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Comparison of Dapagliflozin and Pioglitazone for Non-Alcoholic Fatty Liver Disease in Type 2 Diabetes

A Comparitive study of Dapagliflozin Vs Pioglitazone in Patients of Non Alcoholic Fatty liver disease with Type 2 Diabetes Mellitus - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/071087
Enrollment
108
Registered
2024-07-23
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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 Health Condition 2: E116- Type 2 diabetes mellitus with other specified complications

Interventions

Intervention1: DAPAGLIFLOZIN: An inhibitor of sodium glucose co transporter 2, and is responsible for reducing renal tubular glucose reabsorption. DOSE : 10 mg/day OD Control Intervention1: PIOGLITAZ

Sponsors

Babra
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 NAFLD Fibrosis Score(Stage 1 to Stage 3) 2 USG (Grade 2 & Grade 3 fatty liver) 3 HbA1C 6.5% & above 4 BMI 23 kg/m² & above 5 Type 2 diabetes mellitus patient on treatment of metformin (upto 2g/day)

Exclusion criteria

Exclusion criteria: 1 Patient with heart failure, kidney failure, malignancy 2 Pregnant & Lactating mothers 3 Habitual drinkers 4 Contraindication to dapagliflozin and pioglitazone 5 Use of steroid &/ or other immunosuppressor 6 H/o mental illness or inability to co operate

Design outcomes

Primary

MeasureTime frame
Achieving the target level of HbA1C 6.5% Timepoint: 3 week 6 week 12 week

Secondary

MeasureTime frame
Secondary Outcome: • Assessment of glycemic control (HbA1c) in participants. • Adverse events of Dapagliflozin and Pioglitazone in study population. Timepoint: 3,6,12th week

Countries

India

Contacts

Public ContactBabra

Eras Lucknow Medical College

fardan.lko@gmail.com9936671891

Outcome results

None listed

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