IGlarLixi represents a better choice compared to biphasic insulin when intensifying basal insulin therapy


Authors: Emil Martinka
Authors‘ workplace: Národný endokrinologický a diabetologický ústav, n. o., Ľubochňa
Published in: Forum Diab 2021; 10(3): 201-206
Category:

Overview

Intensification of basal insulin treatment by switching to biphasic insulin is an effective treatment, but at the expense of weight gain and an increased risk of hypoglycemia. In addition, glycemic control targets with biphasic insulin are only achieved in a limited proportion of patients. Currently, the preferred method of intensification is to switch to a fixed combination of basal insulin and a GLP-1 receptor agonist such as the combination of insulin glargin and the GLP-1 receptor agonist lixisenatide (IGlarLixi). Previous comparisons of biphasic insulin versus IGlarLixi fixed combination treatment have relied only on indirect comparisons that have shown that IGlarLixi associates with better efficacy and safety profile compared to the biphasic insulin regimen, with higher HbA1c reduction, lower risk of hypoglycemia and weight gain, and that IGlarLixi offers a simpler once-daily treatment regimen without the need for intensive self-monitoring, thus contributing to improved quality of life and adherence to treatment. Recently, the results of the first “head-to-head” RCT study SOLIMIX comparing the titratable fixed combination IGlarLixi with biphasic insulin BIAsp 30 were also presented. The results of SOLIMIX showed better efficacy and safety of IGlarLixi compared to biphasic insulin. IGlarLixi demonstrated non-inferiority over BIAsp 30 in HbA1c change and subsequent hierarchical testing demonstrated superiority of IGlarLixi in reducing HbA1c over BIAsp 30. IGlarLixi also demonstrated superiority over BIAsp 30 in weight change. During treatment, a lower incidence of hypoglycemia as well as a lower number of hypoglycemia was observed in the IGlarLixi group compared to the BIAsp 30 group. At the same time, achieving the goal for HbA1c without weight gain and without hypoglycemia was significantly more common with IGlarLixi than with BIAsp 30. The results of the studies so clearly demonstrate medical benefits and justify a preference for a fixed combination basal insulin treatment.

Keywords:

basal insulin – intensification – IGlarLixi – biphasic insulin


Sources

1. Davies MJ, D‘Alessio DA, Judith Fradkin J et al. Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2018; 41(12): 2669–2701. Dostupné z DOI: <http://dx.doi.org/10.2337/dci18–0033>.

2. Martinka E, Tkáč I, Mokáň M (eds). Interdisciplinárne štandardy diagnostiky a liečby diabetes mellitus, jeho komplikácií a najvýznamnejších sprievodných ochorení. Forum Diab 2018; 7(2 Suppl 1): 69–73.3.

3. Martinka E, Rončáková M, Davani A. Fixná kombinácia inzulínu glargín 100 U/ml a lixisenatidu (IGlarLixi) – výhodný spôsob intenzifikácie liečby bazálnym inzulínom a deintenzifikácia liečby viacerými dennými podaniami inzulínu. Forum Diab 2020; 9(3): 169–175.

4. Uzunlulu M, Oguz A, Arslan Bahadir M et al. C-peptide concentrations in patients with type 2 diabetes treated with insulin. Diabetes Metab Syndr 2019; 13(6): 3099–3104. Dostupné z DOI: <http://dx.doi.org/10.1016/j.dsx.2019.11.010>.

5. Stoekenbroek RM, Rensing KL, Barnelot Moens SJ et al. High daily insulin exposure in patients with type 2 diabetes is associated with increased risk of cardiovascular events. Atherosclerosis 2015; 240(2): 318–323. Dostupné z DOI: <http://dx.doi.org/10.1016/j.atherosclerosis.2015.03.040>.

6. Jin SM, Kim JH, Min KW et al. J Basal-prandial versus premixed insulin in patients with type 2 diabetes requiring insulin intensification after basal insulin optimization: A 24-week randomized non-inferiority trial. Diabetes 2016; 8(3): 405–413. Dostupné z DOI: <http://dx.doi.org/10.1111/1753–0407.12312>.

7. Taneda S, Hyllested-Winge J, Mari-Anne Gall MA et al. J Insulin degludec/insulin aspart versus biphasic insulin aspart 30 twice daily in insulin-experienced Japanese subjects with uncontrolled type 2 diabetes: Subgroup analysis of a Pan-Asian, treat-to-target Phase 3 Trial. Diabetes 2017; 9(3): 243–247. Dostupné z DOI: <http://dx.dpo.org/10.1111/1753–0407.12407>.

8. Rosenstock J, Ahmann AJ, Colon G et al. Advancing Insulin Therapy in Type 2 Diabetes Previously Treated With Glargine Plus Oral Agents. Prandial premixed (insulin lispro protamine suspension/lispro) versus basal/bolus (glargine/lispro) therapy. Diabetes Care 2008; 31(1): 20–25.

