
Soon Chun Hyang University Hospital Gumi
Gumi
Soon Chun Hyang University Hospital Bucheon
Gyeonggi-do
Soon Chun Hyang University Hospital Seoul
Seoul
About this study
Official title: A Multicenter Clinical Trial to Compare the Efficacy and Safety Between Rosuvastatin/Ezetimibe Combination and Monotherapy of Rosuvastatin in Patients With Diabetes Mellitus and Hypercholesterolemia
A Study to Compare Rosuvastatin/Ezetimibe Combination and Monotherapy in Patients with Diabetes Mellitus and Hypercholesterolemia.
Read the detailed description
This trial is conducted to compare the efficacy and safety between Rosuvastatin/Ezetimibe combination and Rosuvastatin monotherapy in patients with Diabetes Mellitus and Hypercholesterolemia for 8 weeks.
- Being tested
- Rosuvastatin+Ezetimibe, Rosuvastatin
- Medical subject headings
- Diabetes Mellitus, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin+EzetimibeDrug
Also called Rosuvamibe ® 10/5mg
Rosuvastatin 5mg+Ezetimibe 10mg
RosuvastatinDrug
Also called Monorova ® 5mg
Rosuvastatin 5Mg Tablet
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin+Ezetimibe | Experimental | Rosuvastatin 5mg+Ezetimibe 10mg Rosuvamibe ® Tablet, 1T, Once a day/8week Receives: Drug: Rosuvastatin+Ezetimibe |
| Rosuvastatin | Active comparator | Rosuvastatin 5mg Monorova ® Tablet, 1T, Once a day/8week Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low density lipoprotein cholesterol (LDL-C) (%)
The rate of change(%) of LDL-C at Week 8 compared to the baseline
Measured: baseline, Week 8
Secondary outcomes (5)
Low density lipoprotein cholesterol (LDL-C) (100mg/dL)
The ratio of patients who reached the treatment target (100mg/dL) of LDL-C at Week 8 compared to the baseline
Measured: baseline, Week 8
HbA1C, Glycated albumin, Homeostasis model assessment Insulin resistance(HOMA-IR), Homeostasis model assessment ß cell(HOMA-ß) resistance(HOMA-IR), Homeostasis model assessment ß cell(HOMA-ß)
Variation of HbA1C, Glycated albumin, Homeostasis model assessment Insulin resistance(HOMA-IR), Homeostasis model assessment ß cell(HOMA-ß) at Week 8 compared to the baseline resistance(HOMA-IR), Homeostasis model assessment ß cell(HOMA-ß) change form the baseline at Week 8
Measured: baseline, Week 8
LDL-C, Non HDL-C, HDL-C, Triglyceride(TG), Total cholesterol(TC), Apolipoprotein A1, Apolipoprotein B, Lipid ratios (LDL-C/HDL-C, TC/HDL-C, Non- HDL-C/HDL-C) Apolipoprotein A1, Apolipoprotein B, Lipid ratios (LDL-C/HDL-C, TC/HDL-C, Non- HDL-C/HDL-C)
Variation of LDL-C, Non HDL-C, HDL-C, Triglyceride(TG), Total cholesterol(TC), Apolipoprotein A1, Apolipoprotein B, Lipid ratios (LDL-C/HDL-C, TC/HDL-C, Non- HDL-C/HDL-C) at Week 8 compared to the baseline Apolipoprotein A1, Apolipoprotein B, Lipid ratios (LDL-C/HDL-C, TC/HDL-C, Non- HDL-C/HDL-C) change form the base line at Week 8
Measured: baseline, Week 8
Thiobarbituric acid reactive substances(TBARs)
Absolute value change of Thiobarbituric acid reactive substances(TBARs) at Week 8 compared to baseline to baseline.
Measured: baseline, Week 8
Fibroblast Growth Factor 21
Absolute value change of Fibroblast Growth Factor 21 at Week 8 compared to baseline.
