A study on the efficacy and safety of ipragliflozin monotherapy or combination therapy under clinical use condition: continuous glucose monitoring and self monitoring of urine glucose

A study on the efficacy and safety of ipragliflozin monotherapy or combination therapy under clinical use condition: continuous glucose monitoring and self monitoring of urine glucose - A study on the efficacy and safety of ipragliflozin monotherapy or combination therapy under clinical use condition: continuous glucose monitoring and self monitoring of urine glucose

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014388

Enrollment

Registered

2014-06-26

Start date

2014-06-27

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

Orally administration of 50 mg ipragliflozin once a day, pre or post breakfast for 12 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Aged from 20 to 70 years at providing consent 2) Poorly controlled patients who undergoes diet/exercise therapy or hypoglycemic agent at least 6 weeks 3) HbA1c >= 7.0% 4) BMI >= 22.0 kg/m2 5) Provide written informed consent

Exclusion criteria

Exclusion criteria: 1) Type 1 diabetes 2) With severe ketosis, diabetic coma, or precoma 3) With severe infection, pre or post surgery, and serious trauma 4) With moderate or severe renal dysfunction (Serum Creatinin male: >= 1.5 mg/dL, female: >= 1.3 mg/dL) 5) Is receiving SGLT-2 inhibitor, insulin at initiation 6) Is nursing or pregnant or planned to become pregnant 7) Has history of hypersensitivity to ipragliflozin or any other excipient of ipragriflozin 8) Considered as inadequate by the investigator

Design outcomes

Primary

Measure	Time frame
Change in HbA1c from baseline to 12 weeks	—

Secondary

Measure	Time frame
Change and percent change in following items from baseline to 12 weeks 1) AUC of blood glucose 160 mg/dL or less by CGM 2) AUC of urinary glucose by SMUG 3) 2-hour postprandial blood glucose and urinary glucose levels 4) Body composition (body fat, and body water) 5) Glycoalbumin (GA) 6) Body weight 7) Waist circumference 8) Serum lipids 9) Blood pressure 10) Other information such as diet record, include DTR-QOL	—

Measure

Time frame

Change and percent change in following items from baseline to 12 weeks 1) AUC of blood glucose 160 mg/dL or less by CGM 2) AUC of urinary glucose by SMUG 3) 2-hour postprandial blood glucose and urinary glucose levels 4) Body composition (body fat, and body water) 5) Glycoalbumin (GA) 6) Body weight 7) Waist circumference 8) Serum lipids 9) Blood pressure 10) Other information such as diet record, include DTR-QOL

—

Countries

Japan

Contacts

Public ContactMitsutoshi Kato

Kato clinic of Internal medicine Medical director

katom@gol.com03-5668-2161

Outcome results

None listed

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