The safety and disposition of metformin in people with liver disease

The pharmacokinetics and safety of metformin in patients with liver disease

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619001292167

Enrollment

Registered

2019-09-19

Start date

2014-07-03

Completion date

2016-03-04

Last updated

2019-09-30

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

Conditions

None listed

Brief summary

Metformin is the first drug chosen to treat type 2 diabetes mellitus. However, the regulatory label warns against it use in people who also have chronic liver disease but there is little published data to support this warning. This study will investigate the safety and pharmacokinetics of metformin in patients with chronic liver disease (CLD) with or without type II diabetes mellitus (T2DM) who will be prescribed metformin (500 mg, immediate release, twice daily) for up to six weeks. We hypothesis that metformin at doses adjusted based on renal function can be safely administered to patients with CLD. Further, the pharmacokinetics of metformin in patients with CLD will be similar to those reported in patient with T2DM and no CLD.

Interventions

Metformin hydrochloride (oral tablet immediate release formulation). This prospective interventional study will be conducted in patients with varying degrees of liver disease who are not currently treated with metformin. Eligible patients will be prescribed a low oral dose of metformin (500 mg, immediate-release formulation, twice daily) for 6 weeks. Participants will be required to complete a diary describing the day and time of study medication ingestion.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

Outcome results