Assessing patient body composition following treatment with sodium glucose co-transporter 2 inhibitor for type 1 diabetes mellitus

Assessing patient body composition following treatment with sodium glucose co-transporter 2 inhibitor for type 1 diabetes mellitus - Assessing patient body composition following treatment with sodium glucose co-transporter 2 inhibitor for type 1 diabetes mellitus

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000042407

Enrollment

Registered

2020-11-10

Start date

2019-03-26

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 1 diabetes mellitus

Interventions

50mg of ipragliflozin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Type 1 diabetes mellitus obtained consent to participate in research Patients with glycated hemoglobin (HbA1c) of 6.5% or higher and less than 10% Patients with body mass index (BMI) of 18.5 kg/m2 or higher

Exclusion criteria

Exclusion criteria: Patients who do not agree to participate in the study Patients judged by the attending physician that there is no indication for SGLT2 inhibitor administration

Design outcomes

Primary

Measure	Time frame
Changes of body composition measured by impedance method 52 weeks after ipragliflozin administration.	—

Secondary

Measure	Time frame
To assess safety and efficacy, the data prior to and three months subsequent of the oral administration of the SGLT2 inhibitor were collected such as body mass index, glycated hemoglobin (HbA1c), and glycemic variability were obtained from flash glucose monitoring (FGM) systems (Free Style Libre; Abbott Diabetes Care, Witney, UK) measured for three months prior to and three months subsequent of the oral administration of the SGLT2 inhibitor. Retrospective data included the insulin dose, the number of severe hypoglycemia incidence requiring assistance, diabetic ketoacidosis, and other side effects.	—

Measure

Time frame

To assess safety and efficacy, the data prior to and three months subsequent of the oral administration of the SGLT2 inhibitor were collected such as body mass index, glycated hemoglobin (HbA1c), and glycemic variability were obtained from flash glucose monitoring (FGM) systems (Free Style Libre; Abbott Diabetes Care, Witney, UK) measured for three months prior to and three months subsequent of the oral administration of the SGLT2 inhibitor. Retrospective data included the insulin dose, the number of severe hypoglycemia incidence requiring assistance, diabetic ketoacidosis, and other side effects.

—

Countries

Japan

Contacts

Public ContactRyoichi Ishibashi

Kimitsu Chuo Hospital Department of Medicine, Division of Diabetes, Endocrinology and Metabolism

ishibashi-cib@umin.net+81-438-36-1071

Outcome results

None listed

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