Measured: baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start10 Aug 2017
- Primary completion3 Apr 2019
- Study completion23 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus and HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Linical Korea
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217409
- Sponsor's protocol ID
- YMC022
- Status last verified
- Sep 2019
- First submitted
- 12 Jul 2017
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Trial to Compare the Efficacy and Safety Between Rosuvastatin/Ezetimibe Combination and Monotherapy of Rosuvastatin in Patients With Diabetes Mellitus and Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT03217409
- Acronym / sponsor ID
- YMC022
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Linical Korea
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 3 Apr 2019 (actual)
- Study completion
- 23 May 2019 (actual)
- First posted
- 14 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Study to Compare Rosuvastatin/Ezetimibe Combination and Monotherapy in Patients with Diabetes Mellitus and Hypercholesterolemia.
Detailed description
This trial is conducted to compare the efficacy and safety between Rosuvastatin/Ezetimibe combination and Rosuvastatin monotherapy in patients with Diabetes Mellitus and Hypercholesterolemia for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin+Ezetimibe | Experimental | Drug: Rosuvastatin+EzetimibeRosuvastatin 5mg+Ezetimibe 10mg Rosuvamibe ® Tablet, 1T, Once a day/8week |
| Rosuvastatin | Active comparator | Drug: RosuvastatinRosuvastatin 5mg Monorova ® Tablet, 1T, Once a day/8week |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects ≥ 19 or ≤ 75 years of age
- Subjects undergoing treatment for type 2 diabetes
- Subjects undergoing treatment of statin for hypercholesterolemia
- Fasting LDL-C ≤ 250mg/dL at the screening visit
- Fasting LDL-C ≥70mg/dL or ≤ 160mg/dL at the randomization visit
Key exclusion criteria (7 listed)
- Subjects with hypersensitivity reaction to Statin and Ezetimibe
- Subjects with severe kidney disease
- Subjects with HIV positive result at the screening
- Pregnant or breast-feeding subjects
- Subjects with taking any medication affecting level of LDL (Fenofibrate, Omega 3 fatty aicd etc.)
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 |
|---|---|---|
| Rosuvastatin+EzetimibeAlso: Rosuvamibe ® 10/5mgRosuvastatin 5mg+Ezetimibe 10mg | Drug | Rosuvastatin+Ezetimibe |
| RosuvastatinAlso: Monorova ® 5mgRosuvastatin 5Mg Tablet | Drug | Rosuvastatin |
Primary outcome
Low density lipoprotein cholesterol (LDL-C) (%)
Time frame: baseline, Week 8
The rate of change(%) of LDL-C at Week 8 compared to the baseline
5 secondary outcomes
Low density lipoprotein cholesterol (LDL-C) (100mg/dL)
Time frame: baseline, Week 8
HbA1C, Glycated albumin, Homeostasis model assessment Insulin resistance(HOMA-IR), Homeostasis model assessment ß cell(HOMA-ß) resistance(HOMA-IR), Homeostasis model assessment ß cell(HOMA-ß)
Time frame: baseline, Week 8
LDL-C, Non HDL-C, HDL-C, Triglyceride(TG), Total cholesterol(TC), Apolipoprotein A1, Apolipoprotein B, Lipid ratios (LDL-C/HDL-C, TC/HDL-C, Non- HDL-C/HDL-C) Apolipoprotein A1, Apolipoprotein B, Lipid ratios (LDL-C/HDL-C, TC/HDL-C, Non- HDL-C/HDL-C)
Time frame: baseline, Week 8
Thiobarbituric acid reactive substances(TBARs)
Time frame: baseline, Week 8
Fibroblast Growth Factor 21
Time frame: baseline, Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin+Ezetimibe and Rosuvastatin in people with Diabetes Mellitus and Hypercholesterolemia, run by Yuhan Corporation at 4 sites in South Korea.
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 6 inclusion and 7 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 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Low density lipoprotein cholesterol (LDL-C) (%) (time frame: baseline, Week 8). 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 23 Sep 2019.