Comparison of Effectiveness and Safety of Imeglimin and Metformin monotherapy in type 2 Diabetes: A Study

Comparison of Effectiveness and Safety of Imeglimin and Metformin monotherapy in type 2 Diabetes Mellitus: A Randomised Open Label Parallel Group Phase IV Controlled Trial - Nil

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/056584

Enrollment

Registered

2023-08-17

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

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: 1000 mg twice daily Orally for 16 weeks Control Intervention1: Metformin: 1000 mg twice daily

Eligibility

Inclusion criteria

Inclusion criteria: Newly Diagnosed cases with Type 2 Diabetes Mellitus HbA1c >7.5% and <9%

Exclusion criteria

Exclusion criteria: Female patient who are pregnant and lactating Patients on any other glucose lowering agent Establised Cardiovascular disease, Compromised renal Function(eGFR 3 ULN) and psychiatric illness

Design outcomes

Primary

Measure	Time frame
Change of HBA1c at week 16th with respect to week 0Timepoint: Change of HBA1c at week 16th with respect to week 0	—

Secondary

Measure	Time frame
Change in FPG & PPPG Adverse reaction Adherence to medicationTimepoint: Week 8,12,16	—

Countries

India

Contacts

Public ContactDr Arjun Baidya

NRS Medical College and Hospital

arjun.baidya@gmail.com6351239897

Outcome results

None listed

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