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Can the Combination of Dapagliflozin and Pioglitazone in Non Alcoholic Fatty Liver Disease with Type2 Diabetes Mellitus patients will have similar effect as Dapagliflozin or Pioglitazone alone?

A Comparative study on the effect of Dapagliflozin, Pioglitazone and a combination of Dapagliflozin and Pioglitazone in Non Alcoholic Fatty Lliver Disease patients with Type 2 Diabetes Mellitus - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/082781
Enrollment
90
Registered
2025-03-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: K742- Hepatic fibrosis with hepatic sclerosis

Interventions

Intervention1: DAPAGLIFLOZIN and PIOGLITAZONE: patients of non alcoholic fatty live disease with type 2 diabetes will be divided into 3 groups by randomisation. After randomisation, one study group w

Sponsors

BOLISETTY TULASI DEVI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: presence of fatty liver on ultrasound with deranged liver enzymes who are known cases of non alcoholic fatty liver disease spectrum with type 2DM and HbA1c of more than 6.5

Exclusion criteria

Exclusion criteria: patients of chronic or viral hepatitis B or C infection, significant alcohol intake of more than 30g in males and 20g per day in females after converting to ethanol, cases with history of hepatotoxic drugs, drugs leading to hepatic fibrosis or drugs supposed to decrease hepatic fibrosis like omega 3 fatty acids, vitamin E, UDCA, saroglitazar, pioglitazone, GLP1 agonists, documented cases of autoimmune hepatitis, hepatic storage or hereditary diseases, Wilsons, hemochromatosis will be excluded. patients with severe renal dysfunction, ischemic heart disease, heart failure with NYHA grade 3 at present or past, complicated UTI or pyelonephritis, Pregnant and lactating females will be excluded

Design outcomes

Primary

MeasureTime frame
Liver stiffness measurement score by Transient elastography, SGOT, SGPT, TPC, APRI, FIB 4, NAFLD FIBROSIS SCORETimepoint: once before initiating the drug and once after completion of 3 months course

Secondary

MeasureTime frame
HbA1cTimepoint: 3 months

Countries

India

Contacts

Public ContactDr Bolisetty Tulasi Devi

IMS AND SUM HOSPITAL

drchandan1204@gmail.com9937063390

Outcome results

None listed

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