The objective of the proposed study is to develop techniques for optimizing the dosage of metformin through measurement of the concentrations of the drug in plasma or red blood cells and the concentration of haemoglobin A1c in patients with diabetes…
ID
Source
Brief title
Condition
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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<60 ml/min/1.73m2.
Secondary outcome
• 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 < 60 ml/min/1.73m2
• Correlate red blood cell concentrations of metformin with renal function
(eGFR) in patients with type 2 diabetes and eGFR < 60 ml/min/1.73m2
• within-person day-to-day variability in plasma metformin concentration and
pharmacokinetic parameters
• Correlate pharmacogenetic polymorphisms with metformin pharmacokinetics and
pharmacodynamics in patients with type 2 diabetes and eGFR <60 ml/min/1.73m2
Background summary
Metformin is largely excreted unchanged in the urine and, consequently, its
dosage should be reduced in renal impairment or metformin should be
discontinued in order to avoid metformin toxicity with possible
life-threatening lactic acidosis. In clinical practice, metformin is prescribed
in many patients with diabetic nephropathy. Current clinical practice
guidelines recommend discontinuation of metformin when kidney function falls
below 60 ml/min/1.73m2. The basis for this guideline is poorly developed and
well conducted studies on the balance of benefits and risks in this population
are lacking.
Study objective
The objective of the proposed study is to develop techniques for optimizing the
dosage of metformin through measurement of the concentrations of the drug in
plasma or red blood cells and the concentration of haemoglobin A1c in patients
with diabetes and nephropathy and to correlate plasma metformin concentrations
and pharmacokinetic parameters with Hba1c and lactic acid levels. The ultimate
objective is to develop a dosage table which provides a reasonable initial
guide to prescribe metformin.
Study design
Observational study
Study burden and risks
Results of this study can contribute to practical decision rules and dosing
schedules for metformin in patients with diabetic nephropathy. The first blood
sample will be collected at the regular visit of the patient when blood is
already drawn for clinical laboratory parameters. The extra blood sample and
24-hour urine that is needed for this pharmacokinetic study outweigh the
potential benefits of improving dosing schedules for metformin.
Antonius Deusinglaan 1
Groningen 9713 AV
NL
Antonius Deusinglaan 1
Groningen 9713 AV
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL43847.042.13 |