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

Not Applicable

Completed

• Conditions: Type 2 diabetes; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12611000908932
• Lead Sponsor: Prof Richard Day

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Patients with type 2 diabetes and taking metformin.

Exclusion Criteria

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To investigate the pharmacokinetics of metformin in patients with type 2 diabetes by developing a population pharmacokinetic model.[Metformin concentrations at different occasions within a patient for intra-patient variability and metformin concentrations between patients to examine inter-patient variability. The number of metformin concentrations is not fixed, therefore can range from 1 to 6.]

Secondary Outcome Measures

Name	Time	Method
To investigate factors influencing the pharmacokinetics of metformin between patients. This includes the influence of kidney function (creatinine clearance), body size descriptors (weight), age and genetic polymorphisms of transporters involved in the uptake of metformin.[At the first instance for each patient.]