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Effect of ranolazine on glycaemic control in patients with type 2 diabetes treated with either glimepiride or metformin
Author(s) -
Pettus J.,
McNabb B.,
Eckel R. H.,
Skyler J. S.,
Dhalla A.,
Guan S.,
Jochelson P.,
Belardinelli L.,
Henry R. H.
Publication year - 2016
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/dom.12629
Subject(s) - glimepiride , metformin , ranolazine , type 2 diabetes , medicine , diabetes mellitus , endocrinology
Aim To report the results of two phase III trials assessing the efficacy of ranolazine for glycaemic control in patients with type 2 diabetes on metformin or glimepiride background therapy. Methods In two double‐blind trials we randomized 431 and 442 patients with type 2 diabetes to ranolazine 1000 mg twice daily versus placebo added to either glimepiride (glimepiride add‐on study) or metformin background therapy (metformin add‐on study). Patients receiving ranolazine added to metformin had their metformin dose halved (with the addition of a metformin‐matched placebo) relative to the placebo group to correct for a metformin‐ranolazine pharmacokinetic interaction. The primary endpoint of the trials was the change from baseline in glycated haemoglobin ( HbA1c ) at week 24. Results When added to glimepiride, ranolazine caused a 0.51% least squares mean [95% confidence interval ( CI ) 0.71, 0.32] decrease from baseline in HbA1c at 24 weeks relative to placebo and roughly doubled the proportion of patients achieving an HbA1c of <7% (27.1 vs 14.1%; p = 0.001). When added to metformin background therapy, there was no significant difference in the 24‐week HbA1c change from baseline [placebo‐corrected LS mean difference −0.11% (95% CI −0.31, 0.1)]. Conclusions Compared with placebo, addition of ranolazine in patients with type 2 diabetes treated with glimepiride, but not metformin, significantly reduced HbA1c over 24 weeks. The decreased dose of metformin used in the metformin add‐on study complicates the interpretation of this trial. Whether an effective regimen of ranolazine added to metformin for glycaemic control can be identified remains unclear.