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A phase 4, 52-week, open-label, long-term study of imeglimin in Japanese type 2 diabetic patients with renal impairment

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

Yamamoto Koshi

Sumitomo Pharma Co., Ltd.

6-8, Doshomachi 2-chome,Chuo-ku,Osaka,Osaka 541-0045,Japan

cr@sumitomo-pharma.co.jp

Product information center

Sumitomo Pharma Co., Ltd.

6-8, Doshomachi 2-chome,Chuo-ku,Osaka,Osaka 541-0045,Japan

+81-120-034-389

cc@sumitomo-pharma.co.jp

Complete

Dec. 23, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

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

Both

Type 2 Diabetes

Imeglimin hydrochloride 500 mg twice daily or imeglimin hydrochloride 500 mg once daily

Adverse Reaction

+81-52-611-6261

Dec. 07, 2021

No

none