Type 2 diabetes mellitus
Conditions
Interventions
Oral administration of luseogliflozin 2.5 mg once daily before or after breakfast for 28 weeks
Sponsors
The Institute for Adult Diseases, Asahi Life Foundation
Tomonaga Clinic, Center for Diabetes and lifestyle-related diseases
Mitsui Memorial Hospital
Tanaka Internal Medicine Omiya Diabetes, Endocrinology and Metabolism Clinic
Shinjuku Mitsui Building Clinic
University of Toyama
Higashi Kurume Ekimae Clinic
Tokyo Gakugei University
Genki Plaza Medical Center For Health Care
Kumanomae Nishimura Medical Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with HbA1c (NGSP value) from >=6.9% to <=10.5% at screening 2) Patients receiving certain dietary therapy continuously from at least 12 weeks prior to the start of administration of the study drug 3) Patients not taking diabetic medication in period from at least 12 weeks prior to the start of administration, or taking diabetic medication continuously from at least 12 weeks beforehand with the same dosage and administration 4) Patients aged >=20 years at time of obtaining written informed consent 5) Patients who are capable of walking unassisted 6) Patients who have been explained details of the study, understood them, and given written informed consent for participation.
Exclusion criteria
Exclusion criteria: 1) Patients with diabetes other than type 2 diabetes 2) Patients with a history of cardiovascular events such as cerebral infarction and myocardial infarction. 3) Patients with serious renal or hepatic dysfunction 4) Patients with malignant tumors (those who have a history of malignant tumors but are currently receiving no treatment and had no recurrence, and those considered unlikely to have any recurrence during the study period are eligible for the study). 5) Patients with repeated genital or urinary tract infections 6) Patients with eGFR <=30 mL/min/1.73 m2 7) Patients with BMI <=20 8) Patients for whom dosage and administration of concomitant antidiabetic drugs have been changed within the 12 weeks prior to the start of administration of the study drug. 9) Patients who have administered a SGLT2 inhibitor within 6 months prior to the start of administration of the study drug 10) Patients whose answers to the questionnaire at week 0 were not collected before the start of administration. 11) Patients deemed unsuitable for participation in the study by the investigator or sub-investigator due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in QOL from 0 - 24 weeks: QOL to be assessed using the following questionnaires: DTSQ SGLT2i-Q (SGLT2 inhibitor Questionnaire : original questionnaire) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Changes in QOL from 0 - 12 weeks (DTSQ, SGLT2i-Q) 2) Body weight, BMI, blood pressure, abdominal circumference, pulse rate 3) Blood tests HbA1c, fasting blood glucose, triglycerides, HDL-C, uric acid, AST, ALT, gamma-GTP, red blood cells, Hb, Ht, white blood cells, platelets, Cr, albumin, Na, Cl, K, BUN, osmotic pressure, eGFR 4) Urinalysis (Qualitative) urinary protein, urinary glucose, uric blood, urobilinogen, specific gravity (Quantitative) Na, Cl, K, Cr, UUN, urinary glucose, urinary protein, urinary osmotic pressure 5) Measurement of 24-hr urine volume/ liquid intake 24-hr urine volume, 24-hr liquid intake, urination frequency (24-hr, daytime, nighttime) 6) Scoring assessments Proportion of patients with improvement in metabolic syndrome Fatty Liver Index | — |
Countries
Japan
Contacts
Public ContactKou Kayukawa
Nouvelle Place Inc. Research Management Office
Outcome results
None listed