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

Phase 3

Completed

• Conditions: Dyslipidemia; Type II Diabetes
• Interventions: Drug: YH14755; Drug: Metformin; Drug: Rosuvastatin

• Registration Number: NCT02586129
• Lead Sponsor: Yuhan Corporation

Brief 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.

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 Timeline

• Study First Submitted: 2015-09-22
• Study First Submitted QC: 2015-10-23
• Study First Posted: 2015-10-26
• Study Start: 2015-11-04
• Primary Completion: 2017-07-07
• Study Completion: 2017-07-07
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-02
• Last Update Posted: 2018-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 249

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
YH14755	YH14755	PO, Once Daily, 16 weeks
Metformin	Metformin	PO, Once Daily, 16 weeks
Rosuvastatin	Rosuvastatin	PO, Once Daily, 16 weeks

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	Change from baseline at 16 weeks
Change in LDL Cholesterol	Change from baseline at 16 weeks

Trial Locations

Locations (1)

Seoul National Universitiy Bundang Hospital; 🇰🇷 Seongnam-Si, Gyeonggi-Do, Korea, Republic of