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

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

Miyatsuka Takeshi

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

1-15-1, Kitazato, Minami-ku, Sagamihara, Kanagawa

miyatsuka.takeshi@kitasato-u.ac.jp

Aoki Nagisa

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

1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa

+81-42-778-8111

nagisa050105@gmail.com

Recruiting

Aug. 09, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

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

Both

hepatogenous diabetes

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

Indicators of blood glucose variability before and after imeglimin administration.

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

+81-42-778-8273

July. 17, 2024

No

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