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Potential benefits of early addition of rosiglitazone in combination with glimepiride in the treatment of type 2 diabetes
Author(s) -
Rosenstock J.,
Chou H. S.,
Matthaei S.,
Seidel D. K.,
Hamann A.
Publication year - 2008
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.1463-1326.2007.00815.x
Subject(s) - glimepiride , rosiglitazone , type 2 diabetes , medicine , diabetes mellitus , endocrinology
Aim: To assess the efficacy and tolerability of early combination therapy with rosiglitazone (RSG) and glimepiride (GLIM) vs. GLIM monotherapy in patients with type 2 diabetes mellitus (T2DM). Methods: Strategies for the addition of RSG in combination with GLIM were evaluated with data from two randomized, double‐blind, placebo (PBO)‐controlled studies. Study A – addition of RSG (4 or 8 mg) or PBO to continued GLIM 3 mg once daily; study B – addition of low‐dose RSG (4 mg) prior to uptitration of GLIM (from 2 to 4 mg) vs. continued uptitration of GLIM (from 2 to 8 mg). Results: Study A reported significant reductions in fasting plasma glucose (FPG) from baseline to week 26 with the addition of both 4 and 8 mg RSG to GLIM 3 mg [−21 mg/dl (−1.2 mmol/l), p = 0.0019 and −43 mg/dl (−2.4 mmol/l), p < 0.0001, respectively] and in haemoglobin A 1c (HbA 1c ) (−0.63%, p = 0.00015 and −1.17%, p < 0.0001, respectively) from a baseline of 8.2 and 8.1%, respectively. At the end of the study, target HbA 1c <7.0% was achieved in 43 and 68% of patients in the RSG 4 mg + GLIM and RSG 8 mg + GLIM groups, respectively, compared with 32% in the PBO + GLIM (GLIM alone) group. In study B, addition of RSG to GLIM reduced mean FPG and HbA 1c levels at week 24 from baseline [−28 mg/dl (−1.5 mmol/l), p < 0.0001, and −0.68%, p < 0.0001, respectively]. There were no significant changes with GLIM monotherapy in either study. Favourable effects of RSG + GLIM on insulin sensitivity, β‐cell function and cardiovascular disease biomarkers were also observed. All treatments were similarly well tolerated. Conclusions: Early addition of RSG to GLIM is an effective and well‐tolerated treatment option to improve glycaemic control in sulphonylurea‐treated patients with T2DM.