Effect of Switching from Metformin-Based Therapy to Imeglimin Combination on Blood Sugar Control in Adults with Uncontrolled Type 2 Diabetes

Study on Performance of Imeglimin versus Conventional Combination Therapy in Uncontrolled Type 2 Diabetes Mellitus A Real-World Evaluation - SPICE -DM

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/06/089610

Enrollment

Registered

2025-06-26

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-21

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 500 Mg: Imeglimin 500mg two times a day from basetime to 6 months. Control Intervention1: Not Applicable: Not Applicable

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed with T2DM, on metformin-based dual or Triple therapy for 6 months and more HbA1c greater than 7.5 percentage Willingness to provide informed consent

Exclusion criteria

Exclusion criteria: Type 1 Diabetes Mellitus Chronic Kidney Disease Hepatic dysfunction Pregnancy or lactation Known hypersensitivity to imeglimin Patients in ICU

Design outcomes

Primary

Measure	Time frame
Change in HbA1CTimepoint: At 3 Month and 6 Month	—

Secondary

Measure	Time frame
Change in Body Mass Index (BMI) & Weight.Timepoint: At Month 1, Month 3 & Month 6.;Change in Lipid ProfileTimepoint: At 3 Month & 6 Month.;Incidence & nature of Adverse Drug Reactions (based on Naranjo Scale)Timepoint: Continuous monitoring from Baseline to Month 6 via Telecalling.	—

Countries

India

Contacts

Public ContactDR HARIHARAN SUKUMARAN

Tambaram Medical Center (TMCRI Pvt.Ltd)

crchead@tambarammedicalcenter.com6383346130

Outcome results

None listed

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