to Evaluate the Safety and Efficacy of Pitavastatin in Patients With IFG and Hyperlipidemia
NCT02056847 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 313
Last updated 2018-03-08
Summary
Primary Objective
: To evaluate that there is no different effect on HbA1c between routine lipid lowering therapy(Livalo 2mg) and intensive lipid lowering therapy(Livalo 4mg) in the hyperlipidemic patients with impaired fasting glucose (IFG).
H0: µT-µC ≥ 0.4 vs H1: µT-µC \< 0.4
µT = the change of HbA1c in the test drug (Pitavastatin 4 MG) µC = the change of HbA1c in the control drug (Pitavastatin 2 MG)
Conditions
- HbA1c Level Associated With Lipid Compositions
Interventions
- DRUG
-
Pitavastatin calcium 4mg
taking once a day
- DRUG
-
Pitavastatin calcium 2mg
Taking once a day
Sponsors & Collaborators
-
The Catholic University of Korea
collaborator OTHER -
Kyunghee University Medical Center
collaborator OTHER -
Korea University Guro Hospital
collaborator OTHER -
Dong-A University Hospital
collaborator OTHER -
Seoul National University Bundang Hospital
collaborator OTHER -
Samsung Medical Center
collaborator OTHER -
Seoul National University Hospital
collaborator OTHER -
Ajou University School of Medicine
collaborator OTHER -
Gangnam Severance Hospital
collaborator OTHER -
Severance Hospital
collaborator OTHER -
Yeungnam University Hospital
collaborator OTHER -
Ulsan University Hospital
collaborator OTHER -
Eulji University Hospital
collaborator OTHER -
Asan Medical Center
collaborator OTHER -
Chonnam National University Hospital
collaborator OTHER -
Chonbuk National University Hospital
collaborator OTHER -
Chungnam National University Hospital
collaborator OTHER -
Hallym University Medical Center
collaborator OTHER - lead INDUSTRY
Principal Investigators
-
NamSik Chung, M.D., Ph D. · Severance Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-09-30
- Primary Completion
- 2017-05-31
- Completion
- 2017-05-31
Countries
- South Korea
Study Locations
More Related Trials
-
Placebo and Active Comparator Controlled Dose Response Study of Rivoglitazone in Type 2 Diabetes
NCT00575874 ·Status: COMPLETED ·Phase: PHASE2
-
Low-Dose Pioglitazone in Patients With NASH (AIM 2)
NCT04501406 ·Status: RECRUITING ·Phase: PHASE2
-
Efficacy and Safety Study of Pioglitazone Combined With Metformin on Metabolic Syndrome in Subjects With Type 2 Diabetes
NCT00772174 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of DPP-IV Inhibitor in Patients With Type 2 Diabetes
NCT00111631 ·Status: COMPLETED ·Phase: PHASE2
-
Placebo Controlled Dose-Response Study of Rivoglitazone in Type 2 Diabetes
NCT00575471 ·Status: COMPLETED ·Phase: PHASE2
-
Pioglitazone and Serum Asymmetric Dimethylarginine (ADMA) in Patients With Diabetes
NCT00770367 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Evaluate the Efficacy and Safety of Pioglitazone 15mg or 30mg Add-on in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin
NCT04885712 ·Status: COMPLETED ·Phase: PHASE3
-
The Practical Evidence of Antidiabetic Combination Therapy in Korea
NCT02231021 ·Status: COMPLETED ·Phase: PHASE4
-
Effects of Ipragliflozin on Excessive Fat in Type 2 Diabetes Patients With Non-alcoholic Fatty Liver Disease Treated With Metformin and Pioglitazone
NCT02875821 ·Status: COMPLETED ·Phase: PHASE4
-
Metabolic Effects of Pioglitazone in Type II Diabetic Patients Previously Treated With Insulin
NCT00576784 ·Status: COMPLETED ·Phase: PHASE4
-
Observational Study to Assess Glycosylated Hemoglobin Changes After 6 Months of Treatment With Pioglitazone.
NCT00449553 ·Status: COMPLETED
-
Glibenclamide (Dose to be Titrated From Starting Dose of 5mg om) Plus Rosiglitazone 4mg om (Increased to 8mg om After 6 Months) and vs Glibenclamide (Dose to be Titrated With Starting Dose of 5mg om) Plus Placebo, Administered to Patients With Type 2 Diabetes Mellitus
NCT01045590 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety of Evoglitin in Patients With Type 2 Diabetes and Non-alcoholic Fatty Liver Diseases
NCT03910361 ·Status: COMPLETED ·Phase: PHASE4
-
Study to Compare Pioglitazone and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus and Dyslipidemia
NCT00331487 ·Status: COMPLETED ·Phase: PHASE3
-
Drug-drug Interaction Study(Lobeglitazone, Warfarin)
NCT02002611 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of CKD-501 Versus Pioglitazone When Added to Metformin
NCT01106131 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Pioglitazone on Cardiovascular Outcome on Higashi-Saitama Trial in Patients With Type 2 Diabetes
NCT00419484 ·Status: COMPLETED
-
Study to Assess the Effects of Daily Administration of Pioglitazone on Brain Hemodynamics in Healthy Elderly Participants
NCT01456117 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Dipeptidyl-peptidase IV (DPP-IV) RO4876904 in Patients With Type 2 Diabetes.
NCT00502710 ·Status: COMPLETED ·Phase: PHASE2
-
Clinical Trial of YH14755 in Subjects With Dyslipidemia and Type II Diabetes
NCT02586129 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Identify the Risk of Non-alcoholic Fatty Liver Disease (NAFLD) in Patients With Type 2 Diabetes in Clinical Practice and to Evaluate the Clinical Usefulness of Dapagliflozin/Pioglitazone Combination Therapy
NCT06649162 ·Status: RECRUITING
-
Phase 3 Trial to Evaluate the Efficacy and Safety of LC15-0444 in Patients With Type 2 Diabetes
NCT01601990 ·Status: COMPLETED ·Phase: PHASE3
-
Antidiabetic Drugs for Steatotic Liver Disease
NCT03646292 ·Status: COMPLETED ·Phase: PHASE4
-
Effects of Insulin Sensitizers in Subjects With Impaired Glucose Tolerance
NCT00108615 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety of Chiglitazar Added to Glargine in Patients With Type 2 Diabetes
NCT06007014 ·Status: NOT_YET_RECRUITING ·Phase: NA