The Effect of Empagliflozin on NAFLD in Asian Patients With Type 2 Diabetes
- Sponsor
- University of Malaya
- Study ID
- NCT02964715
- Phase
- PHASE4
- Status
- Unknown
Conditions
- NAFLD
- Type2 Diabetes
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Empagliflozin — DRUG25 mg daily for 6 months
Study Details
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.
Key Dates
- Start date
- Nov 30, 2016
- Status verified
- May 2017
- Primary completion
- Nov 30, 2018
- Completion
- Nov 30, 2018
Study Design
- Enrollment
- 25 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Interventional armPatients with NAFLD and Type 2 Diabetes prescribed 25mg empagliflozin(JARDIANCE) daily for 6 months
Primary Outcome Measure
Change in histological Grade as evaluated with Non-alcoholic Steatohepatitis Clinical Research Network Scoring System [ Time Frame: baseline, 6 months ]
Central Contacts
- Shireene R Vethakkan, MD0162093355
- Wah K Chan, MRCP0163655232
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