The effect of Tofogliflozin (SGLT2 inhibitor) on endogenous glucose production and insulin clearance.

Not Applicable

• Conditions: Type 2 diabetes

• Registration Number: JPRN-jRCTs031180117
• Lead Sponsor: Tamura Yoshifumi

Brief Summary

1.Effect of a single dose of tofogliflozin on endogenous gluconeogenesis The decrease in PG levels induced by SGLT2i administration is required for the increase in EGP and decrease in insulin secretion. 2.Effect of tofogliflozin administration for 8 weeks on insulin clearance The insulin clearance was not altered after a single and 8-weeks administration of tofogliflozin.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-13
• Study Completion: 2019-08-31
• Results First Posted: 2020-12-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

Type 2 diabetes mellitus men
-BMI range 18.5 - 30 kg/m2
-HbA1c range 6.5 - 10.0%
-The patient who did not being changed the way to take diabetes medicines(additional dosage, discontinulation of administration or changing dosage) within 12 weeks before agreement acquisition
-Persons who gained document consent by the patient's free intention after having sufficient explanation for participation in this study and having sufficient understanding

Exclusion Criteria

-Type 1 diabetes mellitus
-Past history of taking Tofogliflozin
-BMI range:>30 or <18.5 kg/m2
-Liver dysfunction (AST, ALT => 51U/L,gamma-GTP over 101U/L)
-Renal dysfunction or eGFR level =< 60mL/min/1.73m2
-Patient with severe heart diseases (for example, heart failure and unstable angina) or the patient who occured myocardial infarction and anginal attack after 24 weeks ago from observation period
-Patient who had an apoplexy spasm (cerebral infarction and cerebral hemorrhage) within 24 weeks until agreement acquisition
-Patient with malignant tumor
-Patient with advanced diabetes complications (neuropathy , retinopathy and nephropathy)
-Patient of serious illness ketotic, a diabetic coma or the previous coma
-Patient with the endocrine diseases for which treatment is insufficient for hormone replenishment method of treatment (for example,pituitary disease, thyroid disease and adrenal disease)
-Anemia beyond the degree of middle class (hemoglobin < 9.5g/dL)
-Drunkard(for example 1 daily mean sake, by 3 gou and beer, more than 3 flagons)
-Subjects judged unsuitable to the study from staff

Study & Design

• Study Type: Interventional
• Study Design: Not specified