9. Rodbard HW, Cariou B, Pieber TR et al. Treatment intensification with an insulin degludec (IDeg)/insulin aspart (IAsp) co-formulation twice daily compared with basal IDeg and prandial IAsp in type 2 diabetes: a randomized, controlled phase III trial. Diabetes Obes Metab 2016; 18(3): 274–280. Dostupné z DOI: <http://dx.doi.org/10.1111/dom.12609>.

10. Liebl A, Prager R, Binz K et al. Comparison of insulin analogue regimens in people with type 2 diabetes mellitus in the PREFER Study: a randomized controlled trial. Diabetes Obes Metab 2009; 11(1): 45–52. Dostupné z DOI: <http://dx.doi.org/10.1111/j.1463–1326.2008.00915.x>.

11. Kaneko S, Chow F, Choi DS et al. Insulin degludec/insulin aspart versus biphasic insulin aspart 30 in Asian patients with type 2 diabetes inadequately controlled on basal or pre-/self-mixed insulin: a 26-week, randomised, treat-to-target trial. Diabetes Res Clin Pract 2015; 107(1): 139–147. Dostupné z DOI: <http://dx.doi.org/10.1016/j.diabres.2014.09.026>.

12. Ilag LL, Kerr L, Malone JK et al. Prandial premixed insulin analogue regimens versus basal insulin analogue regimens in the management of type 2 diabetes: an evidence-based comparison. Clinical Ther 2007; 29 Spec No: 1254–1270.

13. Jude EB, Trescoli C, Emral R et al Effectiveness of premixed insulin to achieve glycaemic control in type 2 diabetes: A retrospective UK cohort study. Diabetes Obes Metab 2021; 23(4): 929–937. Dostupné z DOI: <http://dx.doi.org/10.1111/dom.14298>.

14. Ramachandran A, Mbanya JC, Aschner P et al. Unmet medical needs in people with type 2 diabetes treated by insulin: results from the International Diabetes Management Practices Survey (IDMPS). Abstract 873. Barcelona, EADS 2019. Dostupné z WWW: <https://www.easd.org/virtualmeeting/home>.

15. Martinka E. NEFRITI. Dostupné z WWW: <https://lekar.sdia.sk/ sdia-lekarske-profesne-zdruzenie-aktuality/34/nefriti/>.

16. Jammah AA. Indirect comparison of efficacy and safety of insulin glargine/lixisenatide and insulin degludec/insulin aspart in type 2 diabetes patients not controlled on basal insulin. Primary Care Diabetes 2021; 15(1) 132–137. Dostupné z DOI: <http://dx.doi.org/10.1016/j.pcd.2020.08.004>.

17. Fulcher GR, Christiansen JS, Bantwal G et al. [BOOST: Intensify Premix I Investigators]. Comparison of insulin degludec/insulin aspart and biphasic insulin aspart 30 in uncontrolled, insulin-treated type 2 diabetes: a phase 3a, randomized, treat-to-target trial. Diabetes Care 2014; 37(8): 2084–2090. Dostupné z DOI: <http://dx.doi.org/10.2337/dc13–2908>.

18. Aroda VR, Rosenstock J, Wysham C et al. [LixiLan-L Trial Investigators]. Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide in Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin: The LixiLan-L Randomized Trial. Diabetes Care 2016; 39(11): 1972–1980. Dostupné z DOI:<http://dx.doi.org/10.2337/dc16–1495>.

19. Home P, Blonde L, Kalra S et al Insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi) compared with premix or addition of meal-time insulin to basal insulin in people with type 2 diabetes: A systematic review and Bayesian network meta-analysis. Diabetes Obes Metab 2020; 22(11): 2179–2188. Dostupné z DOI: <http://dx.doi.org/10.1111/dom.14148>.

20. McCrimmon R, Al Sifri S, Emral R et al Advancing therapy with IGlarLixi versus premix BIAsp 30 in basal insulin-treated type 2 diabetes: Design and baseline characteristics of the SoliMix randomized controlled trial. Diabetes Obes Metab 2021; 23(6): 1221–1231. Dostupné z DOI: <http://dx.doi.org/10.1111/dom.14354>.

21. Rosenstock J, Emral R, Sauque-Reyna l et al. Advancing Therapy in Suboptimally Controlled Basal Insulin-Treated Type 2 Diabetes: Clinical Outcomes With IGlarLixi Versus Premix BIAsp 30 in the SoliMix Randomized Controlled Trial. Diabetes Care 2021;[accepted ahead of publication]. Dostupné z DOI: <http://dx.doi.org/ 0.2337/dc21–0393>.

22. [American Diabetes Association]. Standards of Medical Care in Diabetes—2020. Diabetes Care 2020; 43(Suppl 1): S1-S212. Dostupné z DOI: <http://dx.doi.org/10.2337>.

Labels
Diabetology Endocrinology Internal medicine
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