Single- and multiple-dose pharmacokinetics of repaglinide in patients withtype 2 diabetes and renal impairment

Objective: The primary objective of this single-centre, open-label, paralle l-group study was to evaluate the pharmacokinetics and safety profile of th e prandial glucose regulator repaglinide, following single and multiple dos ing, in patients with type 2 diabetes with and without varying degrees of r enal impairment. Methods: The study comprised three screening visits, follo wed by a 7-day inpatient period. Thirty-four patients, with normal renal fu nction (n = 12), mild-to-moderate renal dysfunction (12 = 12) or severe ren al dysfunction (n = 10), received a single 2-mg dose of repaglinide on day 1, followed by preprandial 2-mg doses with main meals (breakfast, lunch and dinner) on each of days 2-4. A final 2-mg dose of repaglinide was administ ered on day 5. Results: Patients with mild-to-moderate renal impairment showed no signific ant differences in the pharmacokinetics of repaglinide, compared with patie nts with normal renal function. In the group of patients with severe renal dysfunction, the main pharmacokinetic finding was a longer half-life after multiple dosing. Rates of minor hypoglycaemia were similar in patients with severe, mild-to-moderate and no renal dysfunction. No major hypoglycaemic episodes occurred. Conclusion: Patients with type 2 diabetes and mild or moderate impairment o f renal function may be treated with repaglinide without special precaution s. If repaglinide is used in patients with severely impaired renal function , dose adjustment may be necessary if indicated by blood glucose measuremen ts.