CHAT-Lu

JRCT ID: jRCTs051180060

Registered date:14/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type2 diabetes mellitus
• Date of first enrollment: 03/04/2018
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Peroral prescription of Luseogliflozin 2.5mg once daily brfore or after breakfast for 104 weeks. At more than 6 month post prescription, if HbA1c is more than 7.4%, the dose should be increased to 5 mg.

Outcome(s)

• Primary Outcome: Trend of eGFR value from the start of treatment 104 weeks after starting administration by eGFR value before administration.

Secondary Outcome

Changes in eGFR value at 52 weeks, and changes in body weight and resting double product after 52 and 104 weeks after starting administration by eGFR value before administration.
Changes in the treatment of lifestyle diseases.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Diabetes patients with HbA1c at 6.5% or more and less than 10.0%
eGFR value of 30 to 90 ml / min / 1.73 m 2 at the start of administration

Exclude criteria

SGLT-2 inhibitors taken within 6 months
Severe ketosis, diabetic coma or precoma, cases of type 1 diabetes
Severe infection, cases before and after surgery, cases of severe trauma
Pregnancy, breast-feeding, possible cases of pregnancy
Cases with a history of hypersensitivity to the ingredients of Luseogliflozin
Research researcher judged unsuitable as a research subject.

Related Information

• Primary Sponsor: Urata Hidenori
• Secondary Sponsor: Taisho Pharmaceutical Co., Ltd.
• Secondary ID(s): UMIN000029975