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Current Diabetes Reviews

Editor-in-Chief

ISSN (Print): 1573-3998
ISSN (Online): 1875-6417

Mini-Review Article

Use of Second-Generation Basal Insulin Gla-300 in Special Populations: A Narrative Mini-Review

Author(s): Sujoy Ghosh, Sanjay Kalra*, Ganapathi Bantwal and Rakesh Kumar Sahay

Volume 19, Issue 9, 2023

Published on: 20 March, 2023

Article ID: e090123212447 Pages: 10

DOI: 10.2174/1573399819666230109113205

Price: $65

Abstract

Background and Aims: Hypoglycemia and insulin-related adverse events are crucial barriers to effective diabetes management, particularly in the elderly, people with renal impairment, people with diabetes fasting during Ramadan, or people with type 1 diabetes mellitus (T1DM). There is a scarcity of clinical and real-world evidence assessing the effectiveness and safety of insulin glargine 300 U/mL (Gla-300) in these special populations. To understand the entirety of evidence, this mini-review elaborates on the use of Gla-300 in diabetes management among special populations.

Methods: Clinical and real-world evidence related to the use of Gla-300 among special populations with diabetes were retrieved using PUBMED and Google Scholar.

Results: Gla-300 has shown improved glycemic control with stable insulin action and low risk of hypoglycemia in diverse groups with diabetes. It also appears to have an acceptable safety profile during Ramadan fasting. However, adequate monitoring and adjustment of insulin dose on an individual basis should be considered.

Conclusion: Gla-300 is a second-generation basal insulin with proven benefits of reduced risk of hypoglycemia and improved glycemic control in special populations of people with diabetes.

