By Colin Kenny, Editor – Diabetes Distilled
The investigators carried out three complementary studies in 78 people with type 2 diabetes. The first study was a dose-finding analysis in CKD stages 1–5. The second was a 4-month metformin treatment study for validating the optimal metformin dose as a function of the CKD stage (3A, 3B and 4), with blood metformin, lactate and HbA1c concentrations monitored monthly. The third was an assessment of pharmacokinetic parameters after the administration of a single dose of metformin in steady-state CKD stages 3A, 3B and 4.
They established, in the dose-finding study, that the appropriate daily dosing schedules were 1.5 g (0.5 g in the morning and 1 g in the evening ) in CKD stage 3A, 1 mg (0.5 g and 0.5 g) in CKD stage 3B, and 0.5 g in CKD stage 4. In the second study, after 4 months on these regimens, participants displayed stable metformin concentrations that never exceeded the generally accepted safe upper limit of 5.0 mg/L and HbA1c levels did not change. In the third study, there were no significant differences in pharmacokinetic parameters among the CKD stage groups. The investigators concluded that, with adjustment for renal function, metformin treatment was safe and still pharmacologically efficacious in moderate-to-severe CKD.
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