Initiating or Switching to Insulin Degludec/Insulin Aspart in Adults With Type 2 Diabetes in the Philippines

Results from a Prospective, Non-interventional, Real-World Study

Authors

DOI:

https://doi.org/10.15605/jafes.039.02.02

Keywords:

insulin aspart, insulin degludec, insulin aspart drug combination, type 2 diabetes

Abstract

Objectives. Blood glucose levels of the majority of Filipino patients with type 2 diabetes (T2D) remain uncontrolled. Insulin degludec/insulin aspart (IDegAsp) is a fixed‑ratio co-formulation of the long‑acting basal insulin degludec and the rapid-acting prandial insulin aspart. The real-world ARISE (A Ryzodeg® Initiation and Switch Effectiveness) study investigated clinical outcomes across six countries in people with T2D who initiated IDegAsp. This publication presents the clinical outcomes of the Filipino cohort from a subgroup analysis of the ARISE study.

Methodology. This 26-week, open-label, non-interventional study examined outcomes in adults with T2D initiating or switching to IDegAsp (N=185) from other antidiabetic treatments per local clinical guidance.

Results. Compared with baseline, there was a significant improvement in glycated hemoglobin at the end of study (EOS) (estimated difference [ED] −1.4% [95% confidence interval −1.7, −1.1]; P <0.0001). Fasting plasma glucose (ED −46.1 mg/dL [−58.2, −34.0]; P <0.0001) and body weight (ED −1.0 kg [−2.0, −0.1]; P = 0.028) were significantly reduced at EOS compared with baseline. IDegAsp was associated with a decrease in the incidence of self-reported healthcare resource utilization. Adverse events were reported in eight (4.3%) participants.

Conclusions. Initiating or switching to IDegAsp was associated with improved glycemic control, lower body weight, and lower HRU for people with T2D in the Philippines. No new, unexpected AEs were reported.

Downloads

Download data is not yet available.

Author Biographies

Nemencio Nicodemus Jr., Manila Doctors Hospital

Professor

Oliver Allan Dampil

Providence Hospital, Quezon City, Philippines

Mercerose Puno-Rocamora, Novo Nordisk Philippines

Medical Operations and Patient Solutions Manager

Ahsan Shoeb, Novo Nordisk Philippines

Director,  Clinical Medical and Regulatory

References

1. Khan MAB, Hashim MJ, King JK, Govender RD, Mustafa H, Al Kaabi J. Epidemiology of type 2 diabetes – global burden of disease and forecasted trends. J Epidemiol Glob Health. 2020;10(1):107-11. https://pubmed.ncbi.nlm.nih.gov/32175717. PMCID: PMC7310804. https://doi.org/10.2991/jegh.k.191028.001.

2. International Diabetes Federation. Diabetes Atlas, 10th ed. https://diabetesatlas.org/. Accessed December 2, 2022.

3. Republic of the Philippines National Nutrition Council. The obesity epidemic.. Accessed December 2, 2022.

4. Ma RC, Chan JC. Type 2 diabetes in East Asians: Similarities and differences with populations in Europe and the United States. Ann N Y Acad Sci. 2013;1281(1):64-91. https://pubmed.ncbi.nlm.nih.gov/23551121. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3708105. https://doi.org/10.1111/nyas.12098.

5. Paz-Pacheco E, Jimeno C. Diabetes care in the Philippines. J ASEAN Fed Endocr Soc. 2015;30(2):118. https://doi.org/10.15605/jafes.030.02.17.

6. Fojas MC, Lantion-Ang FL, Jimeno CA, et al. Complications and cardiovascular risk factors among newly-diagnosed type 2 diabetics in Manila. Philipp J Int Med. 2009:47(3);99-105. https://drive.google.com/file/d/1KzdeGegJwEn-lPx7-U0tZMAbTKoFZL_P/view.

7. Shah A, Kanaya AM. Diabetes and associated complications in the South Asian population. Curr Cardiol Rep. 2014;16:476. https://pubmed.ncbi.nlm.nih.gov/24643902. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC40263322014. https://doi.org/10.1007/s11886-014-0476-5.

8. Tan GH. Diabetes care in the Philippines. Ann Glob Health. 2015;81(6):863-9. https://pubmed.ncbi.nlm.nih.gov/27108153. https://doi.org/10.1016/j.aogh.2015.10.004.

9. Jimeno C, Sobrepena LM, Mirasol RC. DiabCare 2008: Survey on glycaemic control and the status of diabetes care and complications among patients with type 2 diabetes mellitus in the Philippines. Philipp J Int Med. 2012;50(1):15-22.

10. Jimeno C, Sy RA, De la Pena P, et al. Direct medical costs of type 2 diabetes mellitus in the Philippines: Findings from two hospital databases and physician surveys. BMJ Open. 2021;11:e049737. https://pubmed.ncbi.nlm.nih.gov/34635519. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8506878. https://doi.org/10.1136/bmjopen-2021-049737.

