Imegrimine antioxidant and renal protection

JRCT ID: jRCT1061230069

Registered date:31/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with type 2 diabetes mellitus who have not achieved good glycemic control despite treatment
• Date of first enrollment: 09/09/2023
• Target sample size: 100
• Study type: Interventional
• Intervention(s): The patients will be randomly assigned to the imeglimine and empagliflozin groups and will continue until the 24-week treatment period.

Outcome(s)

• Primary Outcome: Urinary L-FABP and 8-OHdG
• Secondary Outcome: Underlying 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 maximum: Not applicable
• Gender: Both

Include criteria

1. 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 criteria

1. 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

• Primary Sponsor: Otoda Toshiki