None listed
Conditions
Interventions
Drug : Stabilization Period: Sitagliptin 100mg/day+metformin 1000mg/day or more
Run-in Period: Sitagliptin 100mg/day+metformin 1000mg/day or more+placebo of DLT2341(empagliflozin 10mg)/day+placebo of
Sponsors
Dalim BioTech
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Adults between 19 and 85 years of age at the time of written consent. 2. Patients with type 2 diabetes who have been taking oral antidiabetic drugs for at least 8 weeks prior to screening. 3. Patients whose glycosylated hemoglobin (HbA1c) levels at the time of screening meet one of the following criteria based on central lab results: - For patients on monotherapy or dual therapy with oral antidiabetic drugs: 7% = HbA1c = 10.5% - For patients on triple therapy with oral antidiabetic drugs: 6.5% = HbA1c = 9.5% 4. Males and females of childbearing potential who agree to use medically acceptable contraception* during the clinical trial. *Medically acceptable contraceptive methods include: hormonal contraception (oral contraceptives are permitted for female subjects as long as the dose remains unchanged throughout the trial), intrauterine devices (IUD or IUS), tubal ligation, dual barrier methods (e.g., cervical cap or diaphragm used with a male condom), or a single barrier method used with a spermicide. 5. Females of childbearing potential with a negative pregnancy test prior to administration of the investigational product. 6. Body Mass Index (BMI) = 40 kg/m2 at screening. 7. Individuals who have voluntarily decided to participate and provided written consent after hearing and understanding the detailed explanation of the clinical trial. Criteria at the Time of Visit 2 (Randomization) before entering the Treatment Period 8. Central laboratory test results at Visit 1-1 show 7% = HbA1c = 10.5%. 9. Patients who have consistently taken at least 1,000 mg/day of metformin and the investigational product during the run-in period without any changes in dose or regimen. 10. Patients with a drug compliance rate of 70% or higher during the run-in period.
Exclusion criteria
Exclusion criteria: 1. Patients with type 1 or secondary diabetes. 2. History of lactic acidosis, diabetic ketoacidosis, acute or chronic metabolic acidosis including ketoacidosis, or diabetic coma/precoma. 3. Presence of severe diabetic complications, such as diabetic retinopathy. 4. History of hypersensitivity to any component of the investigational product, or to biguanides, DPP-4 inhibitors, or SGLT-2 inhibitors. 5. Genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. 6. Received insulin therapy for more than 7 consecutive or non-consecutive days within 12 weeks prior to screening. 7. History of SGLT-2 inhibitor use within 8 weeks prior to screening. 8. Fasting plasma glucose (FPG) > 270 mg/dL based on central lab results at screening. 9. Triglyceride (TG) = 500 mg/dL based on central lab results at screening. 10. Any of the following conditions related to liver function: * ALT or AST levels > 3 times the upper limit of normal based on central lab results at screening. * Total bilirubin > 2 times the upper limit of normal based on central lab results at screening. * Jaundice. * Significant abnormal liver function as determined by the investigator. 11. Any of the following conditions related to renal function: * Acute conditions that may affect renal function, such as sepsis. * Estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73m2 as measured by CKD-EPI, based on central lab results at screening. * End-Stage Renal Disease (ESRD) or currently undergoing hemodialysis. 12. History of cerebral infarction, cerebral hemorrhage, stroke, transient ischemic attack, acute myocardial infarction, cardiovascular collapse (shock), acute coronary syndrome, acute and unstable heart failure, or unstable angina within 12 weeks prior to screening. 13. Uncontrolled severe hypertension (systolic blood pressure = 180 mmHg or diastolic blood pressure = 110 mmHg). 14. History of a malignant tumor diagnosis within 5 years prior to screening. (However, patients diagnosed with basal cell carcinoma, squamous cell carcinoma, cervical intraepithelial neoplasia, or thyroid cancer who have been deemed cured within 5 years of screening, have not received treatment for the disease, or are considered to have no risk of recurrence may be included). 15. Patients with severe urinary tract infections, including sepsis and pyelonephritis. 16. Patients with severe infections or severe traumatic systemic disorders. 17. Patients being treated for malnutrition, starvation, wasting, pituitary insufficiency, or adrenal insufficiency. 18. Pulmonary infarction, severe pulmonary dysfunction, or other conditions with a risk of hypoxemia. 19. Patients with gastrointestinal disorders such as dehydration, diarrhea, or vomiting. 20. Patients with acute pancreatitis, including hemorrhagic or necrotic pancreatitis. 21. History of drug abuse or alcoholism within 12 weeks prior to screening. 22. Thyroid dysfunction requiring or currently receiving medication, with a Thyroid Stimulating Hormone (TSH) level outside the normal range based on central lab results at screening. (However, patients who have been on a stable dose of thyroid hormone for at least 4 weeks prior to screening may be included at the investigator's discretion). 23. Received systemic corticosteroids for more than 7 consecutive days within 4 weeks prior to screening. 24. History of taking weight-loss medication within 12 weeks prior to screeni
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c (%) from baseline;Adverse Events, Frequency of Hypoglycemia, Clinical Laboratory Tests(Hematological and Blood Chemical Tests, Urine tests), Vital Signs, Physical Examination, ECG Tests | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in HbA1c (%) from baseline at week 12. 2. Change in Fasting Plasma Glucose (FPG) from baseline at weeks 12 and 24. 3. Proportion of subjects who reached an HbA1c < 6.5% at week 24. 4. Proportion of subjects who reached an HbA1c < 7.0% at week 24. 5. Change in Glycemic parameters (Insulin, C-peptide, HOMA-IR, HOMA-ß, QUICKI) from baseline at weeks 12 and 24. 6. Change in Lipid parameters (Triglyceride, Total Cholesterol, LDL-C, HDL-C, non-HDL-C, Apo A1, Apo B, Apo B/ApoA1 ratio) from baseline at weeks 12 and 24. 7. Change in body weight and waist circumference from baseline at weeks 12 and 24. 8. Change in eGFR and UACR from baseline at weeks 12 and 24. 9. Proportion of subjects who took rescue medication during the treatment period. 10. Change in blood pressure from baseline at weeks 12 and 24. 11. Change in HbA1c (%) from baseline and week 24 at weeks 38 and 52. 12. Change in FPG from baseline and week 24 at weeks 38 and 52. 13. Proportion of subjects who reached an HbA1c < 6.5% at week 52. 14. Proportion of subjects who reached an HbA1c < 7.0% at week 52. 15. Proportion of subjects who took rescue medication during the extension study. | — |
Countries
Korea, Republic of
Contacts
Public ContactJungmin Jo
The Catholic University of Korea, Yeouido St. Mary's Hospital
Outcome results
None listed