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

• Status: Completed
• Trial end date: 2017-07-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yuhan Corporation
• Treatments: Metformin; Rosuvastatin Calcium

Criteria

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