Observational Study of the Efficacy of Immediate-Release Metformin in People with Prediabetes in Russia

Aim: To study the effects of metformin in prediabetes.Methods: This was an observational, non-interventional, uncontrolled study of the effects of the immediate-release formulation of metformin in 551 people with pre-diabetes, according to diagnostic criteria from the American Diabetes Association (ADA).Results: The study population was predominantly female (66%), and on average was middle-aged (mean age 54 [SD 12] years) and obese (mean body mass index 32 kg/m2 [SD 6]) at baseline.Treatment with metformin for 12 weeks was associated with a mean reduction in fasting plasma glucose (FPG) of -0.8 mmol/L (95%CI -0.8 to -0.9) from a baseline value of 6.3 mmol/L (SD 0.5).FPG was normalised, according to ADA criteria (<5.6 mmol/L) in 86% of the population, at 12 weeks (the primary endpoint of the study).Reductions from baseline were also seen for HbA1c (by -0.4% [95% CI -0.3 to -0.5]) and post-load glucose following an oral glucose tolerance test (by -2.0 mmol/L [95%CI -1.5 to -2.4]) at 12 weeks.These parameters were normalised according to ADA criteria in a majority of patients where data were available, although measurements were available from only 189 and 51 patients, respectively.A logistic regression analysis suggested significant influence of age and starting dose of metformin on the likelihood of normalisation of FPG.Adherence to metformin was high (>75% in 93% of the population).Metformin was well tolerated, with common finding of mild-to-moderate gastrointestinal side-effects, as expected.Conclusion: These real-world data add further evidence in support for a role for metformin in the management of people with prediabetes.