Type 2 Diabetes MellitusPhase 4NCT03446261
Rosuvastatin/Ezetimibe vs Rosuvastatin in Korean Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia
A Phase 4 study testing Rosuvamibe® Tab and Monorova® Tab in people with Type 2 Diabetes Mellitus and Hypercholesterolemia, run by Yuhan Corporation at 2 sites in South Korea.
Trial summary
To assess the efficacy and safety of rosuvastatin/ezetimibe combination therapy compared to rosuvastatin monotherapy in Korean patients with type 2 diabetes mellitus and hypercholesterolemia Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Hypercholesterolemia
- What is being tested?
- Rosuvamibe® Tab and Monorova® Tab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 23 Feb 2018to 5 Mar 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 19 to 70 years
- Patient with type 2 diabetes who needs treatment for hypercholesterolemia
- Written informed consent
Who cannot join
- Administration of lipid lowering agents for more than one week within 4 weeks prior to screening visit
- Uncontrollable diabetes with HbA1c ≥ 8.5%
- Fasting LDL-C ≤ 70 mg/dL
- Fasting triglyceride ≥ 400 mg/dL
- Total cholesterol ≥ 300 mg/dL
- History of muscular disease or rhabdomyolysis due to use of statin
Show all 13Show fewer
- Hypersensitive to rosuvastatin or ezetemibe
- Contraindications stated in the SPC of rosuvastatin or rosuvastatin/ezetimibe including the following:
- ① Severe renal disease (estimated GFR(MDRD) < 30mL/min/1.73m2)
- ② ALT, AST > 3x ULN or history of active liver disease
- ③ CPK > 3x ULN
- Administration of other investigational products within 30 days prior to screening visit
- Other than the above who is deemed to be ineligible to participate in the trial by investigator
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Asan Medical Center
Kora-ri
Asan Medical Center
Seoul, 05505
About this study
Official title: A Randomized, Multicenter, Open, Parallel, Phase 4 Study to Compare the Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy vs Rosuvastatin Monotherapy in Korean Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia
To assess the efficacy and safety of rosuvastatin/ezetimibe combination therapy compared to rosuvastatin monotherapy in Korean patients with type 2 diabetes mellitus and hypercholesterolemia
Read the detailed description
This study is to assess the efficacy and safety of Rosuvamibe® (rosuvastatin 5mg/ezetimibe 10mg) vs Monorova® (rosuvastatin 10mg) treated for 8 weeks in Korean patients with type 2 diabetes mellitus and hypercholesterolemia.
- Conditions
- Type 2 Diabetes Mellitus, Hypercholesterolemia
- Being tested
- Rosuvamibe® Tab, Monorova® Tab
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvamibe® TabDrug
Rosuvastatin 5mg/ezetimibe 10mg qd for 8 weeks
Monorova® TabDrug
Rosuvastatin 10mg qd for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Rosuvamibe® Tab | Experimental | Rosuvamibe® Tab (rosuvastatin 5mg/ezetimibe 10mg) qd for 8 weeks Receives: Drug: Rosuvamibe® Tab |
| Monorova® Tab | Active comparator | Monorova® Tab (rosuvastatin 10mg) qd for 8 weeks Receives: Drug: Monorova® Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to week 8 in ApoB/ApoA1 ratio
Measured: Baseline, Week 8
Secondary outcomes (7)
Proportion of over 50% reduction in LDL-C
Measured: Baseline, Week 8
Proportion of subjects achieving the comprehensive lipid target (LDL-C<70mg/dL, Non-HDL-C<100mg/dL, and ApoB<80mg/dL)
Measured: Baseline, Week 8
Change from baseline to week 8 in total, non-HDL, LDL and HDL cholesterol, triglyceride, ApoB, ApoA1 and ApoB48
Measured: Baseline, Week 8
Change from baseline to week 8 in HOMA-IR
Measured: Baseline, Week 8
Change from baseline to week 8 in hs-CRP
Measured: Baseline, Week 8
Change from baseline to week 8 in HbA1C
Measured: Baseline, Week 8
Change from baseline to week 8 in FPG
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 posted26 Feb 2018
- Study start23 Feb 2018
- Primary completion5 Mar 2019
- Study completion5 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446261
- Sponsor's protocol ID
- YMC029
- Status last verified
- Jul 2019
- First submitted
- 20 Feb 2018
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee J, Hwang YC, Lee WJ, Won JC, Song KH, Park CY, Ahn KJ, Park JY. Comparison of the Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy and Rosuvastatin Monotherapy on Lipoprotein in Patients With Type 2 Diabetes: Multicenter Randomized Controlled Study. Diabetes Ther. 2020 Apr;11(4):859-871. doi: 10.1007/s13300-020-00778-1. Epub 2020 Feb 17.
