臨床研究等提出・公開システム

Japanese

Date of registration	Oct. 31, 2023
Last modified on	Oct. 31, 2023
Trial ID	jRCT1061230069

Scientific Title	Antioxidant and renoprotective effects of Imegrimine
Public Title	Imegrimine antioxidant and renal protection

Contact for Scientific Queries	Name	Otoda Toshiki
	Affiliation	Anan Medical Center
	Address	6-1, Kawahara, Takarada-cho, Anan City, Tokushima, 774-0045, Japan
	Telephone	+81-88-633-7120
	E-mail	otoda.toshiki@tokushima-u.ac.jp
Contact for Public Queries	Name	Otoda Toshiki
	Affiliation	Tokushima University
	Address	3-18-15, Kuramoto-cho, Tokushima, 770-8503, Japan
	Telephone	+81-88-633-7120
	E-mail	otoda.toshiki@tokushima-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Sept. 04, 2023
Actual date of first enrollment		Sept. 09, 2023
Target sample size		100
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion 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.
	Exclusion 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.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Patients with type 2 diabetes mellitus who have not achieved good glycemic control despite treatment
Intervention(s)		The patients will be randomly assigned to the imeglimine and empagliflozin groups and will continue until the 24-week treatment period.
Health Condition(s) Keyword		Type 2 diabetes
Intervention(s) Keyword		randomized controlled trial
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Urinary L-FABP and 8-OHdG
Secondary Outcome(s)		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)

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Anan Medical Center Clinical Research Ethics Review Committee
Address	6-1, Kawahara, Takarada-cho, Anan City, Tokushima, 774-0045, Japan, Tokushima
Telephone	+81-884-28-7777
E-Mail	totoko4006@me.com
Approval Status	Approval
Date of approval	Sept. 12, 2023

Name of Certified Review Board	Tamaki Aozora Hospital Life Science and Medical Research Ethics Review Committee
Address	56-1, Kitakashiya, Aza Hayabuchi, Kokufu-cho, Tokushima, 779-3125, Japan, Tokushima
Telephone	+81-88-642-5050
E-Mail	y.watanabe@tamaki-aozora.ne.jp
Approval Status	Approval
Date of approval	Sept. 12, 2023

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none