None listed
Conditions
Interventions
Drug : Test group: 50mg of gemigliptin, 100mg of citagliptin, 10mg of dapagliflozin, 0.5mg of lobeglitazone once a day
Control group: Metformin 500mg/day dose increase group (less than 2,000mg/day inc
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Men or women aged 19 to less than 75 years old ? Type 2 diabetes patients who have received sufficient doses of Metformin (over 500 mg/day), DPP4 inhibitor (a commercially available product in Korea, taken in a daily dose), SGLT-2 inhibitor (a commercially available product in Korea, taken in a daily dose), thiazolidinedione (TZD (a commercially available product in Korea, taken in a daily dose) for more than 12 weeks ? Patients with poor glycemic control with 7.0% = HbA1c = 9% at the time of screening ? BMI = 18.5 kg/m2 ? a patient who has been advised to treat insulin by his doctor but has refused to do so ? A person who understands the contents of the clinical trial, is cooperative in the progress of the trial, and is deemed to be able to participate by the end of the clinical trial ? A person who voluntarily agrees in writing to participate in the clinical trial after hearing the description of this clinical trial
Exclusion criteria
Exclusion criteria: ? Diabetes patients other than type 2 diabetes, including type 1 diabetes and gestational diabetes ? Patients who have hypersensitivity to the main ingredients and components of clinical trial drugs (Gemiglo, Dafaene, Posiga, Duvier, Zanubia) ? Patients who have been prescribed insulin within 6 months from the time of screening and administered for more than 12 weeks (no need to be continuous) ? Those who have acute or chronic metabolic acidosis, including diabetic ketoacidosis, or who have ketoacidosis of any cause within 12 weeks of screening ? A person who has taken four-drug combination therapy, including DPP-4 inhibitor, SGLT-2 inhibitor, and TZD drugs, for more than one month, or who has discontinued metformin due to serious side effects, regardless of the period, within three months prior to the screening visit ? Patients on oral or parenteral steroid treatment with chronic (over 14 consecutive days) within 8 weeks of screening ? Severe renal disease and unexamined gross hematuria: eGFR (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) ? Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsoption ? Severe epilepsy patients or if AST/ALT has risen more than 2.5 times the upper limit of normal ? Those who have been diagnosed with malignancy within the last five years and have not been treated (but carcinoma in situ is allowed), but patients with properly controlled basal cell carcinoma, squamous cell skin cancer, cervical endothelial cancer or thyroid cancer can participate ? Those who have been hospitalized with uncontrolled arrhythmia, unstable angina, myocardial infarction, stroke, cerebrovascular disease, NYHA class III or higher within 24 weeks of screening ? Patients with an individual or family history of thyroid medullary cancer (MTC) or with multiple endocrine adenomas (MEN2) ? A recipient of organ transplant or a person who is required to administer a long-term immunosuppressant ? A person who plans to become pregnant during the clinical trial or disagrees with the appropriate contraception ? a pregnant or lactating woman ? Other persons who are deemed inappropriate by the tester to participate in the clinical trial ? Those who participated as subjects of other clinical trials within 30 days of screening (excluding observational studies)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This is the difference in HbA1c change after 24 weeks compared to baseline between the test group treated with the test drug (SGLT2 inhibitor, DPP4 inhibitor, TZD) and the control group increased by 500 mg of metformin. | — |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c change after 24 weeks compared to baseline of test drug (SGLT2 inhibitor, DPP4 inhibitor, TZD);Percentage of patients reaching HbA1c 6.5% and 7.0% after 24 weeks of trial drug (SGLT2 inhibitor, DPP4 inhibitor, TZD);Blood sugar, glucose metabolism-related indicators, and nephrotic indicators after 24 weeks compared to baseline in the test drug (SGLT2 inhibitor, DPP4 inhibitor, TZD): fasting plasma glucose, fasting insulin, HOMA-IR (calculated), HOMA-beta (calculated), albumin/creatinine ratio;Safety related indicators: BUN, creatine, AST, ALT, hypoglycemia and number of abnormal cases | — |
Countries
Korea, Republic of
Contacts
Public ContactByung-Wan Lee
Yonsei University
Outcome results
None listed