[1]
Zoungas S, Patel A, Chalmers J, et al. Severe hypoglycemia and risks of vascular events and death. N Engl J Med 2010; 363(15): 1410-8.
[http://dx.doi.org/10.1056/NEJMoa1003795] [PMID: 20925543]
[2]
Yun JS, Ko SH. Risk factors and adverse outcomes of severe hypoglycemia in type 2 diabetes mellitus. Diabetes Metab J 2016; 40(6): 423-32.
[http://dx.doi.org/10.4093/dmj.2016.40.6.423] [PMID: 27766794]
[3]
Wysham C, Bhargava A, Chaykin L, et al. Effect of insulin degludec vs. insulin glargine U100 on hypoglycemia in patients with type 2 diabetes: the SWITCH 2 randomized clinical trial. JAMA 2017; 318(1): 45-56.
[http://dx.doi.org/10.1001/jama.2017.7117] [PMID: 28672317]
[4]
Huang ES, Laiteerapong N, Liu JY, John PM, Moffet HH, Karter AJ. Rates of complications and mortality in older patients with diabetes mellitus: the diabetes and aging study. JAMA Intern Med 2014; 174(2): 251-8.
[http://dx.doi.org/10.1001/jamainternmed.2013.12956] [PMID: 24322595]
[5]
Davis TME, Brown SGA, Jacobs IG, Bulsara M, Bruce DG, Davis WA. Determinants of severe hypoglycemia complicating type 2 diabetes: the Fremantle diabetes study. J Clin Endocrinol Metab 2010; 95(5): 2240-7.
[http://dx.doi.org/10.1210/jc.2009-2828] [PMID: 20305006]
[6]
Amiel SA, Dixon T, Mann R, Jameson K. Hypoglycaemia in type 2 diabetes. Diabet Med 2008; 25(3): 245-54.
[http://dx.doi.org/10.1111/j.1464-5491.2007.02341.x] [PMID: 18215172]
[7]
Becker RHA, Nowotny I, Teichert L, Bergmann K, Kapitza C. Low within- and between-day variability in exposure to new insulin glargine 300 U/ml. Diabetes Obes Metab 2015; 17(3): 261-7.
[http://dx.doi.org/10.1111/dom.12416] [PMID: 25425394]
[8]
Bergenstal RM, Bailey TS, Rodbard D, et al. Comparison of insulin glargine 300 units/mL and 100 units/mL in adults with type 1 diabetes: Continuous glucose monitoring profiles and variability using morning or evening injections. Diabetes Care 2017; 40(4): 554-60.
[http://dx.doi.org/10.2337/dc16-0684] [PMID: 28115474]
[9]
Haahr H, Heise T. A review of the pharmacological properties of insulin degludec and their clinical relevance. Clin Pharmacokinet 2014; 53(9): 787-800.
[http://dx.doi.org/10.1007/s40262-014-0165-y] [PMID: 25179915]
[10]
Heise T, Nosek L, Bøttcher SG, Hastrup H, Haahr H. Ultra-long- acting insulin degludec has a flat and stable glucose-lowering effect in type 2 diabetes. Diabetes Obes Metab 2012; 14(10): 944-50.
[http://dx.doi.org/10.1111/j.1463-1326.2012.01638.x] [PMID: 22726241]
[11]
Alsahli M, Gerich JE. Hypoglycemia, chronic kidney disease, and diabetes mellitus. Mayo Clin Proc 2014; 89(11): 1564-71.
[http://dx.doi.org/10.1016/j.mayocp.2014.07.013] [PMID: 25305751]
[12]
Moen MF, Zhan M, Hsu VD, et al. Frequency of hypoglycemia and its significance in chronic kidney disease. Clin J Am Soc Nephrol 2009; 4(6): 1121-7.
[http://dx.doi.org/10.2215/CJN.00800209] [PMID: 19423569]
[13]
Alsahli M, Gerich J. Hypoglycemia in patients with diabetes and renal disease. J Clin Med 2015; 4(5): 948-64.
[http://dx.doi.org/10.3390/jcm4050948] [PMID: 26239457]
[14]
Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2015; 38(1): 140-9.
[http://dx.doi.org/10.2337/dc14-2441] [PMID: 25538310]
[15]
KDOQI Clinical practice guideline for diabetes and CKD: 2012 Update. Am J Kidney Dis 2012; 60(5): 850-86.
[http://dx.doi.org/10.1053/j.ajkd.2012.07.005] [PMID: 23067652]
[16]
Pathak RD, Schroeder EB, Seaquist ER, et al. Severe hypoglycemia requiring medical intervention in a large cohort of adults with diabetes receiving care in U.S. Integrated Health Care Delivery Systems:2005-2011. Diabetes Care 2016; 39(3): 363-70.
[http://dx.doi.org/10.2337/dc15-0858] [PMID: 26681726]
