Study of efficacy and side effects of imeglimin as an antidiabetic agent as single drug or as an add on drug
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2024/04/065835
- Lead Sponsor
- Abhinav Garg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HBa1c reduction and adeverse effectsTimepoint: 3 months and 6 months
- Secondary Outcome Measures
Name Time Method ipid profile reductionTimepoint: 3 months and 6 months