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A Study Comparing the Effect and Safety of Imeglimin and Glimepiride in People with Type 2 Diabetes in a Tribal Area of Gujarat

A comparative evaluation of Imeglimin versus Glimepiride in patients with type 2 Diabetes Mellitus in a tribal population of Gujarat - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092573
Enrollment
170
Registered
2025-08-07
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: E11- Type 2 diabetes mellitus

Interventions

Intervention1: Imeglimin: Imeglimin 500 mg oral tablet, administered twice daily, as add-on to Metformin, for a duration of 3 months Control Intervention1: Glimepiride: Glimepiride 2 mg oral tablet, a

Sponsors

Dr Yash Pathak
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Informed consent from participants as documented by signature 2. Type 2 Diabetes Mellitus 4. HbA1c 7 to 10% 5. Patient already on metformin with uncontrolled Type 2 diabetes

Exclusion criteria

Exclusion criteria: 1. Type 1 Diabetes Patients 2. Hypersensitivity to Imeglimin, Sulfonylureas & Metformin 3. Chronic Kidney Diseases (eGFR less than 45ml/min) 4. Liver dysfunction (AST/ALT more than 3 upper limit). 5. Pregnant and lactating women 6. Corticosteroids within 3 months before enrollment or during period of study

Design outcomes

Primary

MeasureTime frame
Proportion of patients achieving HbA1c less than 7%Timepoint: 3 months—

Secondary

MeasureTime frame
possible secondary outcome - Reduced Incidence of hypoglycemic episodes.Timepoint:—

Countries

India

Contacts

Public ContactDr Suraj Tripathi

Zydus Medical College and Hospital

surajpharmacol@gmail.com9926396896

Outcome results

None listed

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