Investigation on Renal Protective Effect by Luseogliflozi

Not Applicable

• Conditions: type 2 diabetes

• Registration Number: JPRN-jRCTs071180077
• Lead Sponsor: Kitaoka Masafumi

Brief Summary

eGFR slightly lowered after 6-month Luseogliflozin administration, and after that it remained unchanged through 48 weeks. The amount of urine protein also had been decreased. It was shown that Luseogliflozin has the effects of renal protection and weight loss in the elderly in similar manner as in the young people. It was suggested that Luseogliflozin is expected to have effects of renal protection as well as improving blood glucose level for elder patients with type 2 diabetes who have renal disorders.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-26
• Study Completion: 2020-07-08
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1)A patient whose eGFR is less than 60 mL/min/1.73 m2
2)A patient aged 65 years or older
3)A patient whose HbA1c is 6.5% or more but less than 9.0%
4)A patient from whom written informed consent on his/her participation in this study can be obtained directly

Exclusion Criteria

1)A patient with type 1 diabetes
2)A patient who received an SGLT2 inhibitor within 8 weeks before the start of the treatment phase
3)A patient with severe ketosis, diabetic coma, or precoma
4)A patient with severe infections, before and after surgery, serious trauma
5)A patient with a medical history of hypersensitivity to components of SGLT2 inhibitors
6)A patient with pituitary gland dysfunction or adrenal gland dysfunction
7)A patient showing poor nutritional status, starvation status, irregular meal intake, insufficient dietary intake, or hyposthenia
8)A patient with a medical history of urinary tract infections due to urinary outflow disorder, etc., a patient with a medical history of severe genital infection, or patients currently infected
9)A patient who is prone to dehydration
10)A patient with severe renal dysfunction or a patient with end-stage renal failure during dialysis
11)A patient who is judged unsuitable for participation in this study by Principal Investigator or Subinvestigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified