Efficacy of Empagliflozin and Pioglitazone in Diabetic Patients With NAFLD

Sponsor
Jinnah Postgraduate Medical Centre
Study ID
NCT05942963
Phase
PHASE4
Status
Unknown

Conditions

  • Non-Alcoholic Fatty Liver Disease
  • Type2diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin 10 MG — DRUG
    10-25 mg/day
  • Pioglitazone 15mg — DRUG
    15-45 mg/day
  • Metformin — DRUG
    1000mg-2850mg/ day

Study Details

This clinical trial will yield results about the therapeutic effect of combining pioglitazone with SGLT2i in people suffering from NAFLD associated with T2DM. Study participants will be asked to fill out a few questions on proforma that will obtain demographic information as well as information relating to their health. In addition, some blood tests will be done following standard procedures.

Key Dates

Start date
Oct 31, 2023
Status verified
Jul 2023
Primary completion
Apr 30, 2024
Completion
Apr 30, 2024

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A
    SOC+ Empagliflozin + Pioglitazone
  • Experimental: Group B
    SOC +Empagliflozin
  • Experimental: Group C
    SOC+ Pioglitazone
  • Active Comparator: Group D
    SOC only

Primary Outcome Measure

A change in liver steatosis will be assessed through fibro CAP score. [ Time Frame: Will be assessed at enrollment. ]

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