Pharmacokinetics and Pharmacodynamics of metformin in patients with type 2 diabetes and renal impairment
Completed
- Conditions
- Diabetic Nephropathy10012653
- Registration Number
- NL-OMON38577
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 110
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
•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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameters/endpoints: The main study parameter is the correlation<br /><br>between the plasma concentration and pharmacokinetic parameters of metformin<br /><br>with Hba1c% in patients with type 2 diabetes and eGFR<60 ml/min/1.73m2.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Correlation of pharmacokinetic parameters and plasma concentration of<br /><br>metformin with lactic acid<br /><br>• Correlate plasma concentrations of metformin with renal function (eGFR) in<br /><br>patients with type 2 diabetes and eGFR < 60 ml/min/1.73m2<br /><br>• Correlate red blood cell concentrations of metformin with renal function<br /><br>(eGFR) in patients with type 2 diabetes and eGFR < 60 ml/min/1.73m2<br /><br>• within-person day-to-day variability in plasma metformin concentration and<br /><br>pharmacokinetic parameters<br /><br>• Correlate pharmacogenetic polymorphisms with metformin pharmacokinetics and<br /><br>pharmacodynamics in patients with type 2 diabetes and eGFR <60 ml/min/1.73m2</p><br>