Glycaemic goal attainment and hypoglycaemia outcomes in type 2 diabetes patients initiating insulin glargine 300 units/mL or 100 units/mL: Real‐world results from the DELIVER Naïve cohort study

Abstract

Aims To compare HbA1c and hypoglycaemia in insulin‐naïve patients with type 2 diabetes (T2D) who initiated insulin glargine 300 units/mL (Gla‐300) or 100 units/mL (Gla‐100). Materials and methods This retrospective cohort study examined electronic medical records of insulin‐naïve adults with T2D who initiated Gla‐300 or Gla‐100 during March 2015 through to December 2016 with active records for ≥12 months before and ≥6 months after initiation, and ≥1 valid HbA1c value during 6‐month baseline and 90–180‐day follow‐up. Outcomes included HbA1c and hypoglycaemia. Cohorts were propensity score‐matched (1:2) on baseline demographic and clinical characteristics. Sensitivity analyses were conducted using broader inclusion criteria. Results The matched cohorts included 1004 Gla‐300 and 2008 Gla‐100 initiators (mean age 60.4 years; 53.2% male). During 6‐month follow‐up, Gla‐300 versus Gla‐100 initiators had a greater mean HbA1c decrease (−1.52 ± 2.08% vs. –1.30 ± 2.12%; P = 0.003) and more patients achieved HbA1c <7% (25.0% vs. 21.5%; P = 0.029) and <8% (55.0% vs. 49.2%; P = 0.002); and HbA1c <7% (21.9% vs. 17.4%; P = 0.003) and <8% (49.1% vs. 41.8%; P < 0.001) without hypoglycaemia. Gla‐300 initiators were similarly or less likely to have any or inpatient/emergency department‐associated hypoglycaemia during 3‐ and 6‐month follow‐up (e.g. any hypoglycaemia to 6 months: 9.7% vs. 12.5%; adjusted odds ratio 0.61; P = 0.057). Conclusions Among insulin‐naïve adults with T2D, Gla‐300 was associated with significantly better HbA1c reductions (latest value during 90–180‐day follow‐up) and similar or improved hypoglycaemia outcomes (3‐ and 6‐month follow‐up) than Gla‐100.

Effectiveness and safety of insulin glargine 300 U/mL in insulin‐naïve patients with type 2 diabetes after failure of oral therapy in a real‐world setting

“…This led to comparable mean reductions in HbA1c (−1.22% vs. –1.29%) observed 12 months after starting Gla‐300 treatment in our study and in EDITION 3 . In two recently published observational studies evaluating electronic medical records, insulin‐naïve type 2 diabetes patients in the United States were reported to reduce HbA1c levels by −1.67% and −1.52%, respectively, during 3 to 6 months follow‐up; however, both studies started from higher baseline HbA1c values of 9.7% and 9.6%, respectively …”

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 .…”

Comparable glycaemic control and hypoglycaemia in adults with type 2 diabetes after initiating insulin glargine 300 units/mL or insulin degludec: The DELIVER Naïve D real‐world study

“…6 The DELIVER Naive real-world observational study, which used electronic medical record (EMR) data, showed improved HbA1c control and suggested reduced hypoglycaemia with Gla-300 versus Gla-100 in insulin-naïve adults with T2D. 7 Two other real-world, observational studies (DELIVER D 8 and DELIVER D+ 9 ) compared Gla-300 and IDeg in patients with T2D who switched from first-generation basal insulin analogues. Both studies found that Gla-300 and IDeg resulted in comparable reductions in HbA1c and similar levels of hypoglycaemia.…”