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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02586129
Other study ID # YH14755-301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 4, 2015
Est. completion date July 7, 2017

Study information

Verified date October 2018
Source Yuhan Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 249
Est. completion date July 7, 2017
Est. primary completion date July 7, 2017
Accepts healthy volunteers No
Gender All
Age group 19 Years to 75 Years
Eligibility 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:

- 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

Study Design


Intervention

Drug:
YH14755
20/1500mg, QD
Metformin
1500mg, QD
Rosuvastatin
20mg, QD

Locations

Country Name City State
Korea, Republic of Seoul National Universitiy Bundang Hospital Seongnam-Si Gyeonggi-Do

Sponsors (1)

Lead Sponsor Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in LDL Cholesterol Change from baseline at 16 weeks
Primary Change in HbA1c Change from baseline at 16 weeks
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