Mechanism of Imeglimin effect on glucose metabolism by a 75g oral glucose tolerance test with double-tracer

Kaga Hideyoshi0 个研究点目标入组 25 人开始时间: 2022年2月7日最近更新: 2023年10月17日

适应症

试验速览

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•1) Patients with type 2 diabetes mellitus who are between 20 and 65 years old at the time of obtaining informed consent
•2) BMI range 18.5 kg/m2-30.0 kg/m2 at screening
•3) HbA1c level range 6.5%-10.0% at screening
•4) Patients who have not received any hypoglycemic drug other than metformin at the time of obtaining informed consent
•5) Patients who have not changed their diabetic medication (add-on, discontinuation, or dose modification) within 12 weeks prior to obtaining informed consent
•6) Patients who have voluntarily provided written informed consent on the basis of proper understanding of sufficient explanations given before participation in this study

•1) Patients with type 1 diabetes mellitus
•2) Patients with contraindications to Imeglimin
•3) Patients with severe liver disease (e.g., decompensated hepatic cirrhosis ) or AST or ALT greater than 100 IU/L at screening
•4) Patients with renal disease or with an estimated glomerular filtration rate (eGFR) of less than 45 mL/min/1.73m2 at screening
•5) Patients with serious cardiac disease (e.g., cardiac failure, unstable angina pectoris) or who have had a myocardial infarction or angina attack within 24 weeks prior to obtaining informed consent
•6) Patients who have had a stroke attack (cerebral infarction, cerebral hemorrhage) within 24 weeks prior to obtaining informed consent
•7) Patients with malignancy
•8) Patients with severe diabetic complications (neuropathy, retinopathy, nephropathy)
•9) Patients in severe ketosis, diabetic coma, or precoma
•10) Patients with endocrine disorders (e.g., pituitary, thyroid, adrenal) inadequately treated with hormone replacement therapy, etc.
•11) Patients with moderate or severe anemia (hemoglobin (Hb) less than 9.5 g/dL)
•12) Patients who are heavy drinkers (average daily alcohol consumption of more than 3 glasses (one glass: 180 ml) of sake or 3 large beer bottles)
•13) Patients who are pregnant, lactating or have the possibility of pregnancy during the study period
•14) Other patients deemed inappropriate by the principal investigator or sub-investigator

发起方

Kaga Hideyoshi