Study of efficacy and side effects of imeglimin as an antidiabetic agent as single drug or as an add on drug

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 - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/065835

Enrollment

200

Registered

2024-04-16

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Imeglimin: The drug will be given in a dose of 1000 mg twice a day orally for a period of 6 months. Control Intervention1: NOT APPLICABLE: NOT APPLICABLE

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
HBa1c reduction and adeverse effectsTimepoint: 3 months and 6 months	—

Secondary

Measure	Time frame
Lipid profile reductionTimepoint: 3 months and 6 months	—

Countries

India

Contacts

Public ContactAbhinav Garg

Adesh institute of medical sciences and research

abhinavgarg24@yahoo.co.in7888993130

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026