Effect of ranolazine on glycaemic control in patients with type 2 diabetes treated with either glimepiride or metformin

J. Pettus, B. Mcnabb, R. H. Eckel, J. S. Skyler, A. Dhalla, S. Guan, P. Jochelson, L. Belardinelli, R. H. Henry

Research output: Contribution to journalArticlepeer-review

11 Scopus citations

Abstract

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 1000mg 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 24weeks 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 24weeks. 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.

Original languageEnglish (US)
Pages (from-to)463-474
Number of pages12
JournalDiabetes, Obesity and Metabolism
Volume18
Issue number5
DOIs
StatePublished - May 1 2016
Externally publishedYes

Keywords

  • Antidiabetic drug
  • Clinical trial
  • Glycaemic control
  • Randomized trial
  • Type 2 diabetes

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

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