Investigation on Renal Protective Effect by Luseogliflozin

JRCT ID: jRCTs071180077

Registered date:26/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: type 2 diabetes
• Date of first enrollment: 09/08/2018
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Luseogliflozin 2.5 mg will be administered once a day for 48 weeks. In principle, 2.5 mg as Luseogliflozin will be administered once a day, but if the principal investigator or co-investigator judges that efficacy is insufficient, increase to 5 mg once a day is permissible.

Outcome(s)

• Primary Outcome: eGFR variation before and after therapy at Week 48

Secondary Outcome

Variations of the following items before and after therapy at Week 48
1)Physical findings
Body weight, BMI, blood pressure, pulse pressure, mean arterial pressure, pulse
2)Hematologic examination
HbA1c, fasting blood glucose level, ketone body fraction (acetoacetic acid, 3-hydroxybutyric acid, total ketone body)
3)Urinalysis
Urinary albumin/creatinine ratio, urine sugar (qualitative)
4)Double product

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kitaoka Masafumi
• Secondary ID(s): UMIN000032005