Prospective observational study of SGLT2 inhibitor, ipragliflozin in patients with type 2 diabetes

Prospective observational study of SGLT2 inhibitor, ipragliflozin in patients with type 2 diabetes - Prospective observational study of SGLT2 inhibitor, ipragliflozin in patients with type 2 diabetes

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1090220182

Enrollment

600

Registered

2014-06-25

Start date

2014-06-18

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

Intervention type: Name of intervention: Dose form / Japanese Medical Device Nomenclature: Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: *Patients with type 2 diabetes *Age 20 years or older, but 75 or younger *Patients with insufficiently controlled diabetes who are continuing diet therapy and/or exercise therapy or drug therapy *HbA1c 6.0% or more, but less than 9.5% *Ability to give written informed consent

Exclusion criteria

Exclusion criteria: *Patients with type 1 diabetes *History of metabolic acidosis, severe ketosis, diabetic coma or total coma within 6 months *Patients with severe infectious disease ,before or after surgery, or sever trauma *Patients with moderate or severe renal dysfunction (serum creatinine level 1.5 mg/dL and more for male, 1.3 mg/dL and more for female) *Occurrence of stroke, myocardial infarction or vascular complication required hospitalization within 6 months *Under treatment with SGLT-2 inhibitors *Pregnant, women on lactation or possibly pregnant women, or plan to pregnant during the study *History of hypersensitivity to SGLT-2 inhibitors *Ineligible patients according to the investigator's judgment

Design outcomes

Primary

Measure	Time frame
Change in HbA1c level from baseline to Week 24 Number of hypoglycemic episodes and other adverse events	—

Secondary

Measure	Time frame
Change in the amount or ratio of the following biomakers from baseline to Week 24: HbA1c (except in the case of Week 24), fasting serum glucose level, fasting serum insulin level, HOMA-beta and HOMA-R Body weight and waist circumference Serum lipid level (TC, TG, HDL-C, LDL-C and non-HDL-C) Blood pressure Renal function (eGFR, urinary and albumin) High molecular weight adiponectin and high sensitive CRP *Medication adherence (from a questionnaire)	—

Measure

Time frame

Change in the amount or ratio of the following biomakers from baseline to Week 24: *HbA1c (except in the case of Week 24), fasting serum glucose level, fasting serum insulin level, HOMA-beta and HOMA-R *Body weight and waist circumference *Serum lipid level (TC, TG, HDL-C, LDL-C and non-HDL-C) *Blood pressure *Renal function (eGFR, urinary and albumin) *High molecular weight adiponectin and high sensitive CRP *Medication adherence (from a questionnaire)

—

Countries

Japan

Contacts

Public ContactYoshihiko Hori

General Incorporated Association Nagoya Medical Association

yoshihiko_hori@ishikai.nagoya+81-52-979-7071

Outcome results

None listed

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