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Study on changes in urinary glucose concentrations in Type 2 diabetes patients treated with the selective SGLT2 inhibitor luseogliflozi

Not Applicable
Conditions
Patients with Type 2 diabetes
Registration Number
JPRN-UMIN000018806
Lead Sponsor
Medical corporation Jinnouchi society Jinnouchi Hospital
Brief Summary

The urine sugar discharge amount changed significantly before and luseogliflozin taking starting, but after it began there were slightly fluctuations. A weight change was a plateau after starting after 3 months, but I can think it doesn't depend on decline of the urine sugar discharge amount. Improvement of the numerical value related to insulin resistance was seen more than the 3rd month.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
30
Inclusion Criteria

Not provided

Exclusion Criteria

(1) Patients diagnosed with diabetes other than Type 2 diabetes, including Type 1 diabetes, diabetes associated with diseases other than Type 2 diabetes and gestational diabetes (2) Patients with severe renal function impairment, including nephrotic syndrome, renal failure and dialysis (3) Patients with severe hepatic function impairment, including cirrhosis (4) Patients with severe heart diseases, including heart failure, myocardial infarction and cerebral infarction, or patients with prior history of any of these diseases during the past 6 months (5) Patients with severe diabetic microvascular diseases, including diabetic retinopathy and diabetic neuropathy that does not sufficiently respond to treatment (6) Patients with concurrent or prior history of malignant tumors, excluding those not receiving treatment for their disease and who have not experienced recurrence and those who are not likely to experience recurrence during participation in the study (7) Patients who have previously developed hypersensitivity to luseogliflozin (8) Patients who are alcoholics (9) Females who are pregnant or are likely to be pregnant, or those who want to become pregnant during participation in the study and nursing mothers (10) Patients who the physician in charge determines as ineligible for the study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
rinary glucose level, CGM, HbA1c, fasting blood glucose level and body weight from before the start of treatment until completion (Week 24) or discontinuation of treatment
Secondary Outcome Measures
NameTimeMethod
rine volume at measurement of urinary glucose, subcutaneous fat, visceral fat, insulin, EPA/AA ratio, FFA, ghrelin, blood ketone bodies, 1.5-anhydro-D-glucitol, and QOL from before the start of treatment until completion (Week 24) or discontinuation of treatment
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