Effect on blood glucose fluctuation after addition of imeglimin in patients with type 2 diabetes mellitus under pre-administration of metformin

Effect on blood glucose fluctuation after addition of imeglimin in patients with type 2 diabetes mellitus under pre-administration of metformin - Effect on blood glucose fluctuation after addition of imeglimin in patients with type 2 diabetes mellitus under pre-administration of metformin

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000051451

Enrollment

Registered

2023-06-26

Start date

2023-01-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

Imeglimin group within the group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Type 2 diabetes who have inadequate glycemic control(HbA1c between 7.0 and 12.4 %) under medical treatment by dieting and exercise cure and/or drug treatment. 2)Over 20 years old and less than 80 years old 3)Sex unquestioned 4)No treatment or treatment with stable doses of antihypertensive and antiplatelet agents for at least 3 months prior to randomization. 5)The patient who gives a written informed

Exclusion criteria

Exclusion criteria: 1)Type 1 diabetes 2)Liver dysfunction (hepatic enzymes more than three times the upper limit of normal ranges) 3)A pregnant woman and/or a woman under breast-feeding 4)Impaired kidney function (serum crearinine greater than 1.3 mg/dl in men, 1.2 mg/dl in women) 5)Diabetic proliferative retinopathy 6)The patients who has an anamnesis of hypersensitivity to the ingredient of a trial drug 7)Patient with intolerance of medical reasons by doctor.

Design outcomes

Primary

Measure	Time frame
Blood glucose fluctuation by CGM (Continuous Glucose Monitoring System) TIR(Time in range) TAR(Time above range) TBR(Time below range)	—

Secondary

Measure	Time frame
Blood glucose fluctuation(Blood glucose,GMI,SD,CV,MAGE,CONGA2,MODD,Mvalue) HbA1c,Body weight BMI,Fasting blood glucose Fasting CPR	—

Countries

Japan

Contacts

Public ContactTeruo Jojima

Dokkyo Medical University Department of Endocrinology and Metabolism

jojima@dokkyomed.ac.jp0282872150

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026