NIPH Clinical Trials Search

JRCT ID: jRCT1061230069

Registered date:31/10/2023

Imegrimine antioxidant and renal protection

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedPatients with type 2 diabetes mellitus who have not achieved good glycemic control despite treatment
Date of first enrollment09/09/2023
Target sample size100
Countries of recruitment
Study typeInterventional
Intervention(s)The patients will be randomly assigned to the imeglimine and empagliflozin groups and will continue until the 24-week treatment period.


Primary OutcomeUrinary L-FABP and 8-OHdG
Secondary OutcomeUnderlying disease, age, sex, height, weight, abdominal circumference, blood pressure, pulse pressure, pulse, BMI, blood count, liver function, renal function, lipids, uric acid, HbA1c level, ABI/baPWV (pulse wave velocity), oxidative stress markers (BAP/d-ROMs)

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Include criteria1. age at the time of consent, 20 years or older 2. HbA1c > 6.5% within 8 weeks prior to study drug initiation 3. diet and exercise alone for at least 12 weeks prior to study entry, or taking any single agent (SU, glinide, BG, alpha-GI, TZD, DPP4 inhibitor) at the same dose for at least 12 weeks prior to study entry 4. gender: any gender 5. inpatient or outpatient: outpatient 6. Patients who can take Imeglimine or Empagliflozin for more than 24 weeks.
Exclude criteria1. patients with hypersensitivity to any component of the study drug 2. patients with type 1 diabetes mellitus, diabetes mellitus due to other specific mechanisms or diseases, impaired glucose tolerance, or gestational diabetes mellitus 3. patients with pre-existing or complicated diabetic ketoacidosis 4. Patients treated with the study drug within 12 weeks prior to screening 5. Patients treated with insulin therapy within 12 weeks prior to screening 6. 6. Patients taking steroids, non-steroidal anti-inflammatory drugs, or antibiotics 7. 7. patients with poorly controlled or unstable diabetes mellitus (HbA1c level increase >3% in the 12 weeks prior to screening) 8. patients with various concomitant inflammatory autoimmune diseases 9. patients with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 or hemodialysis patients 10. patients with infectious complications 11. pregnant or lactating patients 12. Patients who are judged by the investigator or subinvestigator to be ineligible for this study.

Related Information


Public contact
Name Toshiki Otoda
Address 3-18-15, Kuramoto-cho, Tokushima, 770-8503, Japan Tokushima Japan 770-8503
Telephone +81-88-633-7120
Affiliation Tokushima University
Scientific contact
Name Toshiki Otoda
Address 6-1, Kawahara, Takarada-cho, Anan City, Tokushima, 774-0045, Japan Tokushima Japan 770-0045
Telephone +81-88-633-7120
Affiliation Anan Medical Center