A comparison of the clinical courses of type 2 diabetic patients whose basal insulin preparation was replaced from insulin glargine 100 units/mL to insulin glargine biosimilar or 300 units/mL: a propensity score-matched observation study

Abstract

Objective: We compared the clinical course of type 2 diabetic patients whose basal insulin preparations were replaced from insulin glargine (IGlar) 100 units/mL (U100) to IGlar biosimilar or IGlar 300 units/mL (U300).Methods: After propensity score matching, 34 patients whose basal insulin preparation was switched from IGlar U100 to IGlar biosimilar and 102 switched to IGlar U300 were observed for 6 months.Results: The HbA1c level and body weight did not change significantly after the replacement in the IGlar biosimilar or IGlar U300 groups. In the IGlar biosimilar group, the frequency of subjects who experienced hypoglycemia after the replacement (12%) was not different from before (12%). However, the frequency was significantly lower after the replacement (2%) than before (13%) in the IGlar U300 group. The change in the HbA1c level after the replacement showed a significant association with the HbA1c level at the baseline but not with the kind of IGlar. Hypoglycemia was frequently observed in subjects who had experienced hypoglycemia before the replacement.Conclusions: IGlar biosimilar and IGlar U300 induced similar HbA1c and body weight changes among type 2 diabetic patients. IGlar biosimilar is a suitable option for patients with a low risk for hypoglycemia.

Reduced Hypoglycemia Risk in Type 2 Diabetes Patients Switched to/Initiating Insulin Glargine 300 vs 100 U/ml: A European Real-World Study

“…However, after controlling for covariates, the reduction in hypoglycemia events with Gla-300 remained significant. Here, once again, our data are in line with other real-world studies, which have shown reduced hypoglycemia risk with Gla-300 vs. (mainly) first-generation BIAs [ 18 , 21 – 23 , 33 ]. In the above-mentioned pragmatic studies that were mainly conducted in Europe, most hypoglycemia end points were similar for Gla-300 and standard-of-care BIA, but there were some significant reductions in nocturnal hypoglycemia with Gla-300 [ 26 ].…”

Potential cost-savings from the use of the biosimilars filgrastim, infliximab and insulin glargine in Canada: a retrospective analysis

“…Apprehension with biosimilar use generally pertains more to switching therapies for stable patients as opposed to initiation in treatment-naïve patients [13]; however, several studies have found that switching between agents does not confer any additional risk or lead to poorer clinical outcomes [13–15]. Although the safety and efficacy profile of biosimilar drugs cannot be assured to be 100% due to their complexity, existing data reassure that is very likely that biosimilar and originator biologics are relatively equal as it pertains to both [16–19].…”

New Insulins, Biosimilars, and Insulin Therapy

“…It has to be mentioned that Basalin was not approved as a BioIns in any of the regulated markets. In a similarly designed Japanese study with Abasaglar, no differences in HbA1c values between patients treated with the originator insulin glargine and the BioIns were observed; however, fasting glycemic values were not reported (15). Also, there are good reasons why the regulatory authorities in the United States and the EU require more precise measures than HbA1c results from clinical trials to approve an insulin as a BioIns.…”