patients with type 2 diabetes mellitus
Conditions
Interventions
Oral luseogliflozin 2.5 mg once daily after breakfast and before breakfast
Sponsors
Regulatory mechanism of body composition through SGLT2 study group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with HbA1c (NGSP value) between 7.0% and 10.5% at the time of informed consent. 2) Patients who have been receiving specific diet for more than 8 weeks at the time of initiation of luseogliflozin. 3) Patients who have not taken any antidiabetes agents for more than 8 weeks or have been taking one oral hypoglycemic agent at the same dose. 4) Patients with BMI between 20.0 and 35.0 at the time of informed consent. 5) Patients (regardless of gender) who are aged 20 to 65 at the time of informed consent. 6) Outpatients 7) Patients who can receive an explanation before the participation in the study understand the contents and provide written informed consents by themselves.
Exclusion criteria
Exclusion criteria: 1) Patients with diabetes mellitus other than type 2 diabetes mellitus (type 1 diabetes mellitus, diabetes mellitus due to specific mechanism/ diseases other than type 2 and gestational diabetes, etc.) 2) Patients with severe renal impairment (nephrotic syndrome, renal failure and dialysis procedure, etc.) 3) Patients with severe hepatic dysfunction (hepatic cirrhosis, etc.) 4) Patients with severe cardiac disorder (cardiac failure, etc.), myocardial infarction and cerebral infarction or a previous history of these diseases within 6 months prior to the study 5) Patients with severe diabetic microangiopathy (despite continuous treatment, inadequately-controlled diabetic retinopathy and diabetic neuropathy, etc.) 6) Patients with malignant tumour or a previous history of malignant tumour (however, included those who were not treated for them, do not have recurrence and will not have a recurrence during the study can be included). 7) Patients who have a previous history of hypersensitivity to luseogliflozin 8) Severe chronic drinkers 9) Pregnant or possibly pregnant women, women who hope to be pregnant and lactating women during the study 10) Those considered inappropriate for the study by physicians in charge of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight, amounts of fat and fat-free mass by DXA as well as fluctuations in composition estimated from amounts of subcutaneous fat and visceral fat by CT scan | — |
Secondary
| Measure | Time frame |
|---|---|
| - Glycemic control - Degree of obesity - Lipid parameter - Blood pressure - QOL - Adverse events and adverse reaction incidence | — |
Countries
Japan
Outcome results
None listed