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

Not Applicable

Recruiting

• Conditions: Type 2 diabetes mellitus; D003924

• Registration Number: JPRN-jRCTs031220489
• Lead Sponsor: Osonoi Takeshi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-05
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

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
10) patients who have history of hypersensitivity against content of imeglimin
11) patients who are contraindicated to imeglimin
12) patients with other conditions that the investigator thinks inappropriate for the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of hemoglobin concentration from baseline to month 6 of imeglimin administration