Effect of tofogliflozin on pancreatic beta-cell function

JRCT ID: jRCTs011230006

Registered date:09/05/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type 2 diabetes
• Date of first enrollment: 01/06/2023
• Target sample size: 70
• Study type: Interventional
• Intervention(s): Subjects will be randomly assigned to either the 'tofogliflozin group' or the 'metformin group' for four weeks of treatment. In the "tofogliflozin group", administration is started at 20 mg/day tofogliflozin, and in the "metformin group", administration is started at 500 mg/day metformin.

Outcome(s)

• Primary Outcome: The change in disposition index at 4 weeks from baseline

Secondary Outcome

1) Changes in the other blood and urinary tests
2) Changes in weight, abdominal circumference, blood pressure and pulse
3) Changes in beta-cell function indices other than the primary endpoint
4) Changes in insulin resistance indices
5) Changes in scores of hepatic steatosis
6) The factors associated with improvement of beta-cell function indices and secondary endopoints
7) Rate of improvement to impared glucose tolerance or normal glucose tolerance

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

1) Age 20-90 years old
2) HbA1c 6.5-9.0% and urine ketone negative
3) Patients with type 2 diabetes who have not been taking any hypoglycemic agents more than 3 months
4) Written informed consent

Exclude criteria

1) History of anaphylaxis of tofogliflozin
2) History of anaphylaxis of metformin
3) History of lactic acidosis
4) Unstable retinopathy
5) Severe hepatic, renal, or cardiac dysfunction
6) Pregnancy or possibly pregnant females
7) Severe ketosis, diabetic coma
8) Severe infection, surgery, serious trauma
9) Deficiency of insulin secretion
10) Dehydration or possibly dehydration
11) Excessive alcohol consumption
12) Malnutrition, starvation, debility, pituitary or adrenal insufficiency
13) Inability to consume an appropriate diet
14) Incompatibility with the trial for other reasons, as determined by the physician

Related Information

• Primary Sponsor: Nakamura Akinobu
• Source(s) of Monetary Support: Kowa Co., Ltd.