Insulin glargine 300 units/mL for the treatment of individuals with type 2 diabetes in the real world: A review of the DELIVER programme

Abstract

Evidence from randomized controlled trials (RCTs) has shown that second-generation basal insulin (BI) analogues, insulin glargine 300 U/mL (Gla-300) and insulin degludec (IDeg), provide similar glycaemic control, with a lower risk of hypoglycaemia compared with the first-generation BI analogue insulin glargine 100 U/mL (Gla-100) in people with type 2 diabetes (T2D). However, the highly selected participants and frequent follow-up of RCTs may not be truly representative of real-life clinical practice.It is important to assess the safety and effectiveness of these second-generation BI analogues in real-life clinical practice settings. The DELIVER programme utilized electronic healthcare records from the United States to compare clinical outcomes in people with T2D who received either Gla-300 or other BI analogues in real-world clinical practice. This review provides a concise overview of the results of the DELIVER studies. Overall, Gla-300 provided similar antihyperglycaemic effectiveness and a lower risk of hypoglycaemia versus the first-generation BI analogues Gla-100 and insulin detemir in people with T2D who had switched BIs. In those who were insulin-naïve, initiation with Gla-300 versus Gla-100 was associated with significantly better antihyperglycaemic effectiveness and similar or lower hypoglycaemic risk.Both glycaemic control and hypoglycaemia risk were also shown to be similar with Gla-300 and IDeg, in people who had switched BIs and in those who were insulinnaïve. In addition, the DELIVER 2 study reported that people with T2D who switched to Gla-300 had reduced healthcare resource utilization, with an overall saving of US $1439 per person per year compared with those who switched to another BI analogue. Overall, the real-world DELIVER programme showed that the glycaemic control with a low risk of hypoglycaemia observed with Gla-300 in RCTs was also seen in standard clinical practice.

iGlarLixi versus basal plus Rapid‐Acting insulin in adults with type 2 diabetes advancing from basal insulin therapy: The SoliSimplify Real‐World study

“…26 In the eight studies comprising the DELIVER programme, which also utilized EMR data from the United States and PSM, between 15% and 27% of the participants treated with BI achieved HbA1c <7%. 27 As previously mentioned, there was a modest benefit for iGlarLixi versus BI + RAI for body weight change (<1 kg), with no weight gain seen in the iGlarLixi arm. Similarly, IDegLira (the other FRC of BI and GLP-1 RA) was associated with a small (<1 kg) but statistically significant benefit for body weight change compared with basal-bolus insulin, with no weight gain seen with IDegLira.…”

“… 26 In the eight studies comprising the DELIVER programme, which also utilized EMR data from the United States and PSM, between 15% and 27% of the participants treated with BI achieved HbA1c <7%. 27 …”

“…EMR data from more than 40 000 individuals across six countries showed that only ±28.7% reached HbA1c levels of <7% (<53 mmol/mol) 2 years after initiating BI therapy 26 . In the eight studies comprising the DELIVER programme, which also utilized EMR data from the United States and PSM, between 15% and 27% of the participants treated with BI achieved HbA1c <7% 27 …”

Comparative effectiveness of Glargine 300 U/mL vs. Degludec 100 U/mL in patients with type 2 diabetes switching from 1° generation basal insulins

“…The DELIVER program [11] was a series of RWE studies assessing clinical outcomes using electronic medical records (EMRs) of US people with T2D (insulin-naïve or switchers) treated with Gla-300 or other BI analogues. Overall, the DELIVER program showed that benefits of Gla-300 observed in RCTs were confirmed in standard clinical practice [11e13].…”

Therapie des Typ-2-Diabetes

“…Im DELIVER-PROGRAMM wurden die elektronischen Gesundheitsdaten (Real-World-Daten) von Menschen mit Typ-2-Diabetes, die Insulin glargin 300 erhielten, verglichen mit denen, die mit Insulin glargin 100, Insulin detemir oder Insulin degludec behandelt wurden [283]. Gla-300 zeigte wie Insulin degludec eine bessere blutglukosesenkende Effektitivität im Vergleich zu Gla-100 oder Insulin detemir und signifikant niedrigere Hypoglykämieraten.…”