Cardiovascular and other outcomes postintervention with insulin glargine and omega-3 fatty acids (ORIGINALE)

Journal article

ORIGIN Trial Investigators* and Chan, Yih. (2016). Cardiovascular and other outcomes postintervention with insulin glargine and omega-3 fatty acids (ORIGINALE). Diabetes Care. 39(5), pp. 709-716. https://doi.org/10.2337/dc15-1676
AuthorsORIGIN Trial Investigators* and Chan, Yih
Abstract

OBJECTIVE
The Outcome Reduction With Initial Glargine Intervention (ORIGIN) trial reported neutral effects of insulin glargine on cardiovascular outcomes and cancers and reduced incident diabetes in high–cardiovascular risk adults with dysglycemia after 6.2 years of active treatment. Omega-3 fatty acids had neutral effects on cardiovascular outcomes. The ORIGIN and Legacy Effects (ORIGINALE) study measured posttrial effects of these interventions during an additional 2.7 years.

RESEARCH DESIGN AND METHODS
Surviving ORIGIN participants attended up to two additional visits. The hazard of clinical outcomes during the entire follow-up period from randomization was calculated.

RESULTS
Of 12,537 participants randomized, posttrial data were analyzed for 4,718 originally allocated to insulin glargine (2,351) versus standard care (2,367), and 4,771 originally allocated to omega-3 fatty acid supplements (2,368) versus placebo (2,403). Posttrial, small differences in median HbA1c persisted (glargine 6.6% [49 mmol/mol], standard care 6.7% [50 mmol/mol], P = 0.025). From randomization to the end of posttrial follow-up, no differences were found between the glargine and standard care groups in myocardial infarction, stroke, or cardiovascular death (1,185 vs. 1,165 events; hazard ratio 1.01 [95% CI 0.94–1.10]; P = 0.72); myocardial infarction, stroke, cardiovascular death, revascularization, or hospitalization for heart failure (1,958 vs. 1,910 events; 1.03 [0.97–1.10]; P = 0.38); or any cancer (524 vs. 529 events; 0.99 [0.88–1.12]; P = 0.91) or between omega-3 and placebo groups in cardiovascular death (688 vs. 700; 0.98 [0.88–1.09]; P = 0.68) or other outcomes.

CONCLUSIONS
During >6 years of treatment followed by >2.5 years of observation, insulin glargine had neutral effects on health outcomes and salutary effects on metabolic control, whereas omega-3 fatty acid supplementation had no effect.

Year2016
JournalDiabetes Care
Journal citation39 (5), pp. 709-716
PublisherAmerican Diabetes Association
ISSN0149-5992
Digital Object Identifier (DOI)https://doi.org/10.2337/dc15-1676
Scopus EID2-s2.0-84964754284
Research or scholarlyResearch
Page range709-716
Publisher's version
License
All rights reserved
File Access Level
Controlled
Output statusPublished
Publication dates
Online01 May 2016
Publication process dates
Accepted09 Nov 2015
Deposited08 Feb 2022
Additional information

*Please see the article for the full list of authors.

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Postprandial response of adiponectin, interleukin-6, tumor necrosis factor-alpha, and C-reactive protein to a high-fat dietary load
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A copper(II)-selective chelator ameliorates diabetes-evoked renal fibrosis and albuminuria, and suppresses pathogenic TGF-β activation in the kidneys of rats used as a model of diabetes
Gong, D., Lu, J., Chen, X., Reddy, S., Crossman, D. J., Glyn-Jones, S., Choong, Y.-S., Kennedy, J., Barry, B., Zhang, S., Chan, Y.-K., Ruggiero, K., Phillips, A. R. J. and Cooper, G. J. S.. (2008). A copper(II)-selective chelator ameliorates diabetes-evoked renal fibrosis and albuminuria, and suppresses pathogenic TGF-β activation in the kidneys of rats used as a model of diabetes. Diabetologia. 51(9), pp. 1741-1751. https://doi.org/10.1007/s00125-008-1088-7
Triethylenetetramine and metabolites: levels in relation to copper and zinc excretion in urine of healthy volunteers and type 2 diabetic patients
Lu, Jun, Chan, Kai, Gamble, Gregory D., Poppitt, S D., Othman, Asma A. and Cooper, G. J. S.. (2007). Triethylenetetramine and metabolites: levels in relation to copper and zinc excretion in urine of healthy volunteers and type 2 diabetic patients. Drug Metabolism and Disposition. 35(2), pp. 221 - 227. https://doi.org/10.1124/dmd.106.012922
Determination of triethylenetetramine (TETA) and its metabolites in human plasma and urine by liquid chromatography-mass spectrometry (LC-MS)
Lu, Jun, Chan, Kai, Poppitt, S. D. and Cooper, G J. S.. (2007). Determination of triethylenetetramine (TETA) and its metabolites in human plasma and urine by liquid chromatography-mass spectrometry (LC-MS). Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences. 859(1), pp. 62 - 68. https://doi.org/10.1016/j.jchromb.2007.09.001
Effect of high-fat meals and fatty acid saturation on postprandial levels of the hormones ghrelin and leptin in healthy men
Poppitt, S. D., Leahy, F. E., Keogh, G. F., Wang, Y, Mulvey, T B., Stojkovic, M, Chan, Kai, Choong, Y S., McArdle, B H. and Cooper, G. J. S.. (2006). Effect of high-fat meals and fatty acid saturation on postprandial levels of the hormones ghrelin and leptin in healthy men. European Journal of Clinical Nutrition. 60(1), pp. 77 - 84. https://doi.org/10.1038/sj.ejcn.1602270
Molecular changes evoked by triethylenetetramine treatment in the extracellular matrix of the heart and aorta in diabetic rats
Gong, Deming, Lu, Jun, Chen, Xiuyin, Choong, Soon Y., Zhang, Shaoping, Chan, Kai, Glyn-Jones, Sarah, Gamble, Gregory D., Phillips, Anthony R. J. and Cooper, Garth J. S.. (2006). Molecular changes evoked by triethylenetetramine treatment in the extracellular matrix of the heart and aorta in diabetic rats. Molecular Pharmacology. 70(6), pp. 2045 - 2051. https://doi.org/10.1124/mol.106.028605
Demonstratuon of hyperglycemia-driven pathogenic abnormality of copper homeostasis in diabetes and its reversibility by selective chelation
Cooper, G. J. S., Chan, Kai, Dissanayake, Ajith M., Leahy, Fiona E., Keogh, Geraldine F., Frampton, Chris M., Gamble, Gregory D., Brunton, Dianne H., Baker, John R. and Poppitt, S D.. (2005). Demonstratuon of hyperglycemia-driven pathogenic abnormality of copper homeostasis in diabetes and its reversibility by selective chelation. Diabetes. 54(5), pp. 1468 - 1476.
Regeneration of the heart in diabetes by selective copper chelation
Cooper, G. J. S., Phillips, Anthony R. J., Choong, Soon Y., Leonard, Bridget L., Crossman, David J., Brunton, Dianne H., Saafi, Etuate L., Dissanayake, Ajith M., Cowan, Brett R., Young, Alistair A., Occleshaw, Christopher J., Chan, Kai, Leahy, Fiona E., Keogh, Geraldine F., Gamble, Gregory D., Allen, Grant R., Pope, Adele J., Boyd, Peter D. W., Poppitt, S D., ... Baker, John R.. (2004). Regeneration of the heart in diabetes by selective copper chelation. Diabetes. 53(9), pp. 2501 - 2508.