Clinical outcomes in real-world patients with type 2 diabetes switching from first- to second-generation basal insulin analogues: Comparative effectiveness of insulin glargine 300 units/mL and insulin degludec in the DELIVER D+ cohort study

Abstract

Aims: To compare clinical outcomes in patients with type 2 diabetes (T2D) switching from insulin glargine 100 units/mL (Gla-100) or insulin detemir (IDet) to insulin glargine 300 units/mL (Gla-300) or insulin degludec (IDeg).

Materials and methods: We conducted a retrospective, observational study of electronic medical records for Gla-300/IDeg adult switchers (March 1, 2015 to January 31, 2017) with active records for 12-month baseline (glycated haemoglobin [HbA1c] used a 6-month baseline period) and 6-month follow-up periods. Gla-300 and IDeg switchers were propensity score-matched using baseline demographic and clinical characteristics. Outcomes were HbA1c change and goal attainment (among patients with HbA1c captured at follow-up), and hypoglycaemia with fixed follow-up (intention-to-treat [ITT]; 6 months) and variable follow-up (on-treatment [OT]; to discontinuation or 6 months).

Results: Each matched cohort comprised 1592 patients. The mean decrease in HbA1c and HbA1c goal (<7.0% [53 mmol/mol] and <8.0% [64 mmol/mol]) attainment rates were similar for Gla-300 (n = 742) and IDeg (n = 727) switchers. Using fixed follow-up (ITT method), hypoglycaemia incidence decreased significantly from baseline with Gla-300 (all hypoglycaemia: 15.6% to 12.7%; P = .006; hypoglycaemia associated with inpatient/emergency department [ED] encounter: 5.3% to 3.5%; P = .007), but not with IDeg. After adjusting for baseline hypoglycaemia, no significant differences in hypoglycaemia incidence and event rate were found at follow-up (ITT) for Gla-300 vs IDeg. Using variable follow-up (OT), hypoglycaemia incidence was similar in both groups, but Gla-300 switchers had a lower inpatient/ED hypoglycaemia event rate at follow-up (adjusted rate ratio 0.56; P = .016).

Conclusions: In a real-world setting, switching from Gla-100 or IDet to Gla-300 or IDeg was associated with similar improvements in glycaemic control and hypoglycaemia in adult patients with T2D.

Keywords: 2 diabetes; basal insulin; glycaemic control; hypoglycaemia; observational study; type.

Figure 1

Patient flow chart. EMR, electronic medical records; Gla‐100, insulin glargine 100 units/mL; Gla‐300, insulin glargine 300 units/mL; HbA1c, haemoglobin A1c; IDeg, insulin degludec; IDet, insulin detemir; T1D, type 1 diabetes; T2D, type 2 diabetes. ^†See Table S1 for the conditions used to identify patients with T1D

Figure 2

Glycated haemoglobin (HbA1c) outcomes among matched patients with HbA1c test results during baseline (0‐6 months prior to the index date) and follow‐up (3‐6 months after the index date): (A) mean ± SD values during baseline and follow‐up; (B) attainment of goals (<7.0% [53 mmol/mol] and <8.0% [64 mmol/mol]). Gla‐300, insulin glargine 300 units/mL; IDeg, insulin degludec

Figure 3

Hypoglycaemia outcomes among all matched patients during fixed 6‐month follow‐up: (A) incidence; (B) adjusted event rate; (C) inpatient/ emergency department (ED) hypoglycaemia incidence; (D) inpatient/ED hypoglycaemia adjusted event rate; (E) hypoglycaemia incidence decreases from baseline to follow‐up. aOR, odds ratio adjusted for baseline hypoglycaemia incidence; CI, confidence interval; Gla‐300, insulin glargine 300 units/mL; IDeg, insulin degludec; LSM, least squares mean; PPPY, per person per year. ^† P values adjusted for baseline hypoglycaemia incidence