The safety and disposition of metformin in people with liver disease

Phase 4

Completed

• Conditions: Metabolic and Endocrine - Diabetes; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Chronic liver disease

• Registration Number: ACTRN12619001292167
• Lead Sponsor: St Vincent's Hospital, Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-08-31
• Study Start: 2019-09-19
• Last Update Posted: 30 September 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Patients with chronic liver disease who are naïve to metformin treatment and do not have a diagnosis of type 2 diabetes mellitus.

Exclusion Criteria

Significant renal impairment (eGFR < 30 mL/min), or women lactating, pregnant or of childbearing potential and unwilling to avoid becoming pregnant during the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to investigate the safety of metformin in patients with all-cause chronic liver disease, with varying degrees of liver fibrosis and cirrhosis, with or without type 2 diabetes mellitus by monitoring the concentrations of metformin and blood biochemistry (composite primary outcome).[Venous blood samples will be obtained at Week 0 (screening visit), 1, 2, 3, 4, 5 and 6. These blood samples will be used to determine: metformin concentrations, lactate concentrations, creatinine concentrations, fasting glucose and insulin concentration, and blood biochemistry.]