None listed
Conditions
Interventions
Drug : Drug Information: Trulicity 5 mg (Linagliptin) once daily, oral / Actos 15 mg (Pioglitazone hydrochloride) once daily, oral.
The total study duration is approximately 6 months from the enrollm
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Adults aged 20 to 75 years with type 2 diabetes (both male and female). 2)Individuals with a BMI between 20 and 40 at the screening visit. 3)Those who have been on a stable dose of metformin (= 1,000 mg/day, either immediate-release or extended-release) combined with SGLT2 inhibitors* for at least 12 weeks prior to the screening visit (combination therapy with a fixed-dose combination of metformin = 1,000 mg/day + SGLT2i is also allowed). )The types and doses of SGLT2 inhibitors allowed in this study are as follows: Dapagliflozin 10 mg/day Empagliflozin 10 mg/day 4)Individuals with an HbA1c between 7% and 10% at the screening visit. 5)Participants who have received a thorough explanation of the clinical trial, fully understood the details, and voluntarily consented to participate by providing written informed consent.
Exclusion criteria
Exclusion criteria: Patients with type 1 diabetes, gestational diabetes, or secondary diabetes. Individuals who have used TZD, DPP-4 inhibitors, insulin, or GLP-1 receptor agonists within 8 weeks prior to the screening visit. Patients with a history of hypersensitivity to TZD or DPP-4 inhibitors. Patients with moderate or severe renal impairment (eGFR < 45), end-stage renal disease, those on dialysis, or who have received a kidney transplant. Patients with ALT or AST levels exceeding 2.5 times the upper limit of normal at the screening visit. Patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis, or a history of ketoacidosis. Patients with NYHA class III or higher heart failure. Patients with a history of myocardial infarction, unstable angina, coronary artery bypass surgery, or any arrhythmia requiring treatment within 24 weeks prior to the screening visit. Patients with a history of severe hypoglycemia. Patients who have undergone or are scheduled to undergo radiographic procedures involving intra-arterial iodinated contrast media within 48 hours prior to the screening visit. Patients with a history of bladder cancer. Patients with a history of malignant tumors (other than bladder cancer) within 5 years prior to the screening visit, except for those with basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma in situ, or those who have not required treatment for a malignant tumor or have had no recurrence for at least 5 years before Visit 1. Patients undergoing treatment for thyroid dysfunction at the screening visit (however, patients on stable thyroid hormone replacement therapy for at least 6 weeks before the screening visit are eligible). Patients who have received chronic systemic corticosteroid therapy (for more than 14 days) within 8 weeks prior to the screening visit. Pregnant or breastfeeding women. Individuals deemed unsuitable for participation in the clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c change | — |
Secondary
| Measure | Time frame |
|---|---|
| FPG, HbA1c response rate , HOMA-beta, HOMA-IR, QUICKI, Lipid parameter (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglyceride, AST, ALT,r-GT, serum Cr, eGFR, Rescue therapy rate, Weight, Blood pressure, HSI, NAFLD liver fat score | — |
Countries
Korea, Republic of
Contacts
Public ContactWooJe Lee
Asan Medical Center
Outcome results
None listed