Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Pharmacokinetics of Metformin Intolerance
Pharmacokinetic study of metformin intolerance
This pharmacokinetic study recruited white European individuals with type 2 diabetes, who had
previously been exposed to metformin and met the criteria for tolerance or intolerance.
Intolerance was defined as previous exposure to metformin (maximum of 1000mg once daily for
up to 8 weeks) but discontinued treatment with patient reported or documentation of
gastrointestinal upset, leading to discontinuation (Criterion 1). Alternatively, intolerance
was defined as inability to increase metformin dose above 500mg without experiencing
gastrointestinal side-effects, despite having an HbA1c >53mmol/mol (Criterion 2). Tolerant
individuals were defined as those taking 2000mg metformin daily in divided doses, with no
side effects. Ten tolerant and ten intolerant individuals were recruited.
Participants gave written consent. They attended the research centre fasted from midnight. A
baseline blood test was taken before a single dose of oral metformin was administered at
0900, with further bloods taken at 11 time points over the following 24 hours. A 24 hour
urine collection was completed.
Blood samples were analysed for plasma metformin, and serum lactate concentrations.
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