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Efficacy and Safety of Increasing Dose of Luceogliflozin in Type 2 Diabetic Patients with Inadequate Glycemic Control

Efficacy and Safety of Increasing Dose of Luceogliflozin in Type 2 Diabetic Patients with Inadequate Glycemic Control - Efficacy and Safety of Increasing Dose of Luceogliflozin

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000045373
Enrollment
40
Registered
2021-09-03
Start date
2018-07-01
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

Type2 diabetes mellitus

Interventions

Patients with type 2 diabetes mellitus with inadequate glycemic control who are taking diet and exercise or oral hypoglycemic agents other than SGLT2 inhibitors will receive luseogliflozin 2.5 mg/day

Sponsors

Department Internal Medicine of Diabetes, Hematology and Collagen Diseases,Moji Medical Center, Kyushu Rosai Hospital, Japan Labor Healthand Safety Organization
Lead Sponsor
The First Department of Internal Medicine, University of Occupational and Environmental Health, Japan
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who meet all of the following criteria will be eligible. (1) Age 20 years or older, 89 years or younger (regardless of gender) (2) Patients with an HbA1c of 7.0% or higher (3) Patients who can give their consent to participate in this study.

Exclusion criteria

Exclusion criteria: (1) Patients on insulin (2) Pregnant women or women who may be pregnant (3) Patients with a history of hypersensitivity to luseogliflozin (4) Pregnant women or women who may be pregnant, women who wish to become pregnant, and women who are breast-feeding (5) Others who are judged by the investigator to be inappropriate for this study.

Design outcomes

Primary

MeasureTime frame
Change in HbA1c before and after luseogliflozin administration (2.5 mg/day, 5 mg/day)

Secondary

MeasureTime frame
Changes in (fasting) blood glucose, (fasting )insulin, triglycerides, LDL-cholesterol, HDL-cholesterol, eGFR, uric acid, AST, ALT, ganma-GTP, DBP, and SBP before and after luseogliflozin administration (2.5 mg/day, 5 mg/day)

Countries

Japan

Contacts

Public ContactTadashi Arao

Moji Medical Center, Kyushu Rosai Hospital, Japan Labor Health and Safety Organization Department Internal Medicine of Diabetes, Hematology and Collagen Diseases

t-arao@med.uoeh-u.ac.jp0933313461

Outcome results

None listed

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