None listed
Conditions
Interventions
Drug : For intervention group, oral combination pill of SGLT-2 inhibitor (Empagliflozin 25mg) and TZD(Loebeglitazone 0.5mg) {CKD-398[Empagliflozin 25mg+Lobeglitazone 0.5mg} per day for at least 28 wee
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female aged 19-75 years diagnosed with T2D 2) T2D on stable daily 2 drugs doses for 12 weeks prior to the day of screening: metformin (=1000 mg/day), DPP4 inhibitors (availiable drugs in Korea) 3) HbA1c of 7.1-8.5% at the time of screening 4) BMI = 18.5 kg/m2 5) T2D who understand the protocol and fully cooperate the clinical trial until the end of the study 6) T2D who are vuluntarily capable of giving signed informed consent
Exclusion criteria
Exclusion criteria: 1) Have type 1 diabetes mellitus, gestational diabetes or other type of diabetes except type 2 diabetes 2) Have any other condition (eg, hypersensitivity) that is a contraindication to TZD or SGLT2 inhibitor main incredient 3) Have a history of taking any kind of TZD or SGLT2 inhibitor inhibitor prior to screening time within 3 months or severe side effects of TZD or SGLT2 inhibitor 4) Have uncontrolled diabetes requiring immediate therapy (such as coma, acute or chronic diabetic ketoacidosis) at screening or randomization within 12 weeks, in the judgment of the physician 5) Have history of diabetic coma or pre-coma state 6) Have a history of genetic disease such as galactose intolerance, Lapp lactase deficiency or glucose-galactose mal-absorption 7) Have a history of steroid (oral or non-oral route) prior to screening time for more than 14 days consecutively within 8 weeks; except for inhaltor 8) Have known chronic renal failure (stage 2,defined as a known CKD-EPI eGFR <60 mL/minute/1.73 m2) 9) Visible gross hematuria 10) Have acute hepatitis, signs or symptoms of any other liver disease, or an alanine aminotransferase (ALT), AST, ASL, bilirubin level =2.5X the upper limit of normal (ULN), or Child-Pugh class B or C for the reference range, 11) Have a history of an active or untreated malignancy (but carcinoma in situ is allowed) or are in remission from a clinically significant malignancy for less than 5 years prior to screening time, but controlled basal or squamous skin cancer, cervical intraneoplasm and thyroid cancer are allowed. 12) Have had an MI, surgical or percutaneous coronary revascularization procedure, ischemic stroke, carotid stenting or surgical revascularization, nontraumatic amputation or peripheral vascular procedure (eg, stenting or surgical revascularization) less than 12 weeks prior to screening 12) Those who satarted to take on stain within 4 weeks at the time of screening or are expected to increase the doses of statin during clinical trial 13) Have chronic New York Heart Association Functional Classification III or IV CHF 14) Have transplantation or treated with immunosuppressive drugs 15) Woman of planning pregnancy or refusing contraception 16) Women of childbearing or lactation 17) not suitable patients judged by physician 18) Those who are severe infection, traumatized 19) Have a history of any other condition (such as known drug or alcohol abuse or psychiatric disorder) 20) Have participated within the last 30 days in a clinical trial involving an investigational product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c difference between baseline and end-of study within 112 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Durability periods, Cardiometabolic markers change, safety, fatty liver markers change, what the investigators demand | — |
Countries
Korea, Republic of
Contacts
Public ContactByung-Wan Lee
Yonsei University
Outcome results
None listed