None listed
Conditions
Interventions
Drug : 1) TZD (Pioglitazone 15mg, Acpio®) : once daily, regardless of meal time, for 24 weeks 2) SGLT-2 inhibitor (Empagliflozin 10mg, Jardiance®) : once daily, regardless of m
will be prescribed increased dosage of Pioglitazone (in TZD group) or Empagliflozin (in SGLT-2 inhibitor group) : from 15mg to 30mg (pioglitazone) or 10mg to 25mg (empagliflozin).
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 19 = age = 80, male or female 2. Type 2 diabetes patients who have taken triple combination therapy of OADs as followed : Metformin (=1000 mg/day), Sulfonylurea (Glimepiride = 4 mg/day or Gliclazide = 60 mg/day), DPP-4 inhibitor (Full dose) for over 12 weeks 3. At screening, 7% < HbA1c = 10% 4. Patients who refused insulin therapy. 5. Subjects who understood the contents of the clinical trial and are cooperative in the trial progress, and are considered to be able to participate until the end of the trial. 6. Patients who have voluntarily agreed in writing to participate in the clinical trial after hearing the explanation of the trial.
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes, gestational diabetes, and other types of diabetes than type 2 diabetes mellitus. 2. Patients who have the history of allergy of hypersensitivity for the medication of the clinical trial. 3. Patients who have the history of taking TZDs or SGLT-2 inhibitors within a year prior to screening visit, or have the history of discontinuation of them due to severe side effects. 4. Patients who have the history of acute or chronic metabolic acidosis including diabetic ketoacidosis (with or without coma), or any kinds of ketosis within 12 weeks prior to screening visit. 5. Patients who have genetic metabolic diseases, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsoption 6. Patients who have the history of taking steroids for more than 2 weeks, within 8 weeks prior to screening visit. 7. Patients who have the history of malignancy within 5 years prior to screening visit (In case of bladder cancer, subjects will be excluded regardless of the time of diagnosis) 8. Patients who have the history of coronary artery bypass surgery or percutaneous coronary intervention, or suffered from heart failure (NYHA class III, IV) 9. Patients who have the history of uncontrolled arrhythmia, unstable angina, myocardial infarction, stroke, transient ischemic attacts, and cerebral vascular disease within 24 weeks prior to the screening date. 10. Patients of chronic renal failure, chronic kidney disease stage 3~5 (estimated glomerular filtration rate calculated vial CKD-EPI <60 mL/min/1.73m2) or on dialysis therapy. 11. Elevated liver enzymes (AST, ALT, ALP = 2.5*upper limit of normal (ULN) or Total bilirubin = 2.5*ULN) or Child-Pugh class B or C (for the patients of liver cirrhosis) 12. Subjects who are pregnant or lactating 13. Perioperative patients, patients with severe infections or severe trauma 14. Patients with unexamined gross hematuria 15. Any other subjects who is determined to be ineligible for the clinical trials by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean difference of HbA1c after 24 week-treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients who achieve target HbA1c level (%);Mean difference of blood glucose after 24 week-treatment;Parameters associated with safety (incidence of adverse events, change of renal function and liver function) | — |
Countries
Korea, Republic of
Contacts
Public ContactJaehyun Bae
Yonsei University
Outcome results
None listed