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Study on the glucose-lowering effect and metabolic benefit of SGLT2 inhibitors

Prospective observational study on metabolic changes induced by SGLT2 inhibitors or insulin treatment in a single-center, two-arm, open-label design - prospective observational study on metabolic changes induced by SGLT2 inhibitors or insulin treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000052955
Enrollment
60
Registered
2023-11-30
Start date
2020-08-05
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

Diabetes mellitus

Interventions

None listed

Sponsors

Department of Internal Medicine, Kurume University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria comprised a diagnosis of type 2 diabetes mellitus with HbA1c 6.5% or more, age between 20 and 79 years, a stable antidiabetic regimen with insulin for at least 8 weeks prior to the study, and no prior use of SGLT2 inhibitors.

Exclusion criteria

Exclusion criteria: Exclusion criteria encompassed pregnant or breastfeeding women, patients with malignant disease, severe infections (including urinary tract infections), severe trauma, or recent surgery.

Design outcomes

Primary

MeasureTime frame
Changes in the levels of HbA1c.

Secondary

MeasureTime frame
Changes in the levels of glycated albumin, fasting blood glucose, and urinary albumin/creatinine ratio.

Countries

Japan

Contacts

Public ContactMoeko Sakamoto

Department of Internal Medicine, Kurume University School of Medicine Division of Endocrinology and Metabolism

matsumoto_moeko@kurume-u.ac.jp0942-31-7563

Outcome results

None listed

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