None listed
Conditions
Interventions
Drug : Test Group: The total duration of treatment is 24 weeks. The underlying drug (Metformin) is administered without any change in dose. And Gemidapa(Gemigliptin 50mg + Dapagliflozin 10mg) is admin
Sponsors
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A patient 19 years of age and under 80 years of age. 2) A patient who was diagnosed with type 2 diabetes more than a year ago at the time of screening. 3) A patient who has taken constantly Metformin =1,000 mg + Dapagliflozin 10 mg combination therapy (including combination administration) for more than 8 weeks ago at the time of screening. 4) A patient who meet the following criteria: 7.0% = HbA1c <11.0%; FBS =270 mg/dL at the time of screening. 5) A patient with an eGFR (using MDD formula) = 45ml/min/1.73m2 at the time of screening. 6) A patient with Fasting C-peptide = 0.6 ng/mL at the time of screening. 7) In the case of women of childbearing age, A patient who has consented to appropriate contraception during the clinical trial period. 8) A patient who is appropriate to understand this clinical trial under the investigator judgement. 9) A patient who consented to participate in the trial voluntarily after listening in detail and understanding about clinical trial.
Exclusion criteria
Exclusion criteria: 1) A patient who took the medication (Gemidapa or Glimepiride) within 18 days prior to screening. 2) A patient who is taking or needs the medication that is possible affect blood sugar control (immuno suppressive, steroid, etc.) except for the underlying medications (metformin, SGLT-2 inhibitors) 3) A patientwith liver disease (more than 2.5 times upper limit of normal AST or ALT or total bilirubin). 4) Severe cardiac dysfunction: New York Heart Association (NYHA) Class III or IV. 5) A patient with hypopituitarism or adrenal insufficiency. 6) A patient with major surgery, severe infections, and severe trauma within six months prior to screening. 7) A patient with a history of malignancy with no remission within five years prior to screening. 8) A patient with hypersensitivity to Medications or ingredients used in this clinical trial. 9) A patient with is drinking excessively (more than 30g per day, more than 5 days per week) within a year prior to screening. 10) Pregnant women or lactating women. 11) A patient who participated in another clinical trial within 90 days prior to screening(excluding observational studies). 12) A patient who is inappropriate to understand this clinical trial under the investigator judgement. 13) In addition to the above, A patient who is inappropriate to understand this clinical trial under the investigator judgement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin A1c variation volume;Blood glucose variability indicators(Mean Glucose, Standard Deviation, Coefficient of Variation) measured by Continuous Glucose Monitoring;Adverse effect;vital sign;physical examination;laboratory test | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemoglobin A1c variation volume;Blood glucose variability indicators(Mean Glucose, Standard Deviation, Coefficient of Variation) measured by Continuous Glucose Monitoring;Blood glucose variability indicators(Glucose Management Indicator, Time In Range, Time Below Range, Time Above Range, Mean Amplitude of Glycemic Excursions) measured by Continuous Glucose Monitoring;Fasting Blood Sugar variation volume;Estimated Glomerular Filtration Rate variation volume;Albuminuria varoation volume;Incidence of hyperglycemia salvage therapy;Lipid profile(Total cholesterol, triglyceride, High-Density Lipoprotein cholesterol, Low-Density Lipoprotein cholesterol) variation volume;Homeostasis Model Assessment of Insulin Resistance variation volume;Homeostasis Model Assessment of Beta-cell Function variation volume;weight variation volume;Blood sugar variation volume and variability of moderate Kidney disorder patient (Baseline eGFR 45-59 mL/min/1.73m2) | — |
Countries
Korea, Republic of
Contacts
Public ContactSangah Jang
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Outcome results
None listed