Premium
Twice‐daily dosing of a repaglinide/metformin fixed‐dose combination tablet provides glycaemic control comparable to rosiglitazone/metformin tablet
Author(s) -
Raskin P.,
Lewin A.,
Reinhardt R.,
Lyness W.
Publication year - 2009
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/j.1463-1326.2009.01062.x
Subject(s) - metformin , repaglinide , medicine , rosiglitazone , fixed dose combination , regimen , type 2 diabetes , pharmacology , adverse effect , diabetes mellitus , endocrinology , insulin
Aim: To assess the use of a new repaglinide/metformin fixed‐dose combination (FDC) tablet for the treatment of type 2 diabetes. Methods: In this 26‐week, multicentre, open‐label, parallel‐group trial, subjects poorly controlled with mono‐ or dual‐oral antidiabetic therapy were randomized 1 : 1 : 1 to receive a repaglinide/metformin FDC tablet either two times daily (BID) or three times daily (TID) or a rosiglitazone/metformin FDC tablet BID. The primary objective comprised two hypotheses tested in a hierarchical order: (i) that treatment with the repaglinide/metformin FDC BID is non‐inferior to that of a rosiglitazone/metformin FDC tablet BID as measured by changes in haemoglobin A1c (HbA1c) (results presented here) and (ii) if true, that treatment with the repaglinide/metformin FDC BID was non‐inferior to that of the repaglinide/metformin FDC TID as measured by changes in HbA1c (results presented in a companion paper). Additional efficacy and safety end‐points were also assessed. Results: Of the 561 subjects randomized, 383 completed the study. Reductions in HbA1c values became apparent at earlier times for repaglinide/metformin FDC BID treatment than rosiglitazone/metformin FDC BID, and final changes in HbA1c were not significantly different between treatment arms (p = 0.8186); thus, the predefined statistical criterion for non‐inferiority was met. Overall adverse event profiles were comparable between treatment groups, and no major hypoglycaemic episodes were reported during the study. Conclusions: The repaglinide/metformin FDC BID regimen showed efficacy that was non‐inferior to that of the rosiglitazone/metformin FDC BID regimen currently in clinical use and a more rapid reduction of HbA1c values. Thus, repaglinide/metformin FDC BID is a clinically feasible alternative to rosiglitazone/metformin FDC BID.