A comparative effectiveness study of degludec and insulin glargine 300 U/mL in insulin‐naïve patients with type 2 diabetes

Abstract

Aims To compare the real‐world effectiveness of insulin degludec (degludec) and glargine 300 units/mL (glargine U300) in insulin‐naïve adult patients with type 2 diabetes in routine US clinical practice. Materials and methods CONFIRM is a non‐interventional comparative effectiveness study following US patients across the continuum of care, through electronic medical records from multiple health systems and integrated delivery networks. Propensity‐score matching controlled for confounding. The primary endpoint, change in HbA1c from baseline to 180 days of follow‐up, was estimated using a repeated‐measure of covariance analysis with subject as random effect. Change in the rate of hypoglycaemic episodes (defined using International Classification of Diseases codes 9/10) and change in proportion of patients with hypoglycaemia were estimated using negative binomial and logistic regression, respectively. Time‐to‐discontinuation of the initial basal insulin/initiation with another prescribed basal insulin was analysed using a Cox Proportional Hazard model. Results Data concerning 4056 patients were analysed. After matching, baseline characteristics were comparable (n = 2028 in each group). After 180 days of follow‐up, degludec was associated with a larger reduction in HbA1c (estimated treatment difference, −0.27%; P = 0.03), greater reductions in change in rate (rate ratio, 0.70; P < 0.05) and greater reductions in change in the likelihood of hypoglycaemia (odds ratio, 0.64; P < 0.01]) compared with glargine U300. In addition, patients treated with degludec were 27% less likely to discontinue treatment at follow‐up compared with those treated with glargine U300 (hazard ratio, 0.73; P < 0.001). Conclusions Significantly improved HbA1c, larger reductions in rates and likelihood of hypoglycaemia and lower risk of treatment discontinuation were demonstrated with degludec vs glargine U300.

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

“…Although the results from the current study are consistent with data from the BRIGHT trial in insulin‐naïve adults with T2D and the three previous real‐world studies in insulin‐naïve or ‐experienced adults with T2D, there are some interesting differences between the insulin‐naïve studies. Firstly, patients in the current study had considerably higher mean baseline HbA1c values than those in the BRIGHT trial [9.7% vs. 8.6% (83 vs. 71 mmol/mol, respectively)].…”

“…The CONFIRM study examined the EMRs of insulin-naïve adults with T2D from the same database as the current study (Explorys; IBM Watson Health), but reported that IDeg was associated with a significantly larger mean HbA1c reduction and significantly greater "reductions in the change in the likelihood of hypoglycaemia" than Gla-300. 17 The CONFIRM findings, however, appear to be the consequence of methodological dif- there may also be baseline imbalances here too, perhaps providing an explanation for the CONFIRM study's deviation from the current evidence base. Finally, it is worth noting that the CONFIRM population appears to have a pattern of baseline medication that is inconsistent with what might be expected for an insulin-naïve cohort.…”

Comment on “a comparative effectiveness study of degludec and insulin glargine 300 U/mL in insulin‐naïve patients with type 2 diabetes”

“…Tibaldi et al report results of the propensity‐matched observational CONFIRM study in previously insulin‐naïve adults with type 2 diabetes, comparing two second‐generation basal insulins. Using patients' electronic medical records from a large US database, they report an association between treatment with insulin degludec (IDeg) and a reduction in glycated haemoglobin (HbA1c) and hypoglycaemia rates, compared with insulin glargine 300 units/mL (Gla‐300).…”

The importance of the initial period of basal insulin titration in people with diabetes

