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

Yuhan

Status and phase: Completed; Phase 3

Conditions: Type II Diabetes; Dyslipidemia

Treatments: Drug: YH14755; Drug: Metformin; Drug: Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02586129

YH14755-301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 249 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

249 participants in 3 patient groups

YH14755

Experimental group

Description:

PO, Once Daily, 16 weeks

Treatment:

Drug: YH14755

Metformin

Active Comparator group

Description:

PO, Once Daily, 16 weeks

Treatment:

Drug: Metformin

Rosuvastatin

Active Comparator group

Description:

PO, Once Daily, 16 weeks

Treatment:

Drug: Rosuvastatin