None listed
Conditions
Interventions
Drug : IP1: Acpio Tab. 15mg (pioglitazone)
IP2: Jardiance Tab. 10mg (empagliflozin)
IP3: Gladm Tab. 2mg (glimepiride)
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with type 2 diabetes between 20 to 75 years of age 2) 20= BMI =40 at the Screening Visit 3) Those who have been taking Metformin 1000 mg/day (immediate-release and hyper-release) + DPP-4 inhibitor* (metformin 1,000 mg/day + DPP4 inhibitor) at the same dose for at least 12 weeks prior to the Screening Visit. * The types and doses of DPP-4 inhibitors allowed for combination therapy in this study are as follows. Sitagliptin 100 mg/day Vildagliptin 100mg/day Saxagliptin 5 mg/day Linagliptin 5 mg/day Gemigliptin 50 mg/day Teneligliptin 20 mg/day Alogliptin 25 mg/day Evogliptin 5 mg/day Anagliptin 200 mg/day 4) 7%= HbA1c =10% at the Screening Visit 5) Those who spontaneously decides to participate in a Clinical Trial after hearing, fully understanding the detailed explanation of the Clinical Trial and consents in Writing
Exclusion criteria
Exclusion criteria: 1) Patients with type 1 diabetes, gestational diabetes, or secondary diabetes 2) Patients who have used SU, TZD, SGLT2i, insulin, and GLP-1 acceptor agonists within 8 weeks of screening visit 3) Patients with a history of hypersensitivity reactions to metformin, glimepiride, TZD, SGLT2i, DPP-4inhibitors, which are Investigational Products. 4) Patients with moderate or severe renal impairment (eGFR <60), end stage renal disease, or under dialysis 5) In case of ALT or AST at screening visit exceeds 2.5 times the normal upper limit 6) Patients with acute or chronic metabolic acidity including diabetic ketoacidosis and patients with a history of ketoacidosis 7) Patients with heart failure above NYHA class III 8) Patients with arrhythmia who have a history of myocardial infarction, unstable angina, and coronary artery bypass within 24 weeks of screening visit or need treatment 9) Patients with a history of severe hypoglycemia 10) Patients who have been tested to administer radiiodic contrast substances into blood vessels within 48 hours or scheduled during clinical trials based on the time of the screening visit 11) Patients with a history of malignant tumors within 5 years prior to the screening visit (except those diagnosed with underlying cell cancer, squamous cell cancer, or intraepithelial cancer in the cervix, or those who have never been treated or have no possibility of recurrence for at least 5 years prior to visit 1) 12) Patients who are receiving treatment for thyroid dysfunction at the Screening Visit (However, among patients undergoing thyroid hormone replacement therapy, those who have maintained a stable dose for more than 6 weeks before the screening visit can participate) 13) Patients who have chronically administered systemic corticosteroid within 8 weeks (over 14 days) as of the time of the screening visit. 14) Pregnant or lactating women 15) Patients who are judged to be inappropriate to participate in a clinical trial based on the Investigator judgement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| FPG, HbA1c response rate, Weight increase/loss and/or Rate of reaching target HbA1c without hypoglycemia, HOMA-beta, HOMA-IR, Lipid parameter (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglyceride), AST, ALT, r-GT, serum Cr, eGFR, urine albumin/creatinine ratio, Rescue therapy rate, Weight, Blood pressure | — |
Countries
Korea, Republic of
Contacts
Public ContactWoo Je Lee
Asan Medical Center
Outcome results
None listed