Vnitr Lek 2016, 62(9):705-711
Clinical efficacy and safety of basal insulin analogue glargine in patients with type 2 diabetes mellitus
- III. interní klinika 1. LF UK a VFN v Praze
Basal insulin has a clearly defined position in the recommendations for the treatment of patients with type 2 diabetes mellitus. General most common indication for administration is the addition in situation of the failure of noninsulin antidiabetic therapy or early insulin treatment of diabetes, as one of the second choice after metformin. In the recent years there is significant expansion of the range of antidiabetic drugs, including basal insulin analogues. In connection with the introduction of concentrated long-acting basal insulin analogues into the clinical practice many questions regarding clinical efficacy and safety raises especially comparing with the "classical" basal insulin analogues. Although it is very likely that in the current clinical practice these differences in a number of indications are of minimal impact, it is possible that in some situations clinically relevant differences can be found among the basal insulin analogues.
Keywords: basal insulin analogues; concentrated insulin; diabetes mellitus; EDITION trial; glargine; hypoglycemia; insulin therapy
Received: August 9, 2016; Accepted: September 6, 2016; Published: September 1, 2016 Show citation
References
- Fonseca V, Gill J, Zhou R et al. An analysis of early insulin glargine added to metformin with or without sulphonylurea: impact on glycaemic control and hypoglycaemia. Diabetes Obes Metab 2011; 13(9): 814-822. Dostupné z DOI: <http://dx.doi.org/10.1111/j.1463-1326.2011.01412.x>.
Go to original source...
Go to PubMed...
- [Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC) Study Research Group]. Intensive Diabetes Treatment and Cardiovascular Outcomes in Type 1 Diabetes: The DCCT/EDIC Study 30-Year Follow-up. Diabetes Care 2016; 39(5): 686-693. Dostupné z DOI: <http://dx.doi.org/10.2337/dc15-1990>.
Go to original source...
Go to PubMed...
- Khunti K, Nikolajsen A, Thorsted BL et al. Clinical inertia with regard to intensifying therapy in people with type 2 diabetes treated with basal insulin. Diabetes Obes Metab 2016; 18(4): 401-409. Dostupné z DOI: <http://dx.doi.org/10.1111/dom.12626>.
Go to original source...
Go to PubMed...
- Pratley RE, Kuritzky L, Tenzer P. A patient-centered approach to managing patients with type 2 diabetes. Am J Med. 2014; 127(11): e15-e16. Dostupné z DOI: <http://dx.doi.org/10.1016/j.amjmed.2014.10.007>.
Go to original source...
Go to PubMed...
- Edelman S, Pettus J. Challenges associated with insulin therapy in type 2 diabetes mellitus. Am J Med 2014; 127(10 Suppl): S11-S16. Dostupné z DOI: <http://dx.doi.org/10.1016/j.amjmed.2014.07.003>.
Go to original source...
Go to PubMed...
- Cahn A, Miccoli R, Dardano A et al. New forms of insulin and insulin therapies for the treatment of type 2 diabetes. Lancet Diabetes Endocrinol 2015; 3(8): 638-652. Dostupné z DOI: <http://dx.doi.org/10.1016/S2213-8587(15)00097-2>.
Go to original source...
Go to PubMed...
- Owens DR, Rosenstock J. New forms of insulin analogs in development: the quest for a better basal insulin. In: Umpierrez GE, Alexandria, VA (eds) Therapy for Diabetes Mellitus and Related Disorders. 6th ed. American Diabetes Association 2014: 480-507. ISBN 978-1580405096.
- Barthel A, Schmoll D. Novel concepts in insulin regulation of hepatic gluconeogenesis. Am J Physiol Endocrinol Metab 2003; 285(4): E685-E692.
Go to original source...
Go to PubMed...
- Owens DR, Matfin G, Monnier L. Basal insulin analogues in the management of diabetes mellitus: What progress have we made? Diabetes Metab Res Rev 2014; 30(2): 104-119. Dostupné z DOI: <http://dx.doi.org/10.1002/dmrr.2469>.
Go to original source...
Go to PubMed...
- Zinman B. Newer insulin analogs: advances in basal insulin replacement. Diabetes Obes Metab 2013; 15(Suppl 1): S6-S10. Dostupné z DOI: <http://dx.doi.org/10.1111/dom.12068>.
Go to original source...
Go to PubMed...
- Zinman B, Fulcher G, Rao PV et al. Insulin degludec, an ultra-long-acting basal insulin, once a day or three times a week versus insulin glargine once a day in patients with type 2 diabetes: a 16-week, randomised, open-label, phase 2 trial. Lancet 2011; 377(9769): 924-931. Dostupné z DOI: <http://dx.doi.org/10.1016/S0140-6736(10)62305-7>.
Go to original source...
Go to PubMed...
