Switching to insulin glargine 300 units/mL in real‐world older patients with type 2 diabetes (DELIVER 3)

Abstract

Aim To compare the second‐generation basal insulin glargine 300 units/mL (Gla‐300) and first‐generation basal insulins on glycaemic control and hypoglycaemia risk in older adults with type 2 diabetes (T2D). Materials and methods DELIVER 3 was a retrospective observational cohort study of electronic medical records. A total of 1176 older adults (aged ≥ 65 years) with T2D and ≥1 HbA1c value during 6 month baseline and 3 to 6 month follow‐up who switched from basal insulin to Gla‐300 were propensity score‐matched to 1176 older adults who switched to a first‐generation basal insulin [insulin detemir (IDet) or insulin glargine 100 units/mL (Gla‐100)]. Outcomes were follow‐up HbA1c, achievement of HbA1c <7% and <8%, hypoglycaemia incidence and event rates, and healthcare resource utilization. Results Following basal insulin switching, HbA1c reductions were greater/similar with Gla‐300 versus IDet/Gla‐100 (variable follow‐up: −0.45% ± 1.40% vs. −0.29% ± 1.57%; P = .021; fixed follow‐up: −0.48% ± 1.49% vs. −0.38% ± 1.59%; P = .114), while HbA1c goal attainment was similar in both cohorts. Gla‐300 was associated with less hypoglycaemia [event rate: adjusted rate ratio (aRR): 0.63, 95% CI: 0.53‐0.75; P < .001] and inpatient/emergency department‐associated hypoglycaemia (adjusted hazard ratio: 0.58, 95% CI: 0.37‐0.90; P = .016; aRR: 0.43, 95% CI: 0.31‐0.60; P < .001) by variable follow‐up. By fixed follow‐up, hypoglycaemia results significantly or numerically favoured Gla‐300. Conclusion Among older adults with T2D, switching to Gla‐300 versus Gla‐100/IDet was associated with greater/similar improvements in glycaemic control, and generally less hypoglycaemia.

The Safety and Efficacy of Second-Generation Basal Insulin Analogues in Adults with Type 2 Diabetes at Risk of Hypoglycemia and Use in Other Special Populations: A Narrative Review

“…Retrospective RWE corroborates a comparable glycemic control and reduced hypoglycemia with second-generation compared with firstgeneration BI analogues [42][43][44][45][46], with potential cost offsets from a reduction in healthcare utilization and hospitalizations [44]. These findings have been observed in both insulin-naïve T2DM populations [45,46] and in participants who switched from another BI analogue [42][43][44].…”

“…Results for RWE studies also support the efficacy and safety of second-generation BIs in individuals with T2DM and obesity [42,43,51,52]. For example, in the DELIVER 3 [42], DELIVER Naïve [46], DELIVER Naïve D [45], DELIVER D?, [51] CONFIRM [52] and LIGHTNING [43] studies, the mean baseline BMI of patients was approximately 33-35 kg/ m 2 . Similarly, most patients in the SWITCH 2 double-blind, cross-over study with IDeg versus Gla-100 had obesity, with an mean BMI of 32.2 kg/m 2 .…”

“…Several RCTs and real-world analyses [11,42,43,48,71] have specifically aimed to include participants at a higher risk of hypoglycemia, such as those with a history of hypoglycemia or severe hypoglycemia. However, none of these investigations have provided further analyses to determine whether or not hypoglycemia benefits were realized in those with a documented history of hypoglycemia.…”

Suitable Use of Injectable Agents to Overcome Hypoglycemia Risk, Barriers, and Clinical Inertia in Community-Dwelling Older Adults with Type 2 Diabetes Mellitus

“…After 6 months' follow-up, patients treated with Gla-300 had significantly greater reductions in A1C (− 0.52 vs − 1.30; p = 0.003), with more Gla-300-treated patients achieving A1C < 7.0% (21.9% vs 17.4%; p = 0.003) without hypoglycemia [53]. In DELIVER 3, which studied older patients (≥ 65 years) with T2D switching to Gla-300 from first-generation basal insulins (Gla-100 or insulin detemir), A1C reductions were greater/similar with Gla-300, and A1C goal achievement was similar in both cohorts, but Gla-300-treated patients generally had less hypoglycemia (event rate: adjusted rate ratio 0.63, 95% CI 0.53-0.75; p < 0.001) [54]. Post-hoc and real-world analyses offer important insight, especially when addressing the outcomes in the subpopulation of older adults [52].…”

Clinical Outcomes of Switching to Insulin Glargine 300 U/ml from Other Basal Insulins in People with Type 2 Diabetes in Italy: A Real-World Study

“…Data obtained in the DELIVER program [19,21,22,[25][26][27] with comparative data in propensity-matched cohorts show that people with T2DM who switched to Gla-300 from other basal insulin analog regimens improved their glycemic control with fewer hypoglycemia events, confirming and complementing the results of the EDITION registration clinical program [7][8][9]. Particularly, the DELIVER 2 and 3 study showed that switching basal insulins in T2DM people with elevated HbA1c levels to Gla-300 was associated with significantly lower risk of hypoglycemia than switching to other basal insulins (mainly first-generation basal insulin), with comparable glycemic control; the lower risk of hypoglycemia-related, diabetes-related, and all-cause emergency room services translates into lower costs in patients using Gla-300 [22,24].…”