An open-label, long-term study of imeglimin in type 2 diabetic patients with renal impairment

JRCT ID: jRCT2041210115

Registered date:23/12/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Type 2 Diabetes
• Date of first enrollment: 23/12/2021
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Imeglimin hydrochloride 500 mg twice daily or imeglimin hydrochloride 500 mg once daily

Outcome(s)

• Primary Outcome: Adverse Reaction

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Patient with type 2 diabetes mellitus diagnosed at least 8 weeks prior to screening who are either of the followings:
a)Patients who have not received any drug therapy for type 2 diabetes mellitus for at least 8 weeks before screening
b)Patients on a drug therapy solely with 1 hypoglycemic agent except for insulin formulation for at least 8 weeks before screening
2)Patients with eGFR < 45 mL/min/1.73 m2 at screening
3)Patients with HbA1c >= 6.5% and < 10.0% at screening
4)Female patients of childbearing potential must have a negative serum pregnancy test at screening
5)Patients who agree to practice appropriate contraception to prevent pregnancy of themselves or their female partners, if the patients or their female partners are of childbearing potential

Exclude criteria

1)Patients who were diagnosed as diabetes mellitus classified as other than type 2 diabetes mellitus
2)Patients who have history of diabetic ketoacidosis or hyperosmolar non-ketoic coma
3)Patients who were diagnosed as cardiovascular disorder, such as, myocardial infraction, stroke, unstable angina, etc.
4)Patients with uncontrolled high blood pressure
5)Patients with severe hepatic impairment
6)Dialysis patients, patients with a history of nephrectomy or renal transplant
7)Female patients who are patients, suspected to be pregnant, or breastfeeding
8)Patients who have received imeglimin hydrochloride in the past
9)Patients who are, in the discretion of the investigator, inappropriate to participate in the study

Related Information

• Primary Sponsor: Yamamoto Koshi