Effect of Oral Anti-diabetic Medication on Liver Fat in Subjects With Type II Diabetes and Non-alcoholic Fatty Liver

PHASE4UnknownINTERVENTIONAL
Enrollment

123

Participants

Timeline

Start Date

September 15, 2021

Primary Completion Date

May 15, 2023

Study Completion Date

November 15, 2023

Conditions
Diabetes Mellitus, Type 2NASH - Nonalcoholic SteatohepatitisNAFLD
Interventions
DRUG

Pioglitazone

Pioglitazone with (or without) metformin and/or DPP4 inhibitor (no SGLT2 inhibitor). The maximum dose for metformin would be 2.5 g/day, while for pioglitazone would be 45mg/day. The maximum dose for DPP4 inhibitor would be 100mg/day.

DRUG

Empagliflozin

Empagliflozin with (or without) metformin and/or DPP4 inhibitor (no pioglitazone). The maximum dose for metformin would be 2.5g/day, while for empagliflozin would be 25mg/day depending on follow up blood sugar levels and tolerability. The maximum dose 100mg daily.

DRUG

Pioglitazone + Empagliflozin

Pioglitazone with (or without) metformin and/or DPP4 inhibitor, plus empagliflozin. The maximum dose for metformin would be 2.5g/day; for pioglitazone would be 45mg/day and 25mg/day for empagliflozin, and 100mg daily for DPP4 inhibitors (depending on follow up blood sugar levels and tolerability).

Trial Locations (1)

74800

RECRUITING

Aga Khan University Hospital, Karachi

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Getz Pharma

INDUSTRY

NCT04976283 - Effect of Oral Anti-diabetic Medication on Liver Fat in Subjects With Type II Diabetes and Non-alcoholic Fatty Liver | Biotech Hunter | Biotech Hunter