DyslipidemiaPhase 3NCT02586129
Clinical Trial of YH14755 in Subjects With Dyslipidemia and Type II Diabetes
A Phase 3 study testing YH14755, Metformin and Rosuvastatin in people with Dyslipidemia and Type II Diabetes, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
Randomized, double-blind, active-controlled, multicenter phase 3 trial to evaluate the safety and efficacy of YH14755 in subjects with dyslipidemia and Type II Diabetes. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Dyslipidemia, Type II Diabetes
- What is being tested?
- YH14755, Metformin and Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Nov 2015to 7 Jul 2017
- Phase
- Phase 3
- 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
- Signed Informed Consent
- Subjects with Dyslipidemia and Type II Diabetes
- 6.5% ≤ HbA1c level ≤ 9.0% and LDL-C level ≤ 250mg/dL(6.5 nmal/L) at screening
- BMI ≤ 45kg/m2
- Subjects who dose not administered diabetes treatment at least 4 weeks prior to screening visit.
- 19 years later, men and women under the age of 75
Who cannot join
- Pregnant women, nursing mothers or subject who does not agree to assigned contraception in the study
- Subject with type I Diabetes
- Subject with hypertension which does not controlled by treatment(have blood pressure > 160/110mmHg)
- Have a known allergy to drugs
- Have administered Cyclosporine
- Have administered Obesity treatment within 12 weeks prior to screening visit
- Participated in any other clinical trials within 30 days prior to the first administration
- Subject who is judged to be ineligible by investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National Universitiy Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Trial to Evaluate the Safety and Efficacy of YH14755 in Subjects With Dyslipidemia and Type II Diabetes
Randomized, double-blind, active-controlled, multicenter phase 3 trial to evaluate the safety and efficacy of YH14755 in subjects with dyslipidemia and Type II Diabetes.
Read the detailed description
This is a phase 3 trial to evaluate the safety and efficacy of YH14755 in subjects with dyslipidemia and Type II Diabetes.
In YH14755 treatment group, 88 subjects will be assigned and the subjects administer YH14755 for 16 weeks.
In Metformin treatment group, 88 subjects will be assigned and the subjects administer Metformin for 16 weeks.
In Rosuvastatin treatment group, 88 subjects will be assigned and the subjects administer Rosuvastatin for 16 weeks.
- Conditions
- Dyslipidemia, Type II Diabetes
- Being tested
- YH14755, Metformin, Rosuvastatin
- Medical subject headings
- Dyslipidemias, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YH14755Drug
20/1500mg, QD
MetforminDrug
1500mg, QD
RosuvastatinDrug
20mg, QD
| Study group | Role | What they receive |
|---|---|---|
| YH14755 | Experimental | PO, Once Daily, 16 weeks Receives: Drug: YH14755 |
| Metformin | Active comparator | PO, Once Daily, 16 weeks Receives: Drug: Metformin |
| Rosuvastatin | Active comparator | PO, Once Daily, 16 weeks Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LDL Cholesterol
Measured: Change from baseline at 16 weeks
Change in HbA1c
Measured: Change from baseline at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study start4 Nov 2015
- Primary completion7 Jul 2017
- Study completion7 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hakcheol Jang, M.D., Ph.D., Study chair, Department of Internal Medicine, SNU Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586129
- Sponsor's protocol ID
- YH14755-301
- Status last verified
- Oct 2018
- First submitted
- 22 Sep 2015
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Trial to Evaluate the Safety and Efficacy of YH14755 in Subjects With Dyslipidemia and Type II Diabetes
- ClinicalTrials.gov ID
- NCT02586129
- Acronym / sponsor ID
- YH14755-301
- Conditions
- Dyslipidemia, Type II Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2015 (actual)
- Primary completion
- 7 Jul 2017 (actual)
- Study completion
- 7 Jul 2017 (actual)
- First posted
- 26 Oct 2015 (estimated)
- 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.
Randomized, double-blind, active-controlled, multicenter phase 3 trial to evaluate the safety and efficacy of YH14755 in subjects with dyslipidemia and Type II Diabetes.
Detailed description
This is a phase 3 trial to evaluate the safety and efficacy of YH14755 in subjects with dyslipidemia and Type II Diabetes.
In YH14755 treatment group, 88 subjects will be assigned and the subjects administer YH14755 for 16 weeks.
In Metformin treatment group, 88 subjects will be assigned and the subjects administer Metformin for 16 weeks.
In Rosuvastatin treatment group, 88 subjects will be assigned and the subjects administer Rosuvastatin for 16 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| YH14755 | Experimental | Drug: YH14755PO, Once Daily, 16 weeks |
| Metformin | Active comparator | Drug: MetforminPO, Once Daily, 16 weeks |
| Rosuvastatin | Active comparator | Drug: RosuvastatinPO, Once Daily, 16 weeks |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed Informed Consent
- Subjects with Dyslipidemia and Type II Diabetes
- 6.5% ≤ HbA1c level ≤ 9.0% and LDL-C level ≤ 250mg/dL(6.5 nmal/L) at screening
- BMI ≤ 45kg/m2
- Subjects who dose not administered diabetes treatment at least 4 weeks prior to screening visit.
Key exclusion criteria (8 listed)
- Pregnant women, nursing mothers or subject who does not agree to assigned contraception in the study
- Subject with type I Diabetes
- Subject with hypertension which does not controlled by treatment(have blood pressure > 160/110mmHg)
- Have a known allergy to drugs
- Have administered Cyclosporine
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 |
|---|---|---|
| YH1475520/1500mg, QD | Drug | YH14755 |
| Metformin1500mg, QD | Drug | Metformin |
| Rosuvastatin20mg, QD | Drug | Rosuvastatin |
Primary outcome
Change in LDL Cholesterol
Time frame: Change from baseline at 16 weeks
Change in HbA1c
Time frame: Change from baseline at 16 weeks
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 3 Oct 2018.
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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.
Hakcheol Jang, M.D., Ph.D. study chair
Department of Internal Medicine, SNU Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing YH14755, Metformin and Rosuvastatin in people with Dyslipidemia and Type II Diabetes, run by Yuhan Corporation at 1 site 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 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 3 Oct 2018. 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 in LDL Cholesterol (time frame: Change from baseline at 16 weeks). The study lists 2 primary outcomes in all. 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 3 Oct 2018; AzTrials last refreshed its copy on 8 Nov 2026.