Direct comparison of TOfogliflozin and iPragliflozin on hyper-hypoglycemia using Continuous Glucose Monitoring system (TOP-CGM)

Direct comparison of TOfogliflozin and iPragliflozin on hyper-hypoglycemia using Continuous Glucose Monitoring system (TOP-CGM) - Tofogliflozin and continuous glucose monitoring

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018265

Enrollment

Registered

2015-07-10

Start date

2015-07-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

Tofogliflozin and wash out and Ipragliflozin Ipragliflozin and wash out and Tofogliflozin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Diagnosed as Type 2 diabetes (2)20=<informed conscent age<65 (3)22.0=<BMI<45 (4)Registration inspection before 4 weeks or more, patients are administered without prescription change in the regimen of diet and exercise therapy and SU (5) With estimated glomerular function >= 45 ml/min/1.73m2 (6)Subjects who give consent document about participation in the clinical study

Exclusion criteria

Exclusion criteria: (1) Has hypersensitivity to tofogliflozin and ipragliflozin or any other excipient of them (2) With severe ketosis, diabetic coma, or precoma (3) With severe infection, pre or post-surgery, and serious trauma (4)Has arteriosclerotic disease (myocardial infarction, stroke and so on) and history of them (5) End-stage renal disease (ESRD) undergoing hemodialysis (6) With severe liver dysfunction (7) Has insulin therapy (8) Entered already with another clinical trials (9) Considered as inadequate by the investigator

Design outcomes

Primary

Measure	Time frame
Time under 70mg/dl using continuous glucose monitoring system	—

Secondary

Measure	Time frame
(1) CGMS measurements (2) Changes in the variables listed below. 1-Fasting plasma glucose and HbA1c(NGSP value) 2-serum creatinine, BUN, Na, K, ,Cl, Mg, Ca, P, uric acid,ketone bodies(total ketone body, Acetoacetic acid and beta-hydroxybutyrate), glycemic related hormones(proinsulin, insulin, c-peptide, glucagon, free fatty acid) 3-urinanalysis(Na, K, Cl, Ca, creatinine, urine volume, urine glucose) 4- Reactive hyperemia index (RHI) (3) Meal tolerance test measurements	—

Measure

Time frame

(1) CGMS measurements (2) Changes in the variables listed below. 1-Fasting plasma glucose and HbA1c(NGSP value) 2-serum creatinine, BUN, Na, K, ,Cl, Mg, Ca, P, uric acid,ketone bodies(total ketone body, Acetoacetic acid and beta-hydroxybutyrate), glycemic related hormones(proinsulin, insulin, c-peptide, glucagon, free fatty acid) 3-urinanalysis(Na, K, Cl, Ca, creatinine, urine volume, urine glucose) 4- Reactive hyperemia index (RHI) (3) Meal tolerance test measurements

—

Countries

Japan

Contacts

Public ContactHiroko Mori

University of Occupational and Environmental Health First Department of Internal Medicine, School of Medicine

morihiro@med.uoeh-u.ac.jp+8100936031611

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026