PubMed 32065359
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Open, Parallel, Phase 4 Study to Compare the Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy vs Rosuvastatin Monotherapy in Korean Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT03446261
- Acronym / sponsor ID
- YMC029
- Conditions
- Type 2 Diabetes Mellitus, Hypercholesterolemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 5 Mar 2019 (actual)
- Study completion
- 5 Mar 2019 (actual)
- First posted
- 26 Feb 2018 (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.
To assess the efficacy and safety of rosuvastatin/ezetimibe combination therapy compared to rosuvastatin monotherapy in Korean patients with type 2 diabetes mellitus and hypercholesterolemia
Detailed description
This study is to assess the efficacy and safety of Rosuvamibe® (rosuvastatin 5mg/ezetimibe 10mg) vs Monorova® (rosuvastatin 10mg) treated for 8 weeks in Korean patients with type 2 diabetes mellitus and hypercholesterolemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvamibe® Tab | Experimental | Drug: Rosuvamibe® TabRosuvamibe® Tab (rosuvastatin 5mg/ezetimibe 10mg) qd for 8 weeks |
| Monorova® Tab | Active comparator | Drug: Monorova® TabMonorova® Tab (rosuvastatin 10mg) qd for 8 weeks |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 19 to 70 years
- Patient with type 2 diabetes who needs treatment for hypercholesterolemia
- Written informed consent
Key exclusion criteria (13 listed)
- Administration of lipid lowering agents for more than one week within 4 weeks prior to screening visit
- Uncontrollable diabetes with HbA1c ≥ 8.5%
- Fasting LDL-C ≤ 70 mg/dL
- Fasting triglyceride ≥ 400 mg/dL
- Total cholesterol ≥ 300 mg/dL
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 |
|---|---|---|
| Rosuvamibe® TabRosuvastatin 5mg/ezetimibe 10mg qd for 8 weeks | Drug | Rosuvamibe® Tab |
| Monorova® TabRosuvastatin 10mg qd for 8 weeks | Drug | Monorova® Tab |
Primary outcome
Change from baseline to week 8 in ApoB/ApoA1 ratio
Time frame: Baseline, Week 8
7 secondary outcomes
Proportion of over 50% reduction in LDL-C
Time frame: Baseline, Week 8
Proportion of subjects achieving the comprehensive lipid target (LDL-C<70mg/dL, Non-HDL-C<100mg/dL, and ApoB<80mg/dL)
Time frame: Baseline, Week 8
Change from baseline to week 8 in total, non-HDL, LDL and HDL cholesterol, triglyceride, ApoB, ApoA1 and ApoB48
Time frame: Baseline, Week 8
Change from baseline to week 8 in HOMA-IR
Time frame: Baseline, Week 8
Change from baseline to week 8 in hs-CRP
Time frame: Baseline, Week 8
Change from baseline to week 8 in HbA1C
Time frame: Baseline, Week 8
Change from baseline to week 8 in FPG
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 Jul 2019.
- Derived from this study: PubMed 32065359Lee J, Hwang YC, Lee WJ, Won JC, Song KH, Park CY, Ahn KJ, Park JY. Comparison of the Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy and Rosuvastatin Monotherapy on Lipoprotein in Patients With Type 2 Diabetes: Multicenter Randomized Controlled Study. Diabetes Ther. 2020 Apr;11(4):859-871. doi: 10.1007/s13300-020-00778-1. Epub 2020 Feb 17.
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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.
2 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 Rosuvamibe® Tab and Monorova® Tab in people with Type 2 Diabetes Mellitus and Hypercholesterolemia, run by Yuhan Corporation at 2 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 3 inclusion and 13 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 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Change from baseline to week 8 in ApoB/ApoA1 ratio (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?
On the ClinicalTrials.gov record for NCT03446261, which also lists 1 linked publication.
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 Jul 2019.