[17]
Javier Escalada F, Halimi S, Senior PA, et al. Glycaemic control and hypoglycaemia benefits with insulin glargine 300 U/mL extend to people with type 2 diabetes and mild-to-moderate renal impairment. Diabetes Obes Metab 2018; 20(12): 2860-8.
[http://dx.doi.org/10.1111/dom.13470] [PMID: 30003642]
[18]
Haluzík M, Cheng A, Müller-Wieland D, et al. Differential glycaemic control with basal insulin glargine 300 U/mL versus degludec 100 U/mL according to kidney function in type 2 diabetes: A subanalysis from the BRIGHT trial. Diabetes Obes Metab 2020; 22(8): 1369-77.
[http://dx.doi.org/10.1111/dom.14043] [PMID: 32243043]
[19]
Mauricio D, Gourdy P, Bonadonna RC, et al. Glycaemic control with insulin glargine 300 U/ml in individuals with type 2 diabetes and chronic kidney disease: A REALI European Pooled Data Analysis. Diabetes Ther 2021; 12(4): 1159-74.
[http://dx.doi.org/10.1007/s13300-021-01031-z] [PMID: 33751403]
[20]
Sullivan SD, Bailey TS, Roussel R, et al. Clinical outcomes in real-world patients with type 2 diabetes switching from first- to second-generation basal insulin analogues: Comparative effectiveness of insulin glargine 300 units/mL and insulin degludec in the DELIVER D+ cohort study. Diabetes Obes Metab 2018; 20(9): 2148-58.
[http://dx.doi.org/10.1111/dom.13345] [PMID: 29938887]
[21]
Sullivan SD, Freemantle N, Menon AA, et al. High Hypoglycemia Risk Patients with Type 2 Diabetes on First Generation Basal Insulins (BIs) in the us Have a Lower Risk of Hypoglycemia after 1 year Following Switch to Insulin Glargine 300 U/mL versus First Generation BIs (DELIVER – High Risk). Poster 133 LB, American Diabetes Association (ADA) 79th Scientific Sessions, San Francisco, CA, US. June 7 11, 2019. Available from: https://ada.scientificposters.com/ (Accessed on: 10 Oct 2021).
[22]
Pettus J, Roussel R, Liz Zhou F, et al. Rates of hypoglycemia predicted in patients with type 2 diabetes on insulin glargine 300 U/ml versus first- and second-generation basal insulin analogs: the real-world lightning study. Diabetes Ther 2019; 10(2): 617-33.
[http://dx.doi.org/10.1007/s13300-019-0568-8] [PMID: 30767173]
[23]
Meneghini L, Cheng A, Evenou P, et al. 1038-P: Insulin glargine 300 U/mL (gla-300) vs. first-generation standard-of-care basal insulin analogs (SOC-BI) in insulin-naïve patients with type 2 diabetes (T2D): impact of renal function on the outcomes of the randomized pragmatic real-life achieve control study. Diabetes 2020; 69(Supplement 1): 1038-P.
[http://dx.doi.org/10.2337/db20-1038-P]
[24]
ClinicalTrials.gov Identifier: NCT03703869: Twelve -month study observing how insulin-naïve patients with type 2 diabetes mellitus manage diabetes using toujeo® after oral antidiabetic drug failure, the side effect of toujeo®, and the cost. (ATOS). Available from: https://clinicaltrials.gov/ct2/show/NCT03703869 (Accessed on: 22 October 2021).
[25]
Tirosh A, Khan N, Vargas-Uricoechea H, et al. 743-P: Real-world effectiveness and safety of insulin glargine 300 U/mL (gla-300) in insulin-naïve people with type 2 diabetes (T2DM) and renal impairment (RI): a subgroup analysis of the ATOS study. Diabetes 2021; 70(S1): 743-P.
[http://dx.doi.org/10.2337/db21-743-P]
[26]
Kawaguchi Y, Sawa J, Hamai C, Kumeda Y. Differential effect of hypoalbuminemia on hypoglycemia on type 2 diabetes patients treated with insulin glargine 300 U/mL and insulin degludec. Diabetes Ther 2019; 10(4): 1535-41.
[http://dx.doi.org/10.1007/s13300-019-0654-y] [PMID: 31228089]
[27]
Abdelhafiz AH, Rodríguez-Mañas L, Morley JE, Sinclair AJ. Hypoglycemia in older people - a less well recognized risk factor for frailty. Aging Dis 2015; 6(2): 156-67.