- Gerstein HC, Bosch J, Dagenais GR et al. [ORIGIN Trial Investigators]. Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med 2012; 367(4): 319-328. Dostupné z DOI: <http://dx.doi.org/10.1056/NEJMoa1203858>.
Go to original source...
Go to PubMed...
- Laubner K, Molz K, Kerner W et al. Daily insulin doses and injection frequencies of neutral protamine hagedorn (NPH) insulin, insulin detemir and insulin glargine in type 1 and type 2 diabetes: a multicenter analysis of 51964 patients from the German/Austrian DPVswiss database. Diabetes Metab Res Rev 2014; 30(5): 395-404. Dostupné z DOI: <http://dx.doi.org/10.1002/dmrr.2500>.
Go to original source...
Go to PubMed...
- [ORIGIN Trial Investigators]. Cardiovascular and Other Outcomes Postintervention With Insulin Glargine and Omega-3 Fatty Acids (ORIGINALE). Diabetes Care 2016; 39(5): 709-716. Dostupné z DOI: <http://dx.doi.org/10.2337/dc15-1676>.
Go to original source...
Go to PubMed...
- Lonn EM, Bosch J, Diaz R et al. [GRACE and ORIGIN Investigators]. Effect of insulin glargine and n-3FA on carotid intima-media thickness in people with dysglycemia at high risk for cardiovascular events: the glucose reduction and atherosclerosis continuing evaluation study (ORIGIN-GRACE). Diabetes Care 2013; 36(9): 2466-2474. Dostupné z DOI: <http://dx.doi.org/10.2337/dc12-2129>.
Go to original source...
Go to PubMed...
- Becker RH, Dahmen R, Bergmann K et al. New insulin glargine 300 units z mL-1 provides a more even activity profile and prolonged glycemic control at steady state compared with insulin glargine 100 units/ml. Diabetes Care 2015; 38(4): 637-643. Dostupné z DOI: <http://dx.doi.org/10.2337/dc14-0006>.
Go to original source...
Go to PubMed...
- Becker RH, Nowotny I, Teichert L et al. Low within- and between-day variability in exposure to new insulin glargine 300 U/ml. Diabetes Obes Metab 2015; 17(3): 261-267. Dostupné z DOI: <http://dx.doi.org/10.1111/dom.12416>.
Go to original source...
Go to PubMed...
- Riddle MC, Bolli GB, Ziemen M et al. EDITION 1 Study Investigators. Newinsulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using basal and mealtime insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 1). Diabetes Care 2014; 37(10): 2755-2762. Dostupné z DOI: <http://dx.doi.org/10.2337/dc14-0991>.
Go to original source...
Go to PubMed...
- Yki-Jarvinen H, Bergenstal R, Ziemen M et al. [EDITION 2 Study Investigators]. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using oral agents and basal insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 2). Diabetes Care 2014; 37(12): 3235-3243. Dostupné z DOI: <http://dx.doi.org/10.2337/dc14-0990>.
Go to original source...
Go to PubMed...
- Bolli GB, Riddle MC, Bergenstal RM et al. [EDITION 3 study investigators]. New insulin glargine 300 U/ml compared with glargine 100 U/ml in insulin-naïve people with type 2 diabetes on oral glucose-lowering drugs: a randomized controlled trial (EDITION 3). Diabetes Obes Metab 2015; 17(4): 386-394. Dostupné z DOI: <http://dx.doi.org/10.1111/dom.12438>.
Go to original source...
Go to PubMed...
- Home PD, Bergenstal RM, Bolli GB et al. New Insulin Glargine 300 Units/mL Versus Glargine 100 Units/mL in People With Type 1 Diabetes: A Randomized, Phase 3a, Open-Label Clinical Trial (EDITION 4). Diabetes Care 2015; 38(12): 2217-2225. Dostupné z DOI: <http://dx.doi.org/10.2337/dc15-0249>.
Go to original source...
Go to PubMed...
- Ritzel R, Roussel R, Bolli GB et al. New insulin glargin 300 U/ml: glycaemic control and hypoglycaemia in an metaanalysis of phase 3a EDITION clinical trials in people with type 2 diabetes mellitus. Diabetologia 2014; 57(Suppl 1): S394.
- Riddle MC, Bolli GB, Home PD et al. Efficacy and Safety of Flexible Versus Fixed Dosing Intervals of Insulin Glargine 300 U/mL in People with Type 2 Diabetes. Diabetes Technol Ther 2016; 18(4): 252-257. Dostupné z DOI: <http://dx.doi.org/10.1089/dia.2015.0290>.
Go to original source...
Go to PubMed...
- Pettus J, Santos Cavaiola T, Tamborlane WV et al. The past, present, and future of basal insulins. Diabetes Metab Res Rev 2016; 32(6): 478-496. Dostupné z DOI: <http://dx.doi.org/10.1002/dmrr.2763>.
Go to original source...
Go to PubMed...