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Diabetes Care. 2015 Jul;38(7):1189-96. doi: 10.2337/dc14-2629. Epub 2015 Jun 6.

Effect of Ranolazine Monotherapy on Glycemic Control in Subjects With Type 2 Diabetes.

Author information

1
Divisions of Endocrinology, Metabolism and Diabetes and Cardiology, Department of Medicine, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, CO robert.eckel@ucdenver.edu.
2
Center for Metabolic Research, VA San Diego Healthcare System, San Diego, CA Division of Endocrinology and Metabolism, University of California, San Diego, La Jolla, CA.
3
Cardiovascular Clinical Research, Gilead Sciences, Foster City, CA.
4
Department of Biology, Cardiovascular Therapeutic Area, Gilead Sciences, Fremont, CA.
5
Cardiovascular Therapeutic Area, Biostatistics, Gilead Sciences, Foster City, CA.
6
Cardiovascular Clinical Research, Gilead Sciences, Foster City, CA Department of Biology, Cardiovascular Therapeutic Area, Gilead Sciences, Fremont, CA.
7
Divisions of Endocrinology, Diabetes, and Metabolism, Pediatrics, and Psychology, University of Miami Miller School of Medicine, Miami, FL.

Abstract

OBJECTIVE:

Ranolazine is an antianginal drug that mediates its effects by inhibition of cardiac late sodium current. Although ranolazine is not approved for the treatment of type 2 diabetes, in post hoc analyses of pivotal angina trials, ranolazine was associated with reductions in percent glycosylated hemoglobin (HbA1c) in subjects with type 2 diabetes. The study prospectively assessed the safety and efficacy of ranolazine in subjects with type 2 diabetes with inadequate glycemic control managed by lifestyle alone.

RESEARCH DESIGN AND METHODS:

The study was conducted worldwide in 465 subjects, with baseline HbA1c of 7-10% (53-86 mmol/mol) and fasting serum glucose of 130-240 mg/dL, randomized to placebo versus ranolazine.

RESULTS:

Compared with placebo, there was a greater decline in HbA1c at week 24 from baseline (primary end point) in subjects taking ranolazine (mean difference -0.56% [-6.1 mmol/mol]; P < 0.0001). Moreover, the proportion of subjects achieving an HbA1c <7.0% was greater with ranolazine (25.6% vs. 41.2%; P = 0.0004). Ranolazine was associated with reductions in fasting (mean difference -8 mg/dL; P = 0.0266) and 2-h postprandial glucose (mean difference -19 mg/dL; P = 0.0008 vs. placebo). Subjects taking ranolazine trended toward a greater decrease from baseline in fasting insulin (P = 0.0507), a greater decrease in fasting glucagon (P = 0.0003), and a lower postprandial 3-h glucagon area under the curve (P = 0.0031 vs. placebo). Ranolazine was safe and well tolerated.

CONCLUSIONS:

Compared with placebo, use of ranolazine monotherapy over 24 weeks, in subjects with type 2 diabetes and inadequate glycemic control on diet and exercise alone, significantly reduced HbA1c and other measures of glycemic control.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01472185.

PMID:
26049552
PMCID:
PMC4477340
DOI:
10.2337/dc14-2629
[Indexed for MEDLINE]
Free PMC Article

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