A Study on the Effect of Adding Imeglimin to Existing Treatment on HbA1c Reduction in Adults with Uncontrolled Type 2 Diabetes.

Study of Outcomes with Use of Novel Drug in Diabetes: Effectiveness of Imeglimin in the Uncontrolled Diabetes in South Indian population - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/06/089609

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 500 Mg for two times a day from Baseline to 6 months. Control Intervention1: Not Applicable: Not Applicable

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed Type 2 Diabetes Mellitus for more than 1 year HbA1c greater than 7.5 percentage despite stable antidiabetic therapy for 3 months and more Willing to provide written informed consent

Exclusion criteria

Exclusion criteria: Type 1 diabetes or other specific types of diabetes Chronic Kidney Disease Patient or hepatic dysfunction Recent cardiovascular event within 6 months Pregnant or lactating women Known hypersensitivity to Imeglimin

Design outcomes

Primary

Measure	Time frame
Change in Glycated Hemoglobin HbA1cTimepoint: 3 month and 6 month	—

Secondary

Measure	Time frame
Change in Body Weight and Body Mass Index (BMI)Timepoint: 1 month, 3 month and 6 month;Change in Lipid Profile (Total Cholesterol, LDL, HDL, Triglycerides)Timepoint: 3 month and 6 month;Incidence, type, and causality of Adverse Drug Reactions (ADRs)Timepoint: Monitored Everyday via tele calling.;Change in Fasting Plasma Glucose (FPG) and Postprandial Blood Sugar (PPBS)Timepoint: Month 1,Month 3 and 6 month	—

Measure

Time frame

Change in Body Weight and Body Mass Index (BMI)Timepoint: 1 month, 3 month and 6 month;Change in Lipid Profile (Total Cholesterol, LDL, HDL, Triglycerides)Timepoint: 3 month and 6 month;Incidence, type, and causality of Adverse Drug Reactions (ADRs)Timepoint: Monitored Everyday via tele calling.;Change in Fasting Plasma Glucose (FPG) and Postprandial Blood Sugar (PPBS)Timepoint: Month 1,Month 3 and 6 month

—

Countries

India

Contacts

Public ContactDR HARIHARAN SUKUMARAN

Tambaram Medical Center and Research Institute (TMCRI Pvt.Ltd)

crchead@tambarammedicalcenter.com6383346130

Outcome results

None listed

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