11. Eala MAB, Besa JJ, Mag-Usara RCQ, Arcellana AES, Jimeno CA. Access to insulin and diabetes care in the Philippines. Lancet Diabetes Endocrinol. 2022;10(1):16. https://pubmed.ncbi.nlm.nih.gov/34826392. https://doi.org/10.1016/S2213-8587(21)00309-0.

12. Republic of the Philippines Department of Health. What is insulin access program? https://www.doh.gov.ph/faqs/What-is-Insulin-Access-Program. Accessed December 2, 2022.

13. Republic of the Philippines Department of Health. [Department Circular No 2022–0537] Health Technology Assessment Council (HTAC) Recommendation for the inclusion of insulin glargine and non inclusion of insulin determir for patients with type 1 or type 2 diabetes mellitus in the Philippine National Formulary (PNF). 2022. https://hta.dost.gov.ph/department-circular-no-2022-0537-health-technology-assessment-council-htac-recommendation-for-the-inclusion-of-insulin-glargine-and-non-inclusion-of-insulin-detemir-for-patients-with-type-1-or/. Accessed December 2, 2022.

14. Republic of the Philippines Department of Health. The Philippine National Formulary. https://pharma.doh.gov.ph/the-philippine-national-formulary/. Accessed January 10, 2023.

15. Lambojon K, Chang J, Saeed A, et al. Prices, availability and affordability of medicines with value-added tax exemption: A cross-sectional survey in the Philippines. Int J Environ Res Public Health. 2020;17(14):5242. https://pubmed.ncbi.nlm.nih.gov/32708060. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7400398. https://doi.org/10.3390/ijerph17145242.

16. Ryzodeg® Summary of product characteristics; 2017. https://www.ema.europa.eu/en/documents/product-information/ryzodeg-epar-product-information_en.pdf. Accessed December 2, 2022

17. Franek E, Haluzík M, Canecki Varžić S, et al. Twice daily insulin degludec/insulin aspart provides superior fasting plasma glucose control and a reduced rate of hypoglycaemia compared with biphasic insulin aspart 30 in insulin naïve adults with type 2 diabetes. Diabet Med. 2016;497-505. https://pubmed.ncbi.nlm.nih.gov/26435365. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5063147. https://doi.org/10.1111/dme.12982.

18. 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):139-47. https://pubmed.ncbi.nlm.nih.gov/25498130. https://doi.org/10.1016/j.diabres.2014.09.026.

19. Rodbard HW, Cariou B, Pieber TR, Endahl LA, Zacho J, Cooper JG. 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):274-80. https://pubmed.ncbi.nlm.nih.gov/26592732. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5066701. https://doi.org/10.1111/dom.12609.

20. Onishi Y, Ono Y, Rabøl R, Endahl L, Nakamura S. Superior glycaemic control with once-daily insulin degludec/insulin aspart versus insulin glargine in Japanese adults with type 2 diabetes inadequately controlled with oral drugs: A randomized, controlled phase 3 trial. Diabetes Obes Metab. 2013;15(9):826-32. https://pubmed.ncbi.nlm.nih.gov/23557077. https://doi.org/10.1111/dom.12097.

21. Shigiyama F, Liu L, Nordahl H, Suzuki R, Yamamoto Y, Hirose T. A real-world, prospective, non-interventional study of adults with T2D switching to IDegAsp from glargine U100 or U300 in Japan. Diabetes Ther. 2021;12(9):2405-21. https://pubmed.ncbi.nlm.nih.gov/34304385. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8385001. https://doi.org/10.1007/s13300-021-01117-8.

22. Özçelik S, Çelik M, Vural A, Aydın B, Özçelik M, Gozu H. Outcomes of transition from premixed and intensive insulin therapies to insulin aspart/degludec co formulation in type 2 diabetes mellitus: A real-world experience. Arch Med Sci. 2021;17(1):1–8. https://pubmed.ncbi.nlm.nih.gov/33488849. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7811302. https://doi.org/10.5114/aoms.2020.93264.

23. Fulcher GR, Akhtar S, Al-Jaser SJ, et al. Initiating or switching to insulin degludec/insulin aspart in adults with type 2 diabetes: A real-world, prospective, non interventional study across six countries. Adv Ther. 2022;39(8):3735-48. https://pubmed.ncbi.nlm.nih.gov/35752730. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9244059. https://doi.org/10.1007/s12325-022-02212-3.

24. Fulcher GR, Jarlov H, Piltoft JS, et al. ARISE—a prospective, non-interventional, single-arm study assessing clinical parameters associated with the use of insulin degludec/insulin aspart in patients with type 2 diabetes in real-world settings: Rationale and design. Endocrine. 2021;74(3):530-7. https://pubmed.ncbi.nlm.nih.gov/34637072. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8506473. https://doi.org/10.1007/s12020-021-02887-8.

