Effect of tofogliflozin on pancreatic beta-cell functio

Phase 4

Recruiting

• Conditions: Type 2 diabetes

• Registration Number: JPRN-jRCTs011230006
• Lead Sponsor: akamura Akinobu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change in disposition index at 4 weeks from baseline

Secondary Outcome Measures

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