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

JRCT ID: jRCT1031240269

Registered date:09/08/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: hepatogenous diabetes
• Date of first enrollment: 09/08/2024
• Target sample size: 30
• Study type: Interventional
• Intervention(s): We investigate the glucose profile of patients using continuous glucose monitoring (CGM) before initiating treatment with imeglimin.

Outcome(s)

• Primary Outcome: Indicators of blood glucose variability before and after imeglimin administration.

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Miyatsuka Takeshi