A study to evaluate the therapeutic effect of Imeglimin by comparing with existing therapy for Type 2 Diabetes Mellitus

The efficacy and safety of Imeglimin versus standard of care in Type 2 Diabetes Mellitus patients not controlled on metformin monotherapy, A Randomized controlled trial. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/060206

Enrollment

Registered

2023-11-23

Start date

Unknown

Completion date

Unknown

Last updated

2023-12-19

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: TAB IMEGLIMIN 500 MG BD PO FOR 3 MONTHS Control Intervention1: standard of care: Metformin 500 mg + Sulfonylurea ( Glimipride 1 mg ) BD ORAL FOR 3 MONTHS

Eligibility

Inclusion criteria

Inclusion criteria: 1. Type 2 Diabetes Mellitus patients not controlled on Metformin monotherapy 2. Glycemic control with Hba1c range of > 7.5 and 3. FBS >126 and 4. Type 2 Diabetes Mellitus patients of both genders 5. Type 2 Diabetes Mellitus patients of BMI 6. Type 2 Diabetes Mellitus patients with written informed consent

Exclusion criteria

Exclusion criteria: 1. Type 1 Diabetes Mellitus 2. Gestational Diabetes Mellitus 3. Liver failure and Renal failure 4. Patients with MIcro and Macro vascular complications 5. Patients with Inflammatory Bowel disease 6. Anaemic patients 7. Patients not willing to give informed consent

Design outcomes

Primary

Measure	Time frame
The efficacy of Tablet Imeglimin in Type 2 Diabetes Mellitus Patients not controlled on Metformin monotherapy with HbA1c reduction of 0.5 to 1.0 % and FBS level less than 126 mg/dlTimepoint: HbA1c reduction of 0.5 to 1.0 % at the end of 3 months and FBS level less than 126 mg/dl at the end of 3 months	—

Secondary

Measure	Time frame
Change in BMITimepoint: 3 months	—

Countries

India

Contacts

Public ContactDr Raj Kamal

Chengalpattu Medical College & Hospital

vijayapaed@gmail.com9444728805

Outcome results

None listed

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