Effectiveness and Safety of the drug Remogliflozin in diabetic patients with fat accumulation in liver

Efficacy and Safety of Remogliflozin on Non-alcoholic fatty liver disease in diabetic patients on background Metformin therapy-A Randomized Controlled Clinical Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/02/023250

Enrollment

Registered

2020-02-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified

Interventions

Intervention1: Tablet Remogliflozin Etabonate: Dose 100 mg Twice daily Oral route 6 week duration Intervention2: Tablet Metformin: Dose 500 mg Twice daily Oral route 6 weeks duration Control Intervent

Eligibility

Inclusion criteria

Inclusion criteria: Controlled Type 2 Diabetes Mellitus on Metformin therapy Diagnosed with Non-Alcoholic Fatty liver disease Fasting plasma glucose less than than 250 mg/dl Willing to participate in the study and comply with it procedures by signing a written informed consent

Exclusion criteria

Exclusion criteria: age less than 18 years and more than 75 years Uncontrolled Diabetes Mellitus Diabetic patients on Insulin therapy Fasting plasma glucose more than 250 mg/dl Viral Hepatitis Autoimmune Hepatitis Primary Billiary Cirrhosis

Design outcomes

Primary

Measure	Time frame
Aspartate transaminase Alanine TransaminaseTimepoint: 0 week and 6 weeks 0 week and 6 weeks	—

Secondary

Measure	Time frame
Adverse drug reactionsTimepoint: 6 weeks;Body weightTimepoint: 0 week and 6 weeks;Fasting blood glucoseTimepoint: 0 week and 6 weeks	—

Countries

India

Contacts

Public ContactR Jamuna Rani

SRM MCH and RC

melvingeorge2003@gmail.com9894133697

Outcome results

None listed

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