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

Dyslipidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02586129
• Other study ID #: YH14755-301
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Dyslipidemia
• Dyslipidemias
• Type II Diabetes

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