Type 2 Diabetes Mellitus
Conditions
Interventions
Group A: Administration of luseogliflozin
Group B: Administration of DPP-4 inhibitors
Sponsors
Japan Physicians Association
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria are included in this study. 1. type 2 diabetes mellitus patients. 2. Male and female patients who are at age of 20 years or older when giving their consent. 3. Patients who did not use antidiabetic medication within 8 weeks before consenting, or patients who used anti-diabetic therapeutic agents other than SGLT2 inhibitors and DPP-4 inhibitors* and who did not change the usage and the dose of them within 8 weeks before consenting. * including once-weekly DPP-4 inhibitors. 4. Patients with HbA1c 7.0% or higher but no more than 8.5% within 12 weeks before consenting. 5. Patients with BMI 22 kg/m2 or higher. 6. Patients who can give their consent in a written form.
Exclusion criteria
Exclusion criteria: Patients who fall into any of the following criteria are excluded from participating in the study. 1. Type 1 diabetes mellitus or secondary diabetes 2. Patients who used insulin, GLP-1 analogs, or SU within 8 weeks before consenting 3. Patients who had myocardial infarction, cerebral infarction, or stroke within 12 weeks before giving their consent 4. Patients with severe liver disease (Patients with AST or ALT value five times or more of the upper limit of the stand value in each research institution) 5. Patients with serious renal disease (eGFR less than 30 mL/min/1.73m2) 6. Patients with unstable hypertension and dyslipidemia 7. Dehydrated patients (patients complain to have a symptom of dehydration) 8. Patients with urinary tract infection or genital infection 9. Patients who are breastfeeding, pregnant, possibly pregnant, or planning to be pregnant 10. Contraindication: patients with hypersensitivity to any medical component of each study drug 11. Patients who need legal representative for giving consent 12. Patients with other conditions that the investigator/researcher thinks inappropriate for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achievement ratio of patients who improved three or more endpoints among five endpoints listed below from baseline to week 52 (achievement ratio of composite endpoint) HbA1c (change from baseline < 0) Body weight (change from baseline < 0) eGFR (change from baseline > 0) Blood pressure (change from baseline < 0) Pulse (change from baseline < 0) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Achievement ratio of the composite endpoint from baseline to week 24 2. Change of HbA1c from baseline 3. Change of body weight from baseline 4. Change of eGFR from baseline 5. Change of blood pressure from baseline 6. Change of pulse from baseline 7. Change of blood test values (or percent change in lipid biomarker values) from baseline - lipid biomarkers: HDL-chol, T-chol, LDL-chol, TG - hepatic biomarkers: AST, ALT, gamma-GTP - others: blood count (red blood cell, hemoglobin, hematocrit, leukocyte, platelet), uric acid, Amy 8. change of specific test values from baseline - blood test values: NT-proBNP, erythropoietin, reticulocyte - urine test values: urinary albumin/creatinine ratio, urinary creatinine 9. change of OHA-Q (questionnaire for patients QOL) score from baseline 10. change of waist circumference and BMI from baseline 11. frequency of adverse events | — |
Countries
Japan
Contacts
Public ContactHiroki Takayama
Soiken Inc. Clinical Study Support Division
Outcome results
None listed