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CompletedNCT02586129Updated Oct 3, 2018

Clinical Trial of YH14755 in Subjects With Dyslipidemia and Type II Diabetes

A Phase 3 interventional study of YH14755 and Metformin in Dyslipidemia and Type II Diabetes, sponsored by Yuhan Corporation. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-10-03.

Sponsored by Yuhan Corporation · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
249
Allocation
Randomized
Ages
19 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Dyslipidemia
  • Type II Diabetes
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 249 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Yuhan Corporation is the lead sponsor of 107 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
249 participants (actual)

Study arms

  • Experimental
    YH14755

    PO, Once Daily, 16 weeks

    Drug: YH14755

  • Active comparator
    Metformin

    PO, Once Daily, 16 weeks

    Drug: Metformin

  • Active comparator
    Rosuvastatin

    PO, Once Daily, 16 weeks

    Drug: Rosuvastatin

Interventions

  • DrugYH14755

    20/1500mg, QD

  • DrugMetformin

    1500mg, QD

  • DrugRosuvastatin

    20mg, QD

06

What researchers measure

Primary outcomes

  1. Change in LDL Cholesterol

    Time frame: Change from baseline at 16 weeks

  2. Change in HbA1c

    Time frame: Change from baseline at 16 weeks

07

Study locations

1 site
  • Seoul National Universitiy Bundang Hospital
    Seongnam-Si, Gyeonggi-Do 463-707, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02586129
Lead sponsor
Yuhan Corporation
Responsible party
Sponsor
First posted
Oct 26, 2015
Start date
Nov 4, 2015
Primary completion
Jul 7, 2017
Completion
Jul 7, 2017
Last update
Oct 3, 2018

Study contacts

Hakcheol Jang, M.D., Ph.D.
study chair · Department of Internal Medicine, SNU Bundang Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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