A diabetic study to find the safety and efficacy of newer drug Imeglimin.

A Comparative study to Evaluate the Efficacy and Safety of Imeglimin with Metformin versus Metformin in Type 2 Diabetes Mellitus patients in a tertiary care hospital,Chengalpattu-A Randomised Controlled Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/06/053822

Enrollment

140

Registered

2023-06-13

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

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: 1000mg for 3 months twice daily Control Intervention1: Placebo: Same as the Original drug

Eligibility

Inclusion criteria

Inclusion criteria: 1)Male & Female population 2)HbA1c >6.5 and 3)Patients willing to participate and given written informed consent

Exclusion criteria

Exclusion criteria: 1)Those who are on insulin therapy or any injectable glucose lowering drugs in the past 30 days. 2)Pregnant and lactating mother 3)Patients with impaired hepatic or renal function 4)Patients with hypertension,congestive cardiac failure,ischemic heart disease. 5)Clinically significant micro vascular and macro vascular complications 6)Patients who didn’t give written informed consent.

Design outcomes

Primary

Measure	Time frame
To estimate the primary efficacy outcome change of HbA1c levelTimepoint: 3 months	—

Secondary

Measure	Time frame
To determine the changes in baseline fasting plasma glucose and pro insulin/insulin ratioTimepoint: 3 months	—

Countries

India

Contacts

Public ContactDr Shaki Sam

Karpaga Vinayaga Institute of Medical sciences & Research Centre

prathap.thap@gmail.com9600283380

Outcome results

None listed

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