Efficacy and safety of Imeglimin add-on therapy to DPP-4 inhibitor in patients with type 2 diabetes mellitus: A randomized, double-blind, clinical trial - FAMILIAR trial

Shimoda Masashi0 个研究点目标入组 200 人开始时间: 2022年3月4日最近更新: 2024年4月23日

适应症

试验速览

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•1) Outpatients diagnosed with type 2 diabetes mellitus who are 20 years of age or older at the time of consent
•2) Patients who have been taking DPP-4 inhibitors for at least 12 weeks at the start of study treatment
•3) Patients who have been on a diet and exercise regimen for at least 12 weeks at the start of study treatment
•4)Patients with an HbA1c level between 7.0% and 9.0% on the test measured at the eligibility test
•5) Patients with an HbA1c level within 10% of the variability between the HbA1c level measured most recently at the eligibility test and the HbA1c level measured at the time of the eligibility test between 10 weeks and 4 weeks prior to the eligibility test
•6) Patients who have given written consent to participate in this study.

•1) Patients with type 1 diabetes mellitus
•2) Patients taking two or more oral hypoglycemic agents other than DPP-4 inhibitors at the time of consent
•3) Patients who have been taking an oral hypoglycaemic drug other than a DPP-4 inhibitor within 12 weeks prior to the start of study treatment
•4) Patients who have received a glucagon-like peptide receptor agonist or insulin within the last 6 months
•5) Patients with proliferative retinopathy
•6) Patients with severe diabetic neuropathy
•7) Patients with contraindications to Imeglimin
•8) Patients with impaired renal function, including patients on dialysis at the time of eligibility testing
•9) Patients with severe hepatic impairment
•10) Patients with New York Heart Association (NYHA) grade III or IV cardiac function at last evaluation within the last year
•11) Excessive and regular drinkers
•12) Pregnant women and patients who may be pregnant or lactating.
•13) Patients with malignant tumours undergoing or within 5 years of completion of treatment.
•14) Patients who are participating in a clinical study involving other interventions.
•15) Any other patients who are deemed unsuitable for this study by the principal investigator or sub-investigator.

发起方

Shimoda Masashi