Which Medicine Works Better for Diabetes in People with Serious Kidney Disease either imeglimin or Metformin

Evaluation of safety and efficacy of Imeglimin versus Metformin in Chronic Kidney Disease Patients - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/0106556

Enrollment

Registered

2026-03-19

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N184- Chronic kidney disease, stage 4 (severe)

Interventions

Intervention1: Imeglimin: Imeglimin 1000 mg Intervention2: Imeglimin and Metformin: Imeglimin 1000mg and Metformin 500mg Intervention3: Imeglimin: 1000mg twice daily orally for 3 months Control Interv

Eligibility

Inclusion criteria

Inclusion criteria: 1. CKD Stage G4 (eGFR: 15 29 mL/min/1.73 m sq) with Type 2 DM 2. HbA1c 7 10 3. Informed consent provided

Exclusion criteria

Exclusion criteria: a. Patient on dialysis b. Kidney transplant recipients c. Acute infection d. Psychotic patient e. Critically ill patient f. Acute or chronic hepatic disease g. Severe cardiovascular instability h. Pregnancy or lactation i. Known allergy to study drugs j. HIV/HBsAg/Anti-HCV and immunocompromised patient k. Underlying malignancy

Design outcomes

Primary

Measure	Time frame
a.To assess changes in HbA1c levels after 12 weeks of therapy of study population. Timepoint: 12 weeks	—

Secondary

Measure	Time frame
a. To evaluate changes in fasting plasma glucose (FPG) and postprandial blood glucose (PPBG). b. To assess changes in serum creatinine, urea, eGFR, UACR (urine albumin creatinine ratio), serum lipid profile c. To assess serum levels of Neutrophil Gelatinase Associated Lipocalin (NGAL) & Kidney Injury Molecule (KIM-1) and to correlate with other biochemical test to assess the severity of disease d. To compare tolerability and treatment discontinuation rates Timepoint: 4,8 and 12 weeks	—

Measure

Time frame

a. To evaluate changes in fasting plasma glucose (FPG) and postprandial blood glucose (PPBG). b. To assess changes in serum creatinine, urea, eGFR, UACR (urine albumin creatinine ratio), serum lipid profile c. To assess serum levels of Neutrophil Gelatinase Associated Lipocalin (NGAL) & Kidney Injury Molecule (KIM-1) and to correlate with other biochemical test to assess the severity of disease d. To compare tolerability and treatment discontinuation rates Timepoint: 4,8 and 12 weeks

—

Countries

India

Contacts

Public ContactDr Irfan Ahmad Khan

Jawaharlal Nehru Medical College, Aligarh Muslim University

irfan1308@gmail.com9997448504

Outcome results

None listed

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