Pharmacokinetics Clinical Trial
Official title:
Intraindividual Variation of Serum Metformin in a Cohort of Patients With Type 2 DM and Moderately Reduced Renal Function
Metformin is widely used for treatment of type 2 diabetes mellitus. Side-effects are few and
mainly from the gastrointestinal tract. Since metformin is cleared from the blood exclusively
via the kidneys reduced renal function is a relative contraindication. We have earlier
demonstrated that metformin safely can be used to a lower GFR level of 30 ml/min/1.73. Below
that level the risk of lactacidosis, a severe complication, increases.
In the present study we plan to analyse serum levels of metformin repeatedly in patients with
moderate renal failure (CKD = GFR of 30-60 ml/min/1.73). Blood samples will be taken as
trough values in the morning, week 0, 2, 4, and 8 and at four weeks a blood sample will be
taken two hours after intake of the morning dose of metformin. Renal function will be
estimated with creatinine and cystatin C at each occasion. The intraindividual variation of
metformin will be calculated.
The study rests on a new method for measuring metformin. The technique uses Liquid
Chromatography Tandem Mass Spectometry (LCMSMS). Proteins are removed from serum by adding
acetonitrile to the sample. After centrifugation a diluted portion of the supernatant is
injected into the LCMSMS-system. The total runtime for a sample is 6 minutes.
The study will show if variation in serum levels of metformin measured in the same patient is
high or low and thus give us better understanding whether a change i serum level is due to
biological variation or to increased retention caused by progressive renal failure.
n/a
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