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A clinical trial to compare the effectiveness of anti diabetic drug Dapagliflozin to that of Saroglitazar, a drug used in diabetic lipid (fat) disorders on the fat accumulation & scarring i.e. fibrosis of the liver in patients of type 2 diabetes mellitus with non-alcoholic fatty liver disease.

Efficacy of Dapagliflozin vs Saroglitazar on hepatic steatosis & fibrosis in patients of type 2 diabetes mellitus with non-alcoholic fatty liver disease: A pilot randomised controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/053723
Enrollment
110
Registered
2023-06-09
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Health Condition 1: E11- Type 2 diabetes mellitus Health Condition 2: E116- Type 2 diabetes mellitus with other specified complications

Interventions

Intervention1: DAPAGLIFLOZIN: 10 mg once daily orally for a period of 12 months Intervention2: Dapagliflozin and Saroglitazar: Efficacyof Dapagliflozin and Saroglitazar on hepatic steatosis and fibros

Sponsors

Dr Bijay Ketan Das
Lead Sponsor
Dr Preetam Nath
Collaborator
Dr Sambit Das
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: All patients meeting the diagnostic criteria for type 2 diabetes mellitus with non-alcoholic fatty liver disease

Exclusion criteria

Exclusion criteria: Patients with HbA1c > 9% Patients with prior treatment with pioglitazone, saroglitazar or dapaglifzolin , VIT E, UDCA and obeticholic acid or agents known to induce steatosis (like valproate, amiodarone, oc pills or methotrexate) in the Past 6 months.

Design outcomes

Primary

MeasureTime frame
Change in the CAP (controlled attenuated parameter) & LSM (liver stiffness measurement)Timepoint: Baseline 12 weeks 24 weeks 52 weeks—

Secondary

MeasureTime frame
Change in weight, BMI & waist circumferenceTimepoint: Baseline 12 weeks 24 weeks 52 weeks;Changes in the metabolic parameter (fasting lipid profile, fasting plasma glucose, 2hr post prandial blood sugar, HbA1c )Timepoint: Baseline 12 weeks 24 weeks 52 weeks;Changes in the NAFLD fibrosis scores & FIB-4 scores.Timepoint: Baseline 12 weeks 24 weeks 52 weeks—

Countries

India

Contacts

Public ContactBijay Ketan Das

Kalinga Institute Of Medical Sciences, Bhubaneswar, Odisha

drsambitendocrine@gmail.com8093060177

Outcome results

None listed

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