The Effect of Empagliflozin on NAFLD in Asian Patients With Type 2 Diabetes

• Status: Unknown status
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Non-Alcoholic Fatty Liver Disease( NAFLD) is common in patients with type 2 diabetes. Empagliflozin, an FDA-approved oral medication used to treat type 2 diabetes, has been shown to reduce production and deposition of fat in the liver in animal experiments. There is little published evidence that this is so in Asian patients with type 2 diabetes. The investigators designed this pilot study to determine if use of empagliflozin for 6 months in patients with type 2 diabetes can improve scan, blood marker and biopsy features of NAFLD.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Malaya
• Treatments: Empagliflozin

Criteria

Inclusion Criteria:

• biopsy proven NASH

• Type 2 DM

• HbA1c :>6.5%

• BMI < 45kg/m2

• Any anti-diabetic agent except SGLT2 inhibitors, TZDs(thiazolidinediones), DPP4(Dipeptidyl peptidase4) inhibitors and GLP1 RAs(Glucagon-like Peptide 1-Receptor Agonists)

Exclusion Criteria:

• eGFR <45 ml/min

• structural and functional urogenital abnormalities, that predispose for urogenital infections

• Investigational product use in the last 6 months

• SGLT2 inhibitor, TZD, DPP4 inhibitor and GLP1 RA use within the past 6 months

• DKA(Diabetic Ketoacidosis) or HHS(Hyperosmoloar Hyperglycaemic Syndrome) within the last 6 months

• Pregnancy

• Presence of major contraindications to magnetic resonance imaging (cardiac pacemakers, claustrophobia, foreign bodies and implanted medical devices with ferromagnetic properties).

• Liver cirrhosis

• Type 1 diabetes

• Severe uncorrected insulin insufficiency

• Significant alcohol intake

• HIV infection

• Use of Traditional Chinese Medication or alternative therapies

• Coexisting causes of chronic liver disease - chronic viral hepatitis(B & C), autoimmune liver disease, hemochromatosis, Wilson's etc.

• Use of medications associated with steatosis eg. Methotrexate, anticonvulsants, antiretroviral therapy etc.

• h/o stroke

• Steroid therapy

• Endogenous Cushing's

• Familial hypertriglyceridemia