Effect of Insulin Degludec Versus Insulin Glargine U100 on Hypoglycemia in Hispanic Patients With Type 2 Diabetes: Results From the SWITCH 2 Trial

Louis Chaykin, Anuj Bhargava, Raymond de la Rosa, Carol H Wysham, Lone Nørgård Troelsen, Signe H Østoft, Athena Philis-Tsimikas, Louis Chaykin, Anuj Bhargava, Raymond de la Rosa, Carol H Wysham, Lone Nørgård Troelsen, Signe H Østoft, Athena Philis-Tsimikas

Abstract

IN BRIEF Hispanic patients with type 2 diabetes have poorer glycemic control and are at higher risk of severe diabetes complications and mortality than non-Hispanic white patients. This post hoc analysis investigated the safety and efficacy of insulin degludec versus insulin glargine 100 units/mL (glargine U100) in the Hispanic patient subpopulation from the SWITCH 2 trial. In Hispanic patients, hypoglycemia was consistently lower and nocturnal hypoglycemia was significantly lower with degludec versus glargine U100 at similar levels of glycemic control. Overall, results in Hispanic patients in SWITCH 2 were consistent with those in non-Hispanic patients.

Figures

FIGURE 1.
FIGURE 1.
ERRs (degludec/glargine U100) of hypoglycemia in Hispanic and non-Hispanic patients during the SWITCH 2 trial. Full analysis set. *Only four episodes of severe hypoglycemia were reported in the maintenance period, which precluded statistical analysis. P values derived using a Poisson Model with logarithm of the exposure time (100 years) as offset; estimates adjusted for treatment, period, sequence, and dosing time as fixed effects and patient as random effects. BG, blood glucose.
FIGURE 2.
FIGURE 2.
Glycemic control in Hispanic and non-Hispanic patients during the SWITCH 2 trial. Full analysis set. A and B: A1C. C and D: FPG. Estimated treatment differences (ETDs; degludec – glargine U100) for change in A1C after 32 weeks of treatment are derived from a mixed model for repeated measures with an unstructured covariance matrix including sex, antidiabetic therapy at screening, visit and dosing time as fixed effects, and age and baseline A1C as covariates. FPG, fasting plasma glucose.

References

    1. American Diabetes Association Economic costs of diabetes in the U.S. in 2012. Diabetes Care 2013;36:1033–1046
    1. Menke A, Casagrande S, Geiss L, Cowie CC. Prevalence of and trends in diabetes among adults in the United States, 1988–2012. JAMA 2015;314:1021–1029
    1. Centers for Disease Control and Prevention Table 40. Diabetes prevalence and glycemic control among adults aged 20 and over, by sex, age, and race and Hispanic origin: United States, selected years 1988–1994 through 2011–2014 [article online], 2015. Available from . Accessed 21 October 2017
    1. Narayan KM, Boyle JP, Thompson TJ, Sorensen SW, Williamson DF. Lifetime risk for diabetes mellitus in the United States. JAMA 2003;290:1884–1890
    1. Ferrannini E, Gastaldelli A, Matsuda M, et al. . Influence of ethnicity and familial diabetes on glucose tolerance and insulin action: a physiological analysis. J Clin Endocrinol Metab 2003;88:3251–3257
    1. Haffner SM, D’Agostino R, Saad MF, et al. . Increased insulin resistance and insulin secretion in nondiabetic African-Americans and Hispanics compared with non-Hispanic whites. The Insulin Resistance Atherosclerosis Study. Diabetes 1996;45:742–748
    1. Ford ES, Maynard LM, Li C. Trends in mean waist circumference and abdominal obesity among US adults, 1999–2012. JAMA 2014;312:1151–1153
    1. Caballero AE. Understanding the Hispanic/Latino patient. Am J Med 2011;124:S10–S15
    1. United States Census Bureau Quick facts: United States [article online]. Available from . Accessed 8 May 2017
    1. Colby SL, Ortman JM. Projections of the size and composition of the U.S. population: 2014 to 2060. In: Current Population Reports. Washington, DC, U.S. Census Bureau, 2015
    1. Handelsman Y, Bloomgarden ZT, Grunberger G, et al. . American Association of Clinical Endocrinologists and American College of Endocrinology clinical practice guidelines for developing a diabetes mellitus comprehensive care plan—2015. Endocr Pract 2015;21(Suppl. 1):S1–S87
    1. American Diabetes Association Introduction. In Standards of Medical Care in Diabetes—2017. Diabetes Care 2017;40(Suppl. 1):S1–S2
    1. Schneiderman N, Llabre M, Cowie CC, et al. . Prevalence of diabetes among Hispanics/Latinos from diverse backgrounds: the Hispanic Community Health Study/Study of Latinos (HCHS/SOL). Diabetes Care 2014;37:2233–2239
    1. McWilliams JM, Meara E, Zaslavsky AM, Ayanian JZ. Differences in control of cardiovascular disease and diabetes by race, ethnicity, and education: U.S. trends from 1999 to 2006 and effects of medicare coverage. Ann Intern Med 2009;150:505–515
    1. Zhang X, Saaddine JB, Chou CF, et al. . Prevalence of diabetic retinopathy in the United States, 2005–2008. JAMA 2010;304:649–656
    1. Sinha SK, Shaheen M, Rajavashisth TB, Pan D, Norris KC, Nicholas SB. Association of race/ethnicity, inflammation, and albuminuria in patients with diabetes and early chronic kidney disease. Diabetes Care 2014;37:1060–1068
    1. Lavery LA, Armstrong DG, Wunderlich RP, Tredwell J, Boulton AJ. Diabetic foot syndrome: evaluating the prevalence and incidence of foot pathology in Mexican Americans and non-Hispanic whites from a diabetes disease management cohort. Diabetes Care 2003;26:1435–1438
    1. Dominguez K, Penman-Aguilar A, Chang MH, et al. . Vital signs: leading causes of death, prevalence of diseases and risk factors, and use of health services among Hispanics in the United States: 2009–2013. Morb Mortal Wkly Rep 2015;64:469–478
    1. Polonsky WH, Fisher L, Guzman S, Villa-Caballero L, Edelman SV. Psychological insulin resistance in patients with type 2 diabetes: the scope of the problem. Diabetes Care 2005;28:2543–2545
    1. Campos C. Addressing cultural barriers to the successful use of insulin in Hispanics with type 2 diabetes. South Med J 2007;100:812–820
    1. Shi L, Shao H, Zhao Y, Thomas NA. Is hypoglycemia fear independently associated with health-related quality of life? Health Qual Life Outcomes 2014;12:167.
    1. Gutiérrez R, Ferro A, Caballero A. Myths and misconceptions about insulin therapy among Latinos/Hispanics with diabetes: a fresh look at an old problem. J Diabetes Metab 2015;6
    1. Heise T, Nosek L, Bottcher 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;14:944–950
    1. 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;318:45–56
    1. Ratner R, Gough SC, Mathieu C, et al. . Hypoglycaemia risk with insulin degludec compared with insulin glargine in type 2 and type 1 diabetes: a pre-planned meta-analysis of phase 3 trials. Diabetes Obes Metab 2013;15:175–184
    1. Seaquist ER, Anderson J, Childs B, et al. . Hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and the Endocrine Society. Diabetes Care 2013;36:1384–1395
    1. Marso SP, McGuire DK, Zinman B, et al. . Efficacy and safety of degludec versus glargine in type 2 diabetes. N Engl J Med 2017;377:723–732
    1. 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;15:826–832
    1. Warren ML, Chaykin LB, Jabbour S, et al. . Insulin degludec 200 units/mL is associated with lower injection frequency and improved patient-reported outcomes compared with insulin glargine 100 units/mL in patients with type 2 diabetes requiring high-dose insulin. Clin Diabetes 2017;35:90–95
    1. Cowie CC, Rust KF, Ford ES, et al. . Full accounting of diabetes and pre-diabetes in the U.S. population in 1988-1994 and 2005-2006. Diabetes Care 2009;32:287–294
    1. Fernandez A, Quan J, Moffet H, Parker MM, Schillinger D, Karter AJ. Adherence to newly prescribed diabetes medications among insured Latino and white patients with diabetes. JAMA Intern Med 2017;177:371–379
    1. Ginde AA, Espinola JA, Camargo CA Jr. Trends and disparities in U.S. emergency department visits for hypoglycemia, 1993-2005. Diabetes Care 2008;31:511–513
    1. Barendse S, Singh H, Frier BM, Speight J. The impact of hypoglycaemia on quality of life and related patient-reported outcomes in type 2 diabetes: a narrative review. Diabet Med 2012;29:293–302
    1. Brod M, Christensen T, Thomsen TL, Bushnell DM. The impact of non-severe hypoglycemic events on work productivity and diabetes management. Value Health 2011;14:665–671
    1. Bron M, Marynchenko M, Yang H, Yu AP, Wu EQ. Hypoglycemia, treatment discontinuation, and costs in patients with type 2 diabetes mellitus on oral antidiabetic drugs. Postgrad Med 2012;124:124–132

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