[http://dx.doi.org/10.14336/AD.2014.0330] [PMID: 25821643]
[28]
Kirkman MS, Briscoe VJ, Clark N, et al. Diabetes in older adults. Diabetes Care 2012; 35(12): 2650-64.
[http://dx.doi.org/10.2337/dc12-1801] [PMID: 23100048]
[29]
Escalada J, Liao L, Pan C, Wang H, Bala M. Outcomes and healthcare resource utilization associated with medically attended hypoglycemia in older patients with type 2 diabetes initiating basal insulin in a US managed care setting. Curr Med Res Opin 2016; 32(9): 1557-65.
[http://dx.doi.org/10.1080/03007995.2016.1189893] [PMID: 27173946]
[30]
Ritzel R, Harris SB, Baron H, et al. A randomized controlled trial comparing efficacy and safety of insulin glargine 300 units/ml versus 100 Units/mL in older people with type 2 diabetes: results from the senior study. Diabetes Care 2018; 41(8): 1672-80.
[http://dx.doi.org/10.2337/dc18-0168] [PMID: 29895556]
[31]
Yale JF, Aroda VR, Charbonnel B, et al. Glycaemic control and hypoglycaemia risk with insulin glargine 300 U/mL versus glargine 100 U/mL: A patient-level meta-analysis examining older and younger adults with type 2 diabetes. Diabetes Metab 2020; 46(2): 110-8.
[http://dx.doi.org/10.1016/j.diabet.2018.10.002] [PMID: 30366067]
[32]
Munshi MN, Gill J, Chao J, Nikonova E, Patel M. Insulin glargine 300 u/ml is associated with less weight gain while maintaining glycemic control and low risk of hypoglycemia compared with insulin glargine 100 u/ml in an aging population with type 2 diabetes. Endocr Pract 2018; 24(2): 143-9.
[http://dx.doi.org/10.4158/EP171922.OR] [PMID: 29106816]
[33]
Charbonnel B, Aroda VR, Westerbacka J, et al. #131-LB. Differences in HbA1c reduction between insulin glargine 300 U/mL (Gla-300) and insulin degludec 100 U/mL (IDeg-100) in adults ≥70 years of age with T2DM in the bright trial. ADA 2019. Diabetes 2019; 68 (Supplement 1): 131-LB.
[http://dx.doi.org/10.2337/db19-131-LB]
[34]
Bolli GB, Cheng A, Charbonnel B, et al. Glycaemic control and hypoglycaemia risk with insulin glargine 300 U/mL and insulin degludec 100 U/mL in older participants in the BRIGHT trial. Diabetes Obes Metab 2021; 23(7): 1588-93.
[http://dx.doi.org/10.1111/dom.14372] [PMID: 33687748]
[35]
Bailey TS, Wu J, Zhou FL, et al. Switching to insulin glargine 300 units/mL in real-world older patients with type 2 diabetes (DELIVER 3). Diabetes Obes Metab 2019; 21(11): 2384-93.
[http://dx.doi.org/10.1111/dom.13818] [PMID: 31264346]
[36]
Bonadonna RC, Mauricio D, Müller-Wieland D, et al. Impact of age on the effectiveness and safety of insulin glargine 300 U/ml: results from the reali European pooled data analysis. Diabetes Ther 2021; 12(4): 1073-97.
[http://dx.doi.org/10.1007/s13300-021-01030-0] [PMID: 33650085]
[37]
Hirose T, Odawara M, Matsuhisa M, et al. Risk of hypoglycemia in Japanese people with type 2 diabetes mellitus who initiated or switched to insulin glargine 300 U/mL: A subgroup analysis of 12-month post-marketing surveillance study (X-STAR study). Diabetes Res Clin Pract 2021; 172: 108647.
[http://dx.doi.org/10.1016/j.diabres.2020.108647] [PMID: 33359753]
[38]
Galstyan GR, Tirosh A, Vargas-Uricoechea H, et al. 194-OR: Real-world effectiveness and safety of insulin glargine 300 U/mL (Gla-300) in older adults (≥70 Years) with type 2 diabetes (T2DM): A subgroup analysis of the ATOS study. Diabetes 2021; 70 (Supplement 1): 194-OR.
[http://dx.doi.org/10.2337/db21-194-OR]
[39]
Bailey TS, Pettus J, Roussel R, et al. Morning administration of 0.4 U/kg/day insulin glargine 300 U/mL provides less fluctuating 24-hour pharmacodynamics and more even pharmacokinetic profiles compared with insulin degludec 100 U/mL in type 1 diabetes. Diabetes Metab 2018; 44(1): 15-21.
