None listed
Conditions
Interventions
Drug : This study is intended for patients who received stable co-administration of metformin (MET) and empagliflozin 10 mg (EMPA) for at least 12 weeks without change of dose. Subjects meeting the in
Sponsors
Chonnam National University Hospital Hwasun Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult men or women aged between 19 and 79 2. Patients diagnosed with Type 2 diabetes mellitus (Refer to Diagnosis Criteria from 2018 ADA) 3. Patients under stable treatment with Metformin (2000 mg) and empagliflozin (10 mg) for more than 12 weeks, prior to the participation in the study 4. Patients with HbA1c of 7.0% or higher and less than 10. 5 % 5. Patients with BMI of 23 kg/m2 or higher and less than 45 kg/m2 6. Patients who agree to participate in the study and provide voluntary written consent
Exclusion criteria
Exclusion criteria: 1. Patients with known hypersensitivity to Investigational product, or concomitant medication and component, or drugs of the same type (biguanide, thiazolidinediones SGLT2 inhibitor, DPP4 inhibitor) 2. Patients with genetic problems, such as galactose intolerant Lapp lactose deficiency or glucose galactose absorption disorder 3. Patients with Type 1 Diabetes Mellitus or who need insulin supply through an insulin pump 4. Patients with Glomerular filtration rate (eGFR) < 60 mL / min / 1.73m2 (MDRD-GFR), patients with end stage renal disease (ESRD) or patients on dialysis 5. Patients with acute conditions that may affect renal function such as dehydration, severe infections, shock with cardiovascular collapse), patients with acute myocardial infarction, and patients with sepsis 6. Patients with severe heart failure or patients with medical history of NYHA (Heart Failure New York Heart Association) Class 3, 4 condition 7. Patients with acute and unstable hear failure 8. Patients received the test/examination involving intravenous administration of radioactive iodine contrast agents (e.g. intravenous urography, angiography, contrast medium, Computed tomography, etc.) within 48 hours prior to participation in the study, or expecting to receive during the study period 9. Patients with acute or chronic metabolic acidosis including lactic acidosis, diabetic ketoacidosis (DKA) with or without coma, and patients with a history of ketoacidosis 10. Patients with Diabetic pre-coma 11. Patients in pre and/or Post surgery status, patients with severe infection, patients with severe trauma, and patients with severe traumatic systemic disorder 12. Patients with malnutrition, starvation, weakness, pituitary or adrenal insufficiency 13. Patients with hepatic impairment (liver enzyme levels ALT and AST are more than three times the normal upper limit) 14. Patients with acute or chronic diseases that may cause tissue hypoxia (e.g., respiratory failure, acute myocardial infarction, shock) 15. Patients with gastrointestinal disorders such as diarrhea and vomiting 16. Patients with a medical history or treatment of bladder cancer within 5 years prior to screening 17. Patients receiving lobeglitazone or linagliptin within 3 months prior to study drug administration 18. Patients taking or expecting to take drugs for glycemic control except for Investigational Product or drugs that can have a significant effect on glycemic control (e.g. systemic corticosteroids) during the study period. 19. Patients taking or expecting to take obesity therapeutics and weight-controlling agent (Orlistat) during the study period, or patients undergoing aggressive weight control diet. 20. Patients with uncontrolled hypertension (SBP/DBP, 140 90 mmHg or higher) 21. Patients with hyperglycemic hyperosmolar nonketotic syndrome (HHNS) 22. Pregnant or breast-feeding women 23. Women or men of childbearing potential who are planning to become pregnant or do not intend to use appropriate contraceptives during the study period 24. Patients with alcohol abuse or drug dependence 25. Patients who participated in other clinical trials and received the study drug within 3 months prior to the screening visit 26. Other patients deemed inappropriate for participation in clinical trials by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in HbA1c | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent rate of subjects with HbA1c < 7% and with HbA1c < 6.5%;Changes in FPG;Changes in Fasting C-peptide;Changes in Total body weight, waist circumference, body mass index (BMI);Adverse Events | — |
Countries
Korea, Republic of
Contacts
Public Contacthocheol kang
Chonnam National University Hospital Hwasun Hospital
Outcome results
None listed