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

NCT02586129 | Completed Phase 3

• 1 other identifier: YH14755-301
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyslipidemia; Type II Diabetes

Outcome Measures

Primary Outcomes (2)

• Change in LDL Cholesterol

  Change from baseline at 16 weeks

• Change in HbA1c

  Change from baseline at 16 weeks

Study Arms (3)

YH14755

EXPERIMENTAL

PO, Once Daily, 16 weeks

Drug: YH14755

Metformin

ACTIVE COMPARATOR

PO, Once Daily, 16 weeks

Drug: Metformin

Rosuvastatin

ACTIVE COMPARATOR

PO, Once Daily, 16 weeks

Drug: Rosuvastatin

Interventions

YH14755 DRUG

20/1500mg, QD

YH14755

Metformin DRUG

1500mg, QD

Metformin

Rosuvastatin DRUG

20mg, QD

Rosuvastatin

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent
• Subjects with Dyslipidemia and Type II Diabetes
• % ≤ 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.
• years later, men and women under the age of 75

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (1)

Seoul National Universitiy Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Dyslipidemias; Diabetes Mellitus, Type 2

Interventions

Metformin; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hakcheol Jang, M.D., Ph.D.

  Department of Internal Medicine, SNU Bundang Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: October 26, 2015
• Study Start: November 4, 2015
• Primary Completion: July 7, 2017
• Study Completion: July 7, 2017
• Last Updated: October 3, 2018

Record last verified: 2018-10

Locations

KR (1)