Dyslipidemia, Type II Diabetes
Conditions
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.
Interventions
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in LDL Cholesterol | Change from baseline at 16 weeks |
| Change in HbA1c | Change from baseline at 16 weeks |
Countries
South Korea
Outcome results
None listed