Comparative Effectiveness of Switching From First-Generation Basal Insulin to Glargine 300 U/ml or Degludec 100 U/ml in Type 1 Diabetes: The RESTORE-1 Study

Abstract

Introduction Following pivotal trials, real-world evidence is important to assess the impact of new drugs in everyday clinical practice. The RESTORE-1 study aimed to compare effectiveness and safety of the second-generation basal insulins (2BI), i.e., insulin glargine 300 U/ml (Gla-300) vs. degludec 100 U/ml (IDeg-100), in type 1 diabetes (T1D). Methods Retrospective, non-inferiority, multicenter study, based on electronic medical records. All patients switching to Gla-300 or IDeg-100 from first-generation basal insulins (1BI) were 1:1 propensity score matched (PSM). Changes during 6 months in HbA1c (primary endpoint), fasting plasma glucose (FPG), body weight, and insulin doses were assessed using linear mixed models for repeated measures. Incidence rates (IR) of hypoglycemic events were assessed. Results Overall, 19 centers provided data on 585 patients in each PSM cohort. For both groups, statistically significant reductions in HbA1c from baseline to 6 months were documented: − 0.20%; (95% CI − 0.32; − 0.08) in the Gla-300 group and − 0.14%; (95% CI − 0.24; − 0.04) in the IDeg-100 group. The non-inferiority of Gla-300 vs. IDeg-100 was confirmed (non-inferiority margin of 0.30%; upper 95% CI at 6 months, 0.09%). No statistically significant between-group differences emerged in FPG and body weight. Dose changes of basal and short-acting insulin were small in both groups, but higher in the Gla-300 group than in the Deg-100 group ( p < 0.006). Incidence rates (IR) of hypoglycemia (blood glucose ≤ 70 mg/dl and < 54 mg/dl) during the 6-month follow-up by treatment were slightly lower in the Gla-300 group than in the Deg-100 group [IR ratios 0.82 (95% CI 0.55; 1.22) and 0.83; (95% CI 0.38; 1.83), respectively]. Hypoglycemic events (blood glucose < 54 mg/dl) decreased at 6 months in both groups ( p = 0.01 for Gla-300 and p < 0.001 for IDeg-100). There were no severe hypoglycemic events for Gla-300 and seven events for IDeg-100 ( p = 0.02). Conclusions Switching from 1BI to 2BI in adults with T1D was associated with similar improvements in glycemic control and overall significant decrease in hypoglycemia, with no severe events with Gla-300. Effectiveness of both insulins was limited by under-titration. Supplementary Information The online version contains supplementary material available at 10.1007/s13300-020-00982-z.

Comparative clinical outcomes of insulin degludec and insulin glargine 300 U/mL after switching from other basal insulins in real‐world patients with type 1 and type 2 diabetes

“…Another retrospective study 17 , similar to the present study, investigated the effects of IDeg and Gla300 after switching from NPH, IDet and Gla100 in patients with type 1 diabetes, and showed a smaller reduction of HbA1c (−0.14% and −0.20%, respectively) than that of our study. This discrepancy might be due to the lower mean HbA1c (7.9%) and larger percentage of Gla100 (95%) at baseline in the study than those of the present study.…”

Effectiveness and Safety of Insulin Glargine 300 U/ml in Comparison with Insulin Degludec 100 U/ml Evaluated with Continuous Glucose Monitoring in Adults with Type 1 Diabetes and Suboptimal Glycemic Control in Routine Clinical Practice: The OneCARE Study

“…Our real-world study suggests that both BIs are similar in achieving CGM targets according to international consensus, mainly 24-h TIR 70-180 mg/dl. The recent RESTORE real-world retrospective study has also shown that switching from a first-generation BI to Gla-300 or IDeg-100 provided similar improvements in glycemic control and a significant decrease in hypoglycemia [30].…”

Comparative effectiveness and safety of glargine 300 U/mL versus degludec 100 U/mL in insulin-naïve patients with type 2 diabetes. A multicenter retrospective real-world study (RESTORE-2 NAIVE STUDY)

“…A study on T1D (RESTORE-1) based on the same methodology described here has recently been published [ 27 ]. In agreement with RESTORE-1 findings, the take-home message from our new RESTORE-2 is the confirmation of a similar effectiveness and safety of the two 2BI.…”