25. ClinicalTrials.gov. Identifier NCT04042441. A research study, looking at how Ryzodeg® (insulin degludec/insulin aspart) works in people with type 2 diabetes in local clinical practice (ARISE). https://clinicaltrials.gov/ct2/show/NCT04042441. Accessed 10 December 2022.

26. Alvarenga MA, Komatsu WR, de Sa JR, Chacra AR, Dib SA. Clinical inertia on insulin treatment intensification in type 2 diabetes mellitus patients of a tertiary public diabetes center with limited pharmacologic armamentarium from an upper-middle income country. Diabetol Metab Syndr. 2018;10:77. https://pubmed.ncbi.nlm.nih.gov/30386438. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6206856. https://doi.org/10.1186/s13098-018-0382-x

27. Jabbar A, Mohamed WM, Ozaki R, et al. Patterns and trends in insulin initiation and intensification among patients with type 2 diabetes mellitus in the Western Pacific region. Curr Med Res Opin. 2018;34(9):1653-62. https://pubmed.ncbi.nlm.nih.gov/29863422. http://doi.org/10.1080/03007995.2018.1484712.

28. Reid T, Gao L, Gill J, et al. How much is too much? Outcomes in patients using high dose insulin glargine. Int J Clin Pract. 2016;70(1):56-65. https://pubmed.ncbi.nlm.nih.gov/26566714. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4738456. https://doi.org/10.1111/ijcp.12747.

29. Evans M, Schumm-Draeger PM, Vora J, King AB. A review of modern insulin analogue pharmacokinetic and pharmacodynamic profiles in type 2 diabetes: Improvements and limitations. Diabetes Obes Metab. 2011;13(8):677-84. https://pubmed.ncbi.nlm.nih.gov/21410860. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3380549. https://doi.org/10.1111/j.1463-1326.2011.01395.x.

30. Rizvi AA. Treatment of type 2 diabetes with biphasic insulin analogues. Eur Med J Diabetes. 2016;4(1):74-83. https://pubmed.ncbi.nlm.nih.gov/27918600. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5134918.

31. Peyrot M, Barnett AH, Meneghini LF, Schumm-Draeger PM. Insulin adherence behaviours and barriers in the multinational global attitudes of patients and physicians in insulin therapy study. Diabet Med. 2012;29(5):682-9. https://pubmed.ncbi.nlm.nih.gov/22313123. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3433794. https://doi.org/10.1111/j.1464-5491.2012.03605.x.

32. Apovian CM, Okemah J, O’Neil PM. Body weight considerations in the management of type 2 diabetes. Adv Ther. 2019;36(1):44-58. https://pubmed.ncbi.nlm.nih.gov/30465123. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6318231. https://doi.org/10.1007/s12325-018-0824-8.

33. Kalra S, Aamir AH, Raza A, et al. Place of sulfonylureas in the management of type 2 diabetes mellitus in South Asia: A consensus statement. Indian J Endocrinol Metab. 2015;19(5):577-96. https://pubmed.ncbi.nlm.nih.gov/26425465. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4566336. https://doi.org/10.4103/2230-8210.163171.

34. Umpierrez GE, Skolnik N, Dex T, Traylor L, Chao J, Shaefer C. When basal insulin is not enough: A dose–response relationship between insulin glargine 100 units/mL and glycaemic control. Diabetes Obes Metab. 2019;21(6):1305-10. https://pubmed.ncbi.nlm.nih.gov/30724009. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6594069. https://doi.org/10.1111/dom.13653.

35. Higuchi M. Access to diabetes care and medicines in the Philippines. Asia Pac J Public Health. 2010;22(Suppl. 3):96S-102S. https://pubmed.ncbi.nlm.nih.gov/20566540. https://doi.org/10.1177/1010539510373005.

36. World Health Organization. UHC Act in the Philippines: A new dawn for health care. https://www.who.int/philippines/news/feature-stories/detail/uhc-act-in-the-philippines-a-new-dawn-for-health-care. Accessed December 2, 2022.

Downloads

Published

2024-08-04

How to Cite

Nicodemus Jr., N. ., Ang-Golangco, N., Aquitania, G., Ardeña, G. J. R., Dampil, O. A., Fernando, R. E., … Tolentino, M. (2024). Initiating or Switching to Insulin Degludec/Insulin Aspart in Adults With Type 2 Diabetes in the Philippines: Results from a Prospective, Non-interventional, Real-World Study. Journal of the ASEAN Federation of Endocrine Societies, 39(2), 61–69. https://doi.org/10.15605/jafes.039.02.02

Issue

Section

Original Articles

Most read articles by the same author(s)

<< < 1 2 3 4 > >>