Pharmacokinetics and Pharmacodynamics of metformin in patients with type 2 diabetes and renal impairment

Pharmacokinetics and Pharmacodynamics of metformin in patients with type 2 diabetes and renal impairment - Metformin in diabetic nephropathy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON38577

Enrollment

110

Registered

2013-11-18

Start date

2013-11-19

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Diabetic Nephropathy

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: •Age >= 18 years •Patients prescribed metformin for at least 2 days •eGFR > 15 ml/min/1.73m2 •Willing to provide informed consent

Exclusion criteria

Exclusion criteria: •Need for chronic hemodialysis •Presence of severe debilitating illness at the discretion of the treating physician •Donation of blood to the blood bank in prior 3 months •Veins not suitable for venepuncture

Design outcomes

Primary

Measure	Time frame
Main study parameters/endpoints: The main study parameter is the correlation between the plasma concentration and pharmacokinetic parameters of metformin with Hba1c% in patients with type 2 diabetes and eGFR	—

Secondary

Measure	Time frame
• Correlation of pharmacokinetic parameters and plasma concentration of metformin with lactic acid • Correlate plasma concentrations of metformin with renal function (eGFR) in patients with type 2 diabetes and eGFR	—

Countries

Netherlands

Outcome results