Comparing the efficacy and safety of imeglimin versus sitagliptin as add-ons to metformin in patients not acheiving glycemic control on metformin.

Efficacy and safety of Imeglimin versus Sitagliptin as add-on therapy in type 2 Diabetes Mellitus patients not achieving glycaemic control on metformin: An open label, single centre randomized controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/063813

Enrollment

100

Registered

2024-03-07

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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: Tab Imeglimin 500 mg BD: Tab Imeglimin 500 mg BD + Tab Metformin 2000mg/day or maximum tolerated dose for 6 months Control Intervention1: Tab Sitagliptin 50 mg OD: Tab Sitagliptin 50 mg

Eligibility

Inclusion criteria

Inclusion criteria: Type 2 diabetes patients uncontrolled on maximum tolerated metformin therapy or maximum dose more than 2000mg/day and life style modification for at least 12 weeks and HbA1c between 7 and 10% Drug-naive type 2 diabetes patients requiring dual antidiabetics with HbA1c more than 7.5% Patients willing to give written informed consent

Exclusion criteria

Exclusion criteria: 1. Patient on anti-diabetics (oral or injectable) other than metformin 2. Heart failure (NYHA class III and IV) 3. Any major cardiovascular or cerebrovascular event in 24 weeks prior to screening 4. Known case of chronic liver disease or cirrhosis or SGOT/SGPT values more than two times the upper normal limit (more than 35 IU/L for SGOT and more than 45 IU/L for SGPT) 5. Impaired renal function with eGFR less than 60ml/min/1.73m2 6. Known case of bullous skin diseases 7. Pregnant and lactating women 8. Known history of allergy to Sitagliptin or Imeglimin 9. Patients taking herbal medications

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of Imeglimin versus Sitagliptin group as add-on therapy using HbA1c and fasting blood glucose levelsTimepoint: 0, 1, 2, 3 and 6 months	—

Secondary

Measure	Time frame
To compare the Triglyceride Glucose Index (TyG) in Imeglimin versus Sitagliptin groupTimepoint: 0, 3, 6 months;To compare the need for dose escalation and rescue medication in Imeglimin versus Sitagliptin groupTimepoint: 1, 2, 3 and 6 months;To assess and compare the incidence of adverse events in Imeglimin versus Sitagliptin groupTimepoint: 1, 2, 3 and 6 months	—

Countries

India

Contacts

Public ContactDr Kriti Kalra

AIIMS, Bathinda

kwatragagandeep@gmail.com9815588600

Outcome results

None listed

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