FindTrial
Sign In

Dapagliflozin is a licensed medicine used for reducing blood sugar in people with diabetes and this study will test whether it can also reduce the stiffness in the liver which commonly occurs in diabetes.

Efficacy and Safety of Dapagliflozin for reduction of steatohepatitis in patients of Type 2 diabetes with Nonalcoholic Steatohepatitis: A prospective, randomized, double-blinded, placebo-controlled study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/05/019286
Enrollment
160
Registered
2019-05-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

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

Interventions

Intervention1: Capsule Dapagliflozin: 5 mg once daily, orally, before breakfast, for 200 days Control Intervention1: Capsule Placebo: 5 mg orally, once daily, before breakfast, for 200 days

Sponsors

Dr Shashi Panicker
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects who are willing and given their informed consent prior to any study-specific prodedures. 2.Female or male aged 30 years or more 3. Recently diagnosed or known cases of type 2 diabetes 4.HbA1c above 7% 5.Presence of NASH 6.Fulfilment of criteria for non-alcoholic fatty liver disease 7.eGFR >45/ml/1.73m squared

Exclusion criteria

Exclusion criteria: 1.Diagnosis of Type 1 Diabetes 2.History of Bladder cancer 3.History of radiation therapy to the lower abdomen or pelvis at any time 4.Chronic cystitis and/ or recurrent urinary tract infections 5.Pregnant or breastfeeding women 6.Subjects with cirrhosis of the liver or obstructive biliary disease will be excluded. 7.Chronic Hepatitis B and hepatitis C 8.Subjects with alpha-1 antitrypsin deficiency and Wilsonâ??s disease will be excluded. 9.Patients on Tamoxifen, methotrexate, amiodarone, thiazolidinediones, incretin mimetics like liraglutide and DPP4 inhibitors, or SGLT2 inhibitors like dapagliflozin, canagliflozin, or empagliflozin, will be excluded from the study.

Design outcomes

Primary

MeasureTime frame
To determine whether dapagliflozin significantly reduces the degree of steatohepatitis in patients of type 2 diabetes with NASHTimepoint: 200 days—

Secondary

MeasureTime frame
Effects of dapagliflozin on: Obesity indices: Body weight, BMI, Waist circumference, Waist-Height Ratio, Visceral fat, Body fat Lipid profile Micro- or macroalbuminuria HbA1c Liver enzymes Serum Albumin Insulin resistance Urinary Albumin-creatinine ratio Pulse Wave Velocity for Arterial stiffness Liver functions Hepatic scores: NAFLD fibrosis score, FIB4 Score Platelet count, PCT, MPV Quality of Life Measurements Timepoint: 200 days;Resolution of NASH if liver stiffness measurement is less than 6 kPaTimepoint: 200 days—

Countries

India

Contacts

Public ContactDr Shashi Panicker

Mahatma Gandhi University of Medical Sciences and Technology,

gnsaxena@gmail.com9414043426

Outcome results

None listed

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