[http://dx.doi.org/10.1016/j.diabet.2017.10.001] [PMID: 29153485]
[40]
Lucidi P, Candeloro P, Cioli P, et al. Pharmacokinetic and pharmacodynamic head-to-head comparison of clinical, equivalent doses of insulin glargine 300 units · mL−1 and insulin degludec 100 units · mL−1 in type 1 diabetes. Diabetes Care 2021; 44(1): 125-32.
[http://dx.doi.org/10.2337/dc20-1033] [PMID: 33444161]
[41]
Porcellati F, Lucidi P, Candeloro P, et al. Pharmacokinetics, pharmacodynamics, and modulation of hepatic glucose production with insulin glargine U300 and glargine U100 at steady state with individualized clinical doses in type 1 diabetes. Diabetes Care 2019; 42(1): 85-92.
[http://dx.doi.org/10.2337/dc18-0706] [PMID: 30305345]
[42]
Heise T, Kaplan K, Haahr HL. Day-to-day and within-day variability in glucose-lowering effect between insulin degludec and insulin glargine (100 U/mL and 300 U/mL): a comparison across studies. J Diabetes Sci Technol 2018; 12(2): 356-63.
[http://dx.doi.org/10.1177/1932296817731422] [PMID: 28946756]
[43]
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): 2217-25.
[http://dx.doi.org/10.2337/dc15-0249] [PMID: 26084341]
[44]
Danne T, Matsuhisa M, Sussebach C, et al. Lower risk of severe hypoglycaemia with insulin glargine 300 U/ mL versus glargine 100 U/ mL in participants with type 1 diabetes: a meta-analysis of 6-month phase 3 clinical trials. Diabetes Obes Metab 2020; 22(10): 1880-5.
[http://dx.doi.org/10.1111/dom.14109] [PMID: 32515543]
[45]
Danne T, Tamborlane WV, Malievsky OA, et al. Efficacy and safety of insulin glargine 300 Units/mL (gla-300) versus insulin glargine 100 Units/mL (gla-100) in children and adolescents (6–17 years) with type 1 diabetes: results of the edition junior randomized controlled trial. Diabetes Care 2020; 43(7): 1512-9.
[http://dx.doi.org/10.2337/dc19-1926] [PMID: 32430458]
[46]
Matsuhisa M, Koyama M, Cheng X, et al. New insulin glargine 300 U/ml versus glargine 100 U/ml in Japanese adults with type 1 diabetes using basal and mealtime insulin: glucose control and hypoglycaemia in a randomized controlled trial (EDITION JP 1). Diabetes Obes Metab 2016; 18(4): 375-83.
[http://dx.doi.org/10.1111/dom.12619] [PMID: 26662964]
[47]
Mathieu C, Weisnagel SJ, Stella P, Bruhwyler J, Alexandre K. Impact of switching from twice-daily basal insulin to once-daily insulin glargine 300 U/mL in people with type 1 diabetes on basal–bolus insulin: phase 4 optimize study. Diabetes Ther 2020; 11(2): 495-507.
[http://dx.doi.org/10.1007/s13300-019-00749-1] [PMID: 31925722]
[48]
Rea RR, Dib SA, de Paula MA, et al. P146: Impact of switching from twice-daily (bid) basal insulin to once-daily (OD) insulin glargine 300 U/ml (GLA-300) in patients with type 1 diabetes (T1D)-phase 4 TOP1 trial, Brazilian cohort. 22nd Brazilian Diabetes Society Congress. Diabetol Metab Syndr 2019; 11(S1): 146.
[http://dx.doi.org/10.1186/s13098-019-0473-3]
[49]
Fritsche A, Pscherer S, Anderten H, Pegelow K, Seufert J, Pfohl M. Switching to insulin glargine 300 U/mL (Gla-300) improves glycemic control after failure of basal-bolus therapy (BBT) with other basal insulins (BI) in patients (Pts) with type 1 diabetes (T1DM). Diabetes 2018; 67(S1): 1031-P.
[http://dx.doi.org/10.2337/db18-1031-P]
[50]
Pujante AP, Rodríguez ER, García UF, et al. Experience after switching from insulin glargine U100 to glargine U300 in patients with type 1 diabetes mellitus. A study after one year of treatment in real life. Endocrinología, Diabetes y Nutrición 2019; 66(4): 210-6.
[http://dx.doi.org/10.1016/j.endien.2018.09.002] [PMID: 30559088]
[51]
