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

JRCT ID: jRCTs031180117

Registered date:13/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type 2 diabetes
• Date of first enrollment: 20/11/2018
• Target sample size: 12
• Study type: Interventional
• Intervention(s): Tofoglyfrozin20mg/day 8weeks

Outcome(s)

• Primary Outcome: The effect of Tofogliflozin (SGLT2 inhibitor) on insulin clearance

Secondary Outcome

After administration of Tofogliflozin
-Intrahepatic lipid
-Intramyocellular lipid
-Visceral fat area
-Subcutaneous fat area
-Body weight, Body composition
-Endogenous glucose production
-Insulin sensitivity
-Metabolic flexibility
-Metabolome analysis

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: <= 65age old
• Gender: Male

Include 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

Exclude 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

Related Information

• Primary Sponsor: Tamura Yoshifumi
• Source(s) of Monetary Support: Kowa company.Ltd.
• Secondary ID(s): UMIN000031686