The safety and disposition of metformin in people with liver disease and diabetes already treated with metformi

Not Applicable

Completed

• Conditions: Diabetes; 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: ACTRN12619001348145
• 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: 2015-07-07
• Study Start: 2019-10-01
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Patients with chronic liver disease who are being treated with metformin for their type 2 diabetes mellitus.

Exclusion Criteria

No exclusion criteria.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of this study is the monitoring of a composite safety outcome including the concentrations of metformin and blood biochemistry to ensure they are below the safety thresholds of 5 mg/L and 5 mmol/L, respectively.[Venous blood samples will be obtained on the day of consultation at anytime post drug administration on up to 6 occasions. These blood samples will be used to determine: metformin concentrations, lactate concentrations, creatinine concentrations, fasting glucose and insulin concentration, and blood biochemistry.]

Secondary Outcome Measures

Name	Time	Method
The secondary outcome is to determine the pharmacokinetics of metformin by monitoring plasma metformin concentrations and using these to estimate an individual's pharmacokinetic parameters (CLMet/F apparent clearance of metformin; Vc/F, apparent volume of distribution of metformin in the central compartment; CLMet/F:CLCr ratio of the apparent clearance of metformin to creatinine clearance) using a population pharmacokinetic analysis approach.[The pharmacokinetics of metformin at steady-state (5 half-lives) will be determined from a single plasma metformin concentration obtained on the day of consultation at any time post drug administration. The pharmacokinetics of metformin in study participants will be compared to steady-state pharmacokinetic of metformin in healthy subjects and patients with type 2 diabetes and no known history of chronic liver disease reported in the literature.]