A study of factors affecting the concentrations of metformin in type 2 diabetic patients

The clinical pharmacokinetics of metformin in patients with type 2 diabetes

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12611000908932

Enrollment

120

Registered

2011-08-24

Start date

2008-05-06

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

This study investigates the use of metformin in patients with type 2 diabetes with an aim to develop a population pharmacokinetic model to describe the pharmacokinetics. It involves obtaining a medical history of the patient and asking patients about their metformin formulation, dose, dosing times and their compliance to the medication.

Interventions

This observational study involves recruiting patients who are taking metformin for their type 2 diabetes. Patients are required to provide a minimum of 1 blood sample and a maximum of 6 blood samples on different occasions. There are no fixed timing period. Blood samples are used to determine metformin concentrations, glycosylated haemoglobin (HbA1c), creatinine and lactic acid concentration.

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Healthy volunteers

Inclusion criteria

Patients with type 2 diabetes and taking metformin.

Exclusion criteria

Patients unable to provide informed consent to participate in the study.

Outcome results