Quansah KA, Sauriol L, Kukaswadia AA, Bremner S, Millson B. Persistence with insulin glargine 300 IU/mL compared with other basal insulins-a canadian retrospective cohort study. Diabetes 2018; 67(Suppl. 1): 1786-P.
[http://dx.doi.org/10.2337/db18-1786-P]
[52]
van Mark G, Lanzinger S, Sziegoleit S, et al. Characteristics of patients with type-1 or type-2 diabetes receiving insulin glargine u300: an analysis of 7268 patients based on the DPV and DIVE Registries. Adv Ther 2019; 36(7): 1628-41.
[http://dx.doi.org/10.1007/s12325-019-00983-w] [PMID: 31119688]
[53]
Pang T, Bain SC, Black RNA, et al. A multicentre, UK, retrospective, observational study to assess the effectiveness of insulin glargine 300 units/ml in treating people with Type 1 diabetes mellitus in routine clinical practice (SPARTA). Diabet Med 2019; 36(1): 110-9.
[http://dx.doi.org/10.1111/dme.13847] [PMID: 30362181]
[54]
Oriot P, Jérémie W, Buysschaert M. Outcomes of glycemic control in type 1 diabetic patients switched from basal insulin glargine 100 U/ml to glargine 300 U/ml in real life. Expert Rev Endocrinol Metab 2018; 13(3): 167-71.
[http://dx.doi.org/10.1080/17446651.2018.1469405] [PMID: 30058899]
[55]
Abitbol A, Brown RE, Jiandani D, Sauriol L, Aronson R. Real-world health outcomes of insulin glargine 300 U/mL vs. insulin glargine 100 U/mL in adults with type 1 and type 2 diabetes in the canadian LMC diabetes patient registry: The REALITY Study. Can J Diabetes 2019; 43(7): 504-509.e1.
[http://dx.doi.org/10.1016/j.jcjd.2019.04.012] [PMID: 31256905]
[56]
Laviola L, Porcellati F, Bruttomesso D, Larosa M, Rossi MC, Nicolucci A. Comparative effectiveness of switching from first-generation basal insulin to glargine 300 U/ml or degludec 100 U/ml in type 1 diabetes: The restore-1 study. Diabetes Ther 2021; 12(2): 509-25.
[http://dx.doi.org/10.1007/s13300-020-00982-z] [PMID: 33351177]
[57]
Conget I, Mangas MÁ, Morales C, et al. Effectiveness and safety of insulin glargine 300 U/mL in comparison with insulin degludec 100 u/ml evaluated with continuous glucose monitoring in adults with type 1 diabetes and suboptimal glycemic control in routine clinical practice: the onecare study. Diabetes Ther 2021; 12(11): 2993-3009.
[http://dx.doi.org/10.1007/s13300-021-01153-4] [PMID: 34599749]
[58]
Matsuhisa M, Koyama M, Cheng X, et al. Sustained glycaemic control and less nocturnal hypoglycaemia with insulin glargine 300U/mL compared with glargine 100 U/mL in Japanese adults with type 1 diabetes (EDITION JP 1 randomised 12-month trial including 6-month extension). Diabetes Res Clin Pract 2016; 122: 133-40.
[http://dx.doi.org/10.1016/j.diabres.2016.10.002] [PMID: 27835765]
[59]
Matsuhisa M, Odawara M, Hirose T, et al. Real-world data on the use of insulin glargine 300 U/mL in Japanese patients with type 1 diabetes: twelve-month results from a post-marketing surveillance study (X-STAR study). Expert Opin Pharmacother 2021; 22(2): 249-56.
[http://dx.doi.org/10.1080/14656566.2020.1810665] [PMID: 32840155]
[60]
Home PD, Bergenstal RM, Bolli GB, et al. Glycaemic control and hypoglycaemia during 12 months of randomized treatment with insulin glargine 300 U/mL versus glargine 100 U/mL in people with type 1 diabetes (EDITION 4). Diabetes Obes Metab 2018; 20(1): 121-8.
[http://dx.doi.org/10.1111/dom.13048] [PMID: 28661585]
[61]
Hassanein M, Buyukbese MA, Malek R, et al. Real-world safety and effectiveness of insulin glargine 300 U/mL in participants with type 2 diabetes who fast during Ramadan: The observational ORION study. Diabetes Res Clin Pract 2020; 166: 108189.
[http://dx.doi.org/10.1016/j.diabres.2020.108189] [PMID: 32360709]

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