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Efficacy and safety of imeglimin in patients with diabetes complicated with liver cirrhosis

A single-center prospective interventional study on the efficacy and safety of imeglimin in patients with diabetes complicated with liver cirrhosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1031240269
Enrollment
30
Registered
2024-08-09
Start date
2024-08-09
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

hepatogenous diabetes

Interventions

We investigate the glucose profile of patients using continuous glucose monitoring (CGM) before initiating treatment with imeglimin.

Sponsors

Miyatsuka Takeshi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1, Liver cirrhosis 2, Child-Pugh A or B 3, HbA1c levels between 6.5% and 10.0% from 4 to 12 weeks before the beginning of this trial 4, Patients scheduled to receive imeglimin who are eligible for its use

Exclusion criteria

Exclusion criteria: 1, Before or after surgery or severe trauma 2, Alcohol consumption more than 30 g/day in male, more than 20 g/day in female 3, Liver cirrhosis Child-Pugh C 4, Presence of malignant tumors 5, Severe anemia Hb less than 7 g/dL 6, Chronic kidney disease eGFR less than 45 mL/min/1.73 m2 7, Patients using implanted medical devices 8, Patients who cannot fully understand the explanaition because of mental developmental retardation or linguistic problems 9, Patients deemed by the principal investigator or study team to be unable to participate

Design outcomes

Primary

MeasureTime frame
Indicators of blood glucose variability before and after imeglimin administration.

Secondary

MeasureTime frame
1, Change in HbA1c 2, Changes in body weight, fat mass, muscle mass, and lean body mass 3, Change in C-peptide 4, Presence or absence of severe hypoglycemia

Contacts

Public ContactNagisa Aoki

Diabetes, Endocrinology, and Metabolism, School of Medicine, Kitasato University

nagisa050105@gmail.com+81-42-778-8111

Outcome results

None listed

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