None listed
Conditions
Interventions
Drug : Randomly assigned 1:1 at the time of registration
1) Addition of oral 10 mg/tablet of Jardiance daily to existing oral medications (sulfonylurea, metformin, DPP4 inhibitor)
2) (Among existing o
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Men or women aged 19 to 75 years old ? Treated with sufficient dose of Metformin (1000 mg/day or more), Sulfonylurea (Glimepiride 4 mg/day or more or Gliclazide 60 mg/day or more), and DPP-4 inhibitor (taken as a daily fixed dose) combination for 12 weeks or more ? Patients with relatively poor blood sugar control with HbA1c = 7.5% at the time of screening ? BMI = 18.5 kg/m2 ? Patients who were recommended for insulin treatment by their doctor, but refused ? Those who understand the contents of the clinical trial, are cooperative with the trial, and are judged to be able to participate until the end of the clinical trial ? A person who voluntarily agreed ton informed consent form to participate in the clinical trial after hearing the explanation of this clinical trial
Exclusion criteria
Exclusion criteria: ? Diabetes patients other than type 2 diabetes, including type 1 diabetes and gestational diabetes ? Patients with hypersensitivity reaction to the main ingredients and components of this drug ? Persons with a history of discontinuing GLP-1 receptor agonists or SGLT-2 inhibitory drugs due to serious side effects prior to the screening visit ? Those with acute or chronic metabolic acidosis including diabetic ketoacidosis, or ketosis for any cause within 12 weeks of screening ? Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsoption. ? Patients receiving chronic oral or parenteral steroid treatment within 8 weeks before screening test (more than 14 consecutive days) ? People with severe renal disease: eGRF (CKD-EPI) <45 ml/min/1.73 m2 *eGFR (CKD-EPI) = 141 x min (creatinine/k, 1)a x max (creatinine/k, 1) -1.209 x 0.993Age x 1.018 (if female) ? If there is hematuria on the naked eye that has not been tested ? Patients with severe liver disease or when AST/ALT has risen more than three times the upper limit of normal ? Those who have been diagnosed with a malignant tumor within the last 5 years and have not completed treatment (but carcinoma in situ is allowed), provided that patients with properly controlled basal cell carcinoma, squamous cell skin cancer, cervical epithelial cancer, or thyroid cancer can participate. ? Those who have been hospitalized for uncontrolled arrhythmia, unstable angina, myocardial infarction, stroke, cerebrovascular disease within 24 weeks of screening ? Those who have serious infections or trauma, or are scheduled for surgery within 6 months ? Organ transplant recipients or those who need to administer long-term immunosuppressants ? Those who plan to become pregnant during the clinical trial or do not agree to appropriate contraception ? Pregnant or lactating women ? Any other investigator who determines that participation in the clinical trial is not appropriate ? Those who participated in other clinical trials within 60 days of screening (excluding observational studies)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in HbA1c from basline over 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in fasing plasma glucose from basline over 24 weeks;Changes in fasing insulin, HOMA-IR, and HOMA beta from basline over 24 weeks;frequency of hypoglycemic events over 24 weeks;Changes in body weight from basline over 24 weeks;Changes in cardio-metabolic markers from basline over 24 weeks;Drug compliance;Safety assessment | — |
Countries
Korea, Republic of
Contacts
Public ContactEun Young Lee
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed