Similar Efficacy and Safety of Basaglar® and Lantus® in Patients with Type 2 Diabetes in Age Groups (< 65 Years, ≥ 65 Years): A Post Hoc Analysis from the ELEMENT-2 Study

Robyn K Pollom, Timothy Costigan, Lyndon B Lacaya, Liza L Ilag, Priscilla A Hollander, Robyn K Pollom, Timothy Costigan, Lyndon B Lacaya, Liza L Ilag, Priscilla A Hollander

Abstract

Introduction: To compare efficacy and safety of Basaglar® [insulin glargine 100 units/mL; LY insulin glargine (LY IGlar)] to Lantus® [insulin glargine 100 units/mL; SA insulin glargine (SA IGlar)] in older (≥ 65 years) or younger (< 65 years) patients with type 2 diabetes (T2D).

Methods: This subgroup analysis of a phase 3, randomized, double-blind, multinational, 24-week study compared LY IGlar and SA IGlar on several clinical efficacy (change in glycated hemoglobin (A1c), basal insulin dose, weight) and safety outcomes (incidence of adverse events, insulin antibodies, hypoglycemia incidence and rates) in patients either ≥ 65 or < 65 years.

Results: Compared with patients aged < 65 years (N = 542), patients aged ≥ 65 years (N = 214) had a significantly longer duration of diabetes; lower baseline A1c and body weight; and body mass index; and were more likely to report prestudy SA IGlar use. Compared to patients < 65 years, patients ≥ 65 years needed a lower basal insulin dose and experienced lower body weight gain. There were no significant treatment-by-age interactions for the clinical efficacy and safety outcomes, indicating that there was no differential treatment effect (LY IGlar vs SA IGlar) for patients ≥ 65 years vs those < 65 years. Moreover, within each age subgroup, LY IGlar and SA IGlar were similar for all clinical efficacy and safety outcomes.

Conclusions: LY IGlar and SA IGlar exhibit similar efficacy and safety in patients with T2D who are ≥ 65 years and in those < 65 years.

Trial registration: ClinicalTrials.gov trial registration: NCT01421459.

Funding: Eli Lilly and Company and Boehringer-Ingelheim.

Keywords: Age; Efficacy; Insulin; Safety; Type 2 diabetes.

Figures

Fig. 1
Fig. 1
Baseline-to-endpoint changes in A1c in patients with type 2 diabetes ≥ 65 and

Fig. 2

Baseline-to-endpoint changes in FBG by…

Fig. 2

Baseline-to-endpoint changes in FBG by SMBG in patients with type 2 diabetes ≥…

Fig. 2
Baseline-to-endpoint changes in FBG by SMBG in patients with type 2 diabetes ≥ 65 and

Fig. 3

Baseline-to-endpoint changes in basal insulin…

Fig. 3

Baseline-to-endpoint changes in basal insulin dose in patients with type 2 diabetes ≥…

Fig. 3
Baseline-to-endpoint changes in basal insulin dose in patients with type 2 diabetes ≥ 65 and

Fig. 4

Overall incidence and rate of…

Fig. 4

Overall incidence and rate of total, documented symptomatic, and nocturnal hypoglycemia in patients…

Fig. 4
Overall incidence and rate of total, documented symptomatic, and nocturnal hypoglycemia in patients with type 2 diabetes ≥ 65 and 
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References
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Fig. 2
Fig. 2
Baseline-to-endpoint changes in FBG by SMBG in patients with type 2 diabetes ≥ 65 and

Fig. 3

Baseline-to-endpoint changes in basal insulin…

Fig. 3

Baseline-to-endpoint changes in basal insulin dose in patients with type 2 diabetes ≥…

Fig. 3
Baseline-to-endpoint changes in basal insulin dose in patients with type 2 diabetes ≥ 65 and

Fig. 4

Overall incidence and rate of…

Fig. 4

Overall incidence and rate of total, documented symptomatic, and nocturnal hypoglycemia in patients…

Fig. 4
Overall incidence and rate of total, documented symptomatic, and nocturnal hypoglycemia in patients with type 2 diabetes ≥ 65 and 
Similar articles
Cited by
References
    1. Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes. Estimates for the year 2000 and projections for 2030. Diabetes Care. 2004;27:1047–1053. doi: 10.2337/diacare.27.5.1047. - DOI - PubMed
    1. American Diabetes Association Standards of medical care in diabetes, older adults. Diabetes Care. 2016;39(Suppl 1):S81–S85. - PubMed
    1. Ligthelm RJ, Kaiser M, Vora J, Yale JF. Insulin use in elderly adults: risk of hypoglycemia and strategies for care. J Am Geriatr Soc. 2012;60:1564–1570. doi: 10.1111/j.1532-5415.2012.04055.x. - DOI - PubMed
    1. Kirkman MS, Briscoe VJ, Clark N, et al. Diabetes in older adults: a consensus report. Diabetes Care. 2012;35:2650–2664. doi: 10.2337/dc12-1801. - DOI - PMC - PubMed
    1. International Diabetes Federation. IDF global guideline for managing older people with type 2 diabetes. 2013. https://www.idf.org/our-activities/advocacy-awareness/resources-and-tool.... Accessed 29 Nov 2017.
Show all 22 references
Associated data
Related information
LinkOut - more resources
Full text links [x]
[x]
Cite
Copy Download .nbib
Format: AMA APA MLA NLM

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MeSH PMC Bookshelf Disclaimer

The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Unauthorized use of these marks is strictly prohibited.

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Fig. 3
Fig. 3
Baseline-to-endpoint changes in basal insulin dose in patients with type 2 diabetes ≥ 65 and

Fig. 4

Overall incidence and rate of…

Fig. 4

Overall incidence and rate of total, documented symptomatic, and nocturnal hypoglycemia in patients…

Fig. 4
Overall incidence and rate of total, documented symptomatic, and nocturnal hypoglycemia in patients with type 2 diabetes ≥ 65 and 
Similar articles
Cited by
References
    1. Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes. Estimates for the year 2000 and projections for 2030. Diabetes Care. 2004;27:1047–1053. doi: 10.2337/diacare.27.5.1047. - DOI - PubMed
    1. American Diabetes Association Standards of medical care in diabetes, older adults. Diabetes Care. 2016;39(Suppl 1):S81–S85. - PubMed
    1. Ligthelm RJ, Kaiser M, Vora J, Yale JF. Insulin use in elderly adults: risk of hypoglycemia and strategies for care. J Am Geriatr Soc. 2012;60:1564–1570. doi: 10.1111/j.1532-5415.2012.04055.x. - DOI - PubMed
    1. Kirkman MS, Briscoe VJ, Clark N, et al. Diabetes in older adults: a consensus report. Diabetes Care. 2012;35:2650–2664. doi: 10.2337/dc12-1801. - DOI - PMC - PubMed
    1. International Diabetes Federation. IDF global guideline for managing older people with type 2 diabetes. 2013. https://www.idf.org/our-activities/advocacy-awareness/resources-and-tool.... Accessed 29 Nov 2017.
Show all 22 references
Associated data
Related information
LinkOut - more resources
Full text links [x]
[x]
Cite
Copy Download .nbib
Format: AMA APA MLA NLM
Fig. 4
Fig. 4
Overall incidence and rate of total, documented symptomatic, and nocturnal hypoglycemia in patients with type 2 diabetes ≥ 65 and 

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