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

The pharmacokinetics and safety of metformin in patients with liver disease and diabetes already treated with metformin

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12619001348145

Enrollment

Registered

2019-10-01

Start date

2014-07-04

Completion date

2015-06-18

Last updated

2019-10-07

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 (CLD) but there is little published data to support this warning. Despite this, metformin is used in patients with CLD. This study will investigate the safety and pharmacokinetics of metformin in patients with CLD who are already prescribed metformin to treat their type II diabetes mellitus (T2DM) . 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 is an observational, cross sectional study conducted in patients with liver disease who are already being treated with metformin for their T2DM. The doses of metformin will not be altered for these patients. The duration of observation in each patient is a one-off 2 hour consultation.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

No exclusion criteria.

Outcome results