Investigation for clinical efficacy and safety of ipragliflozin 50mg and 100mg on type 2 diabetes

Investigation for clinical efficacy and safety of ipragliflozin 50mg and 100mg on type 2 diabetes - HARUKA study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000016131

Enrollment

600

Registered

2015-01-06

Start date

2015-01-06

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

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Poorly-controlled Type II diabetes with diet and exercise therapy or additional treatment of various diabetic drugs 2) Changes within +- 0.5% of HbA1c 3) 6.5%<HbA1C<10% 4) Written informed consent by each subjects 5) BMI>20kg/m2

Exclusion criteria

Exclusion criteria: 1) Type 1 diabetes, patients with other types of diabetes or pregnancy diabetes 2) History of severe ketoacidosis diabetic coma or profound come within 6 months 3) Severe infection, perioperative or severe trauma 4) Moderate renal insufficiency(male >1.5mg/dL, female>1.3mg/dL) 5) Severe hepatic impairment 6) History of requirement of hospitalization for severe CV event within 6 months other 7) Patients with pregnancy, breast-feeding, childbearing potential or plan of pregnancy 8) Patients with neuropathic bladder or dysuria 9) Patients with treatment of diuretic drug 10) Patients with SGLT2 treatment at start of this study 11) Patients who has an episode of sensitivity of SGLT-2 12) Patients who are not eligible judged by investigator

Design outcomes

Primary

Measure	Time frame
Changes of HbA1c at 52weeks treatment after initiation	—

Countries

Japan

Contacts

Public ContactHaruo Nishimura

Osaka Saiseikai Nakatsu Hospital Division of diabetes and endocrinology

hnis@kuhp.kyoto-u.ac.jp06-6372-0333

Outcome results