Abstract
Insulin glargine 300 U/mL (Gla-300) is a new generation basal insulin product that has been demonstrated to have more stable pharmacokinetic and pharmacodynamic characteristics than insulin glargine 100 U/mL (Gla-100). To evaluate the real-world benefits of Gla-300 in reducing nocturnal fluctuations in blood glucose levels and nocturnal hypoglycemia, 10 Taiwanese patients using Gla-100 for insulin therapy were switched to Gla-300 and continuous glucose monitoring (CGM) was applied at nighttime to monitor changes to nocturnal glycemic variability parameters. Glycemic variability parameters measured to assess between- and within-night glycemic variability included mean 6-hour nocturnal (00:00–6:00 AM) glucose levels, standard deviation (SD), and coefficient of variance (CV) of mean nocturnal glucose levels and mean glucose excursion (MAGE). In this study, Gla-300 demonstrated comparable glycemic efficacy to Gla-100 and the potential to further reduce nocturnal hypoglycemia risk. Overall, nocturnal glycemic variability parameters measured during the Gla-300 treatment period were numerically smaller than those measured during the Gla-100 treatment phase although statistical significance was not reached. In terms of within-night glucose management, SD and CV values of mean nocturnal glucose levels were found to be statistically lower during the Gla-300 treatment phase than the Gla-100 treatment phase on nights individuals displayed normal blood glucose level readings at the beginning of the night. In summary, this study represents the first of its kind from Taiwan to evaluate the real-world clinical benefits of switching Taiwanese diabetes patients from Gla-100 to Gla-300 insulin therapy in reducing nighttime glucose variability by means of CGM.
Highlights
Insulin therapy is recommended by clinical guidelines as the primary strategy for the management of type 1 diabetes (T1DM) and as the second-line therapy for type 2 diabetes (T2DM) [1,2,3]
In this case-series study, two rounds of nocturnal continuous glucose monitoring (CGM) were performed in a total of 10 diabetes patients who visited the clinic between April 2016 and August 2016 when they were being clinically switched from glargine 100 U/mL (Gla-100) (Lantus, Sanofi, Paris, France) to glargine 300 U/mL (Gla-300) (Toujeo, Sanofi, Paris, France) for basal insulin therapy. 8 patients were with T1DM, and 2 patients were with T2DM
Consistent with other Gla-100 to Gla-300 drug-switching CGM studies, the mean nocturnal glucose level achieved by individuals during the Gla300 treatment phase was equivalent to that achieved during the Gla-100 therapy phase. e variability in mean nocturnal glucose levels (i.e., standard deviation (SD) and coefficient of variance (CV) values of mean nocturnal glucose levels) and mean amplitude of glucose excursions experienced by individuals between-nights was lower during the Gla-300 treatment period than the Gla-100 treatment period, albeit no significant differences in these metrics of glycemic variability between the two treatments were reached
Summary
Insulin therapy is recommended by clinical guidelines as the primary strategy for the management of type 1 diabetes (T1DM) and as the second-line therapy for type 2 diabetes (T2DM) [1,2,3]. While a number of advances have been made to improve glycemic control with longacting insulin products, hypoglycemia, in particular, nocturnal hypoglycemia and its associated adverse health consequences, remains a constant concern for clinicians when prescribing and managing patients with basal insulins [4,5,6]. Gla-300 is a new long-acting insulin product delivering the same unit amount of insulin glargine in one-third of the volume compared to Gla-100 and provides even greater glycemic control and hypoglycemia-reducing effects than Gla-100 through better mimicry of the physiological profile of endogenous basal insulin secretion during periods of fasting, between meals, and sleep [7,8,9]. In a series of 6 noninferiority phase 3 trials, the EDITION trials, the clinical benefits associated with the improved PK/PD profiles of Gla-300 over Gla-100 in hemoglobin A1c (HbA1c), and fasting plasma glucose management have been demonstrated in several cohorts of Advances in Medicine. Gla300 demonstrated comparable glycemic control as Gla-100 while significantly reducing the occurrence of nocturnal hypoglycemia events [14,15,16,17,18,19]
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