Hypoglycemia After Initiation of Basal Insulin in Patients with Type 2 Diabetes in the United States: Implications for Treatment Discontinuation and Healthcare Costs and Utilization

Abstract

IntroductionHypoglycemia and fear of hypoglycemia may contribute to basal insulin discontinuation, poor glycemic control, and increased healthcare burden in patients with type 2 diabetes (T2D). This study aimed to determine the impact of hypoglycemia soon after basal insulin initiation on treatment discontinuation and economic outcomes in patients with T2D.MethodsHypoglycemic events within 6 months of basal insulin initiation were identified using retrospective cohort data from patients with T2D, at least 18 years of age, initiated on basal insulin therapy in the Clinformatics™ Data Mart for Multiplan claims database from January 1, 2008, through August 31, 2012. Data were adjusted for baseline characteristics. Discontinuation was established for patients with 12-month follow-up data, while discontinuation risk was assessed in the extended analysis (6- to 24-month follow-up) by Cox regression analysis. Healthcare use and costs were determined.ResultsOf 55,608 patients, 4.5% experienced hypoglycemia within 6 months of basal insulin initiation. Patients with hypoglycemia were more likely to discontinue basal insulin within 12 months of initiation (79.0% vs. 74.2%; P < 0.001). Data, adjusted for baseline characteristics such as age, any baseline hypoglycemia, and use of oral antidiabetes drugs, showed that patients with hypoglycemia had a greater risk of discontinuation (hazard ratio 1.16; 95% confidence interval 1.03, 1.32; P = 0.0164), were more likely to have a hospitalization (41.0% vs. 24.3%; P < 0.001) or an ED visit (55.8% vs. 35.1%; P < 0.001), and had higher diabetes-related ($13,662 vs. $7506; P < 0.001) and all-cause ($30,719 vs. $19,079; P < 0.001) healthcare costs.ConclusionsUS patients with T2D who experienced hypoglycemia within 6 months of basal insulin initiation were more likely to discontinue treatment, accompanied by a greater healthcare burden.FundingSanofi US, Inc.Electronic supplementary materialThe online version of this article (doi:10.1007/s12325-017-0592-x) contains supplementary material, which is available to authorized users.

A comparative effectiveness study of degludec and insulin glargine 300 U/mL in insulin‐naïve patients with type 2 diabetes

“…In the present real‐world study, degludec treatment resulted in greater reductions in the rate and likelihood of hypoglycaemia compared with glargine U300 treatment, findings that probably contributed to the ability of patients to reach lower HbA1c and to persist with the original insulin therapy with degludec vs glargine U300. Indeed, in real‐world clinical practice, when hypoglycaemia occurs during the first 6 months of treatment, it has been demonstrated that the risk of discontinuation, as well as the risk of hospitalization and augmented healthcare costs, increases . Although the financial impact of insulins is also considered to be a major driver of treatment discontinuation because of access to insurance schemes requiring reduced or no copayments, in terms of differentiation among insulins, hypoglycaemia may be a more important driver.…”

Hypoglycaemia risk in the first 8 weeks of titration with insulin glargine 100 U/mL in previously insulin‐naive individuals with type 2 diabetes mellitus

“…[10][11][12][13] A limitation of this post-hoc analysis is that it describes observations associated with retrospectively defined hypoglycaemia subgroups and, by necessity, has used a descriptive analysis and, therefore, cannot demonstrate any causality of these associations. Analyses used descriptive statistics and results are shown as mean (standard deviation) unless stated otherwise.…”

“…[10][11][12][13] A limitation of this post-hoc analysis is that it describes observations associated with retrospectively defined hypoglycaemia subgroups and, by necessity, has used a descriptive analysis and, therefore, cannot demonstrate any causality of these associations.Confounding factors other than BMI, weight or fasting C-peptide level may also have contributed to the difference in hypoglycaemia risk during Gla-100 titration.In summary, the present retrospective analysis of hypoglycaemia risk in a large sample of individuals with T2DM who are initiating Gla-100 after inadequate glycaemic control with oral therapy has identified individuals who required or received different insulin doses to reach a similar level of glycaemic control, but who also differed considerably in characteristics associated with hypoglycaemia risk during titration. Changes in glycaemia, body weight and insulin dose from baseline to Weeks 12 and 24 were analysed.…”

Reporting of hypoglycaemia in clinical trials of basal insulins: A need for consensus

“…During the first few months of a new therapy, some recipients will experience problems. Indeed, approximately 5% of individuals with T2DM experience hypoglycaemia within 6 months of initiation of insulin therapy . When hypoglycaemia occurs soon after insulin therapy is commenced, individuals are more likely to discontinue BI therapy within the first 12 months (hazard ratio, 1.16; 95% CI, 1.03, 1.32; P = .016) .…”