To study the efficacy and safety of imeglimin as monotherapy or as an add on therapy with existing antidiabetic agents in North Indian population with type 2 diabetes - NI

Abhinav Garg0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月29日

试验速览

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•Patients who are 18 years or older with type 2 diabetes with diet/exercise alone or together with a single or combination antidiabetic therapy will be enrolled in this 24 weeks study.
•Inclusion criteria for the patients who will receive imeglimin monotherapy includes: Patients who were treated with diet and exercise without an antihyperglycaemic agent during at least 12 weeks prior to screening. Hba1c of 7.0%-10.5%, and an estimated glomerular filtration rate(as per MDRD equation) greater than or equal to 50 ml/min/1.73m2.
•Inclusion criteria for the patients who will receive imeglimin add on therapy includes: Patients who were treated with diet and exercise plus treatment with an antihyperglycaemic agent that are alpha-glucosidase inhibitors(AGI), biguanide(BIG), dipeptidyl peptidase-4 inhibitors(DPP4-I), glinide(GLIN), injectable glucagon-like inhibitor(GLP1-RA), Sodium-glucose co-transporter inhibitor(SGLT2-I), sulphonylurea(SU), or thiazolidinedione(TZD), will be included in the long term combination therapy. Type, dose and regimen of background antidiabetic therapy will be unchanged for at least 12 weeks prior to screening. Hba1c of 7%-10.5%, and an estimated glomerular filteration rate(as per MDRD equation) greater than or equal to 50 ml/min/1.73m2.

•Pregnant and lactating women,Cirrhosis- CTP class C, Insulin therapy 30 days prior to screening.
•Heart failure-NYHA class III or IV and acute coronary events or cerebrovascular event 24 weeks before screening

发起方

Abhinav Garg