None listed
Conditions
Interventions
Drug : Gemigliptin 50mg /Patients with type 2 diabetes who are insufficiently controlled by metformin and SGLT-2 inhibitor 2 are randomly assigned to gemiglobulin in the metformin-treated group and gi
Sponsors
Kyung Hee University Hospital at Gangdong
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Type 2 diabetic patients 2) 7% = HbA1c = 10% 3) Body mass index greater than 18.5 kg / m2 and less than 40 kg / m2 4) V1 (screening) Those who are taking metformin (not less than 1000mg per day and 2000mg per day) and SGLT2 inhibitors (dapagliflozin, ipragliflozin, empagliflozin) 5) A voluntary written consent to participate in this clinical trial.
Exclusion criteria
Exclusion criteria: ? GFR estimated to be less than 45 mL / min / 1.73 m 2 ? Patients with hypersensitivity or intolerance to DPP4 inhibitors ? cardiovascular collapse, acute myocardial infarction and septicemia, which can be caused by conditions such as kidney disease or drug therapy is needed for patients with congestive heart failure ? Patients with acute or chronic metabolic acidosis, including type 1 diabetes, diabetic ketoacidosis with or without coma, and patients with a history of ketogenic acidosis ? Patient with a history of cardiovascular disease, myocardial infarction or PCI (stenting or ballooning) within 6 months ? V1 (screening) Patients who used other hypoglycemic agents other than metformin and SGLT2 inhibitor (DPP4 inhibitor, sulphonylurea, glinide, a-glucosidase inhibitor, thiazolidinedione, GLP-1 RA, insulin) ? patients with malnutrition, starvation, weakness, pituitary dysfunction or adrenal insufficiency ? liver dysfunction (AST or ALT is more than 3 times the normal upper limit), ? Patient with pulmonary dysfunction of menopausal color or severe ? Patients with history of alcohol or substance abuse during the previous 3 months ? Pregnant women or possibly pregnant women, ? When you take the following medications All medicines, including generic medicines, should be consulted before taking any medicines. The following drugs are prohibited in combination with V1 (screening) for 4 weeks before the clinical trial (until the last visit). - diabetes drugs other than test drugs - Glucocorticoids - Anti-obesity drug - Cyclosporin, sirolimus, tacrolimus - Isotretinoin - Chemotherapy for cancer ? Any other patient who is deemed inappropriate by the examiner as the subject of the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare HbA1C changes | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of fasting blood sugar change;Comparison of postprandial blood glucose change;Compare the percentage of patients with HbA1c <7.0%;Compare the percentage of patients with HbA1c <6.5%;Comparison of HOMA-IR and HOMA-ß changes;Comparison of changes in lipid parameters;Comparing changes in urinary albumin;Comparison of changes in blood ketone bodies;Compare blood glucagon changes | — |
Countries
Korea, Republic of
Contacts
Public Contactjunghwa LEE
Kyung Hee University Hospital at Gangdong
Outcome results
None listed