Comparative evaluation of clinical markers indicating hypoglycaemia treated with ImeglimiN and its eFfect on erythrocytes IN patIents with TYpe 2 diabetes - INFINITY study

Osonoi Takeshi0 sites30 target enrollmentDecember 5, 2022

Overview

No summary available.

Registry

who.int

Start Date

December 5, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Osonoi Takeshi

•Patients who meet all of the following criteria are included in this study;
•1\) patients with type 2 diabetes mellitus who are treated only with diet therapy and exercise therapy, alpha\-glucosidase inhibitor combined with diet therapy and exercise therapy, metformin combined with diet therapy and exercise therapy, or both alpha\-glucosidase inhibitor and metformin combined with diet therapy and exercise therapy
•2\) Male who are aged of 20 years or older, or postmenopausal female
•3\) patients whose HbA1c is more than 6\.5% and 8\.5% or less at giving their consent
•4\) patients who did not change the dose or usage of anti\-diabetic agents within 4 weeks before giving their consent
•5\) patients who provide their consent to participate in this study in a written form by themselves after full explanation of this study

•Patients who fall into any of the following criteria at the consent date are excluded from participating in the study;
•1\) patients who use any anti\-diabetic agents other than alpha\-glucosidase inhibitor and metformin
•2\) patients with anemia (male \< 13 g/dL, female \< 12g/dL)
•3\) patients with hypoalbuminemia (\< 30\.mg/dL)
•4\) patients with thyroid dysfunction
•5\) patients with hepatic cirrhosis
•6\) patients with nephrotic syndrome or mild or severe renal dysfunction (eGFR \< 45mL/min/1\.73m2\)
•7\) patients who are treated with antiplatelet agents or antithrombotic agents
•8\) patients who are diagnosed as malignant tumor
•9\) patients who need regal representatives