A study to evaluate the effects of imeglimin on blood sugar control and overall health in people with type 2 diabetes.

Pharmacometabolomics of Imeglimin Therapy in Type 2 Diabetes Mellitus: A Randomized Controlled Trial on Clinical Outcomes and Mechanistic Insights - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/02/103121

Enrollment

Registered

2026-02-05

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

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: Imeglimin hydrochloride will be administered orally at a dose of 1000 mg twice daily for a duration of 12 weeks. The drug will be given in tablet form and administered with m

Eligibility

Inclusion criteria

Inclusion criteria: Adults aged 18 to 65 years with a newly diagnosed of T2DM HbaA1c greater than 6.5 percentage FBS greater than 126 mg per dL BMI 18.5 to 30 kg per meter square Patients willing to give informed consent and comply with study visits

Exclusion criteria

Exclusion criteria: Type 1 Diabetes mellitus Patients taking insulin therapy or recent oral hypoglycaemic agents (greater than 3 months) Significant hepatic impairment Renal disease Active infection Malignancy Pregnancy Breast feeding

Design outcomes

Primary

Measure	Time frame
Change in plasma metabolomic profile from baseline to post treatment in patients receiving imeglimin therapy and its association with glycaemic response assessed using untargeted pharmacometabolomic analysis. Change in glycaemic parameters from baseline to the end of the treatment period assessed by HbA1c (percentage) Fasting blood glucose (mg per dL) Safety of imeglimin therapy assessed by the incidence and nature of adverse drug reactions and changes in laboratory safety parameters during the study period.Timepoint: 3 months	—

Measure

Time frame

Change in plasma metabolomic profile from baseline to post treatment in patients receiving imeglimin therapy and its association with glycaemic response assessed using untargeted pharmacometabolomic analysis. Change in glycaemic parameters from baseline to the end of the treatment period assessed by HbA1c (percentage) Fasting blood glucose (mg per dL) Safety of imeglimin therapy assessed by the incidence and nature of adverse drug reactions and changes in laboratory safety parameters during the study period.Timepoint: 3 months

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Secondary

Measure	Time frame
To evaluate changes in plasma metabolomic profiles following imeglimin therapy from baseline to 3 months using untargeted pharmacometabolomic analysis. To identify metabolic pathways and biomarkers associated with glycaemic response to imeglimin therapy. To compare metabolomic signatures between patients receiving imeglimin and those receiving metformin at the end of the study period. To assess changes in anthropometric parameters, including waist hip ratio and waist to height ratio, from baseline to 3 months. To evaluate changes in biochemical parameters, including lipid profile, liver function tests, and renal function tests. To assess the safety and tolerability of imeglimin by monitoring adverse drug reactions during the study period. To assess medication adherence and lifestyle modification among patients in both study groups over the treatment duration.Timepoint: 3 months	—

Measure

Time frame

To evaluate changes in plasma metabolomic profiles following imeglimin therapy from baseline to 3 months using untargeted pharmacometabolomic analysis. To identify metabolic pathways and biomarkers associated with glycaemic response to imeglimin therapy. To compare metabolomic signatures between patients receiving imeglimin and those receiving metformin at the end of the study period. To assess changes in anthropometric parameters, including waist hip ratio and waist to height ratio, from baseline to 3 months. To evaluate changes in biochemical parameters, including lipid profile, liver function tests, and renal function tests. To assess the safety and tolerability of imeglimin by monitoring adverse drug reactions during the study period. To assess medication adherence and lifestyle modification among patients in both study groups over the treatment duration.Timepoint: 3 months

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Countries

India

Contacts

Public ContactDr J S Kumar

SRM College of Pharmacy SRMIST Kattankulathur 603203

sarumats@srmist.edu.in7010530419

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026