A pharmacokinetic dose-variation study of metformin and gemigliptin pharmacovigilance, and the clinical pharmacological significance of recent anti-diabetic pharmaceuticals

Introduction: Anti-diabetic biguanides, like metformin, cause activation of AMP dependent protein kinase, and overcomes insulin resistance. Anti-dipeptidyl peptidase-4hypoglycaemic drugs, like gemigliptin, cause augmented beta-cell function by ameliorating the anti-beta cell apoptotic serum incretins, such as, glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide.
Objectives: The objective of this study was to evaluate metformin and gemigliptin pharmacovigilance with pharmacokinetic dose-variation, and the clinical pharmacological significance of recent anti-diabetic pharmaceuticals.
Methods: In this study, new early grade type II diabetic, Group A = 50 patients, were prescribed oral 250 mg metformin once daily, for 43 days, and then 500 mg metformin once daily, for the next 43 days, and further; and Group B = 50 patients, were prescribed oral 25 mg gemigliptin once daily, for 43 days, and then 50 mg gemigliptin once daily, for the next 43 days, and further. The safety assessment was done by the monitoring of adverse drug reactions, like hypoglycaemia, weakness, gastrointestinal disturbances, abdominal pain and upper respiratory tract infections, in Group A, and nasopharyngitis, hypoglycaemia, gastrointestinal disturbances, headache, nausea, rashes, urticaria, oedema, and weakness, in Group B, with Adverse Event Case Report Forms, on days 0, 43, 86, and on further follow-ups, with statistical analysis of the study findings. The clinical pharmacological significance of metformin and gemigliptin was also analysed.
Results: In this study, there was absence of any significant occurrence of adverse drug reactions, on days 0, 43, 86, and on further follow-ups, with accelerating doses of metformin and gemigliptintherapy. The analysis demonstrated ample clinical pharmacological significance of metformin and gemigliptin.
Conclusions: Metformin and gemigliptin were safe and tolerable, with anti-diabetic pharmacotherapeutic drug-dose variations, with requisite clinical pharmacological significance.