NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051220061

Registered date:12/07/2022

Effect of Imeglimin on Blood Glucose Variability

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedType 2 diabetes mellitus
Date of first enrollment15/07/2022
Target sample size60
Countries of recruitment
Study typeInterventional
Intervention(s)If the patient is taking oral hypoglycemic agents other than DPP-4 inhibitors, washout for at least 8 weeks, and oral imeglimin (1000 mg twice daily) or metformin (250 mg twice daily for the first 8 weeks, increasing to 500 mg twice daily after the first 8 weeks) for 20 weeks.

Outcome(s)

Primary OutcomeChange in glycemic index (Time in Range [TIR]) by CGM from 0-2 weeks to 16-18 weeks after randomization in the imeglimine group
Secondary Outcome(Efficacy endpoints) Change in glycemic indices and glycemic variability indices by CGM from 0-2 weeks to 16-18 weeks after randomization and change in HbA1c, 8-OHd G, HOMA-IR, HOMA-beta, adiponectin and lipid metabolism indices (TC, HDL-C, LDL-C, TG, FFA) and weight from baseline to each measurement point in the imegurimine and metformin groups (Safety endpoints) 1) Adverse events 2) Side effects 3) Serious adverse events 4) Noteworthy adverse events

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum< 75age old
GenderBoth
Include criteria1) Patients who have been diagnosed with type 2 diabetes at the time of obtaining consent 2) Patients who are between 20 and 75 years of age at the time of consent. 3) Patients whose HbA1c level measured at the time of eligibility test is between 6.5% and 9.5%. 4) Patients with a body mass index (BMI) of 18.5 k g/m2 or higher at the time of the eligibility test. 5) Patients who have given written consent to participate in this clinical study.
Exclude criteria1) Patients using insulin, glucagon-like peptide-1 receptor agonist (GLP-1 RA), or two or more oral hypoglycemic agents (including combination products containing two oral hypoglycemic agents) 2) Patients with contraindications listed in the package inserts for imeglimine, metformin, and the FreeStyle Libre Pro sensor and reader (contraindications for the FreeStyle Libre Pro sensor and reader: patients with pacemakers or other implantable medical devices) 3) Patients with proliferative diabetic retinopathy (except for patients with old proliferative diabetic retinopathy who do not require treatment) 4) Patients with severe diabetic neuropathy (patients whose symptoms are so severe that they seriously interfere with daily life and require assistance) 5) Patients with a New York Heart Association (NYHA) cardiac function classification of degree III or IV at evaluation within 1 year. 6) Patients who are heavy drinkers (daily consumption of 3 or more drinks is recommended) 7) Patients with a history of lactic acidosis 8) Patients with a history of severe ketosis, diabetic coma or precoma 9) Patients who have undergone surgery with general anesthesia within one month 10) Patients with severe infection or serious trauma 11) Patients with malignant tumors under treatment or within 5 years of completion of treatment 12) Patients with severe hepatic dysfunction at the time of eligibility testing (non-compensated cirrhosis or AST/ALT greater than 4 times the upper limit of normal) 13) Patients with renal dysfunction at the time of eligibility testing (estimated glomerular filtration rate [eGFR] less than 45 mL/min/1.73m2) 14) Patients who have undergone gastrectomy (not including endoscopic mucosal resection) 15) Pregnant women, lactating women, and patients who may be or plan to become pregnant 16) Patients participating in clinical research involving other interventions. 17) Patients who are judged by the principal investigator or sub-investigator to be inappropriate for t his clinical research. Exclusion criteria 12) and 13) shall be at the time of eligibility testing; otherwise, at the time of obtaining consent.

Related Information

Contact

Public contact
Name Mariko Ueda
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo. Hyogo Japan 650-0017
Telephone +81-78-382-5861
E-mail udm0520@med.kobe-u.ac.jp
Affiliation Kobe University Hospital
Scientific contact
Name Yushi Hirota
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo. Hyogo Japan 650-0017
Telephone +81-78-382-5861
E-mail hirota@med.kobe-u.ac.jp
Affiliation Kobe University Hospital