NIPH Clinical Trials Search

Effects of combined therapy of imeglimin and hypolipidemic agents on metabolic parameter in patients with type 2 diabetes

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Type 2 diabetes
Date of first enrollment	2023/08/01
Target sample size	100
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	The patients with type 2 diabetes are treated with imeglimin (2000 mg/day) and hypolipidemic agent (1-2 mg/day pitavastatin or 2.5-5 mg/day rosuvastatin) for 12 months The patients with type 2 diabetes are treated with imeglimin (2000 mg/day) and hypolipidemic agent (200 mg/day bezafibrate, 160 mg/day fenofibrate, 0.2 mg/day pemafibrate, 2 g/day omega-3-acid ethyl esters, or 900 mg/day icosapentoic acid ethyl ester) for 12 months

Outcome(s)

Primary Outcome	Body weight, serum lipids, and liver function marker
Secondary Outcome	Hemoglobin A1c level

Key inclusion & exclusion criteria

Age minimum	40years-old
Age maximum	80years-old
Gender	Male and Female
Include criteria
Exclude criteria	eGFR: less than 45 mL/min/1.73m2