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
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- HBa1c reduction and adeverse effects
研究概览
简要总结
After screening, all participants will receive 1000mg Imeglimin twice a day for 24 weeks either as monotherapy in treatment naïve patients or as combination therapy in those who are already receiving oral antidiabetic therapy. Patients will be assessed(physical examination, vital signs, efficacy and safety assessments) at week 12 and 24 after starting the treatment.
In case of combination therapy-
metformin (500- 2500 mg) + vildagliptin (50-100 mg) or,
metformin (500- 2500 mg) + dapagliflozin (5- 10 mg) or ,
metformin (500- 2500 mg) + glimepride (1- 8 mg) or,
metformin (500- 2500 mg) + sitagliptin (50- 100 mg) or,
metformin (500- 2500 mg) + glimepride (1- 8 mg) + pioglitazone (15 mg)
or any other combination.
Above combinations will be used as combination therapy and Imeglimin 1000mg as add on antidiabetic agent will be used.
Patients with unacceptable hyperglycemia (i.e. fasting plasma glucose >250 mg/dl from baseline to week 4 or any HBA1C of at least 10.5% for long term monotherapy group and >10.5% for long term combination therapy) should discontinue the study drug and a rescue therapy will be initiated. The initiation, choice and dose of rescue medication used will be at the discretion of the physician, according to the local prescribing information, but insulin will not be used. Any increase in the dosing of background antidiabetic therapy will be considered as a rescue medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •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/1.73m
- •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.
排除标准
- •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.
结局指标
主要结局
HBa1c reduction and adeverse effects
时间窗: 3 months and 6 months
次要结局
- Lipid profile reduction(3 months and 6 months)
研究者
Abhinav Garg
Adesh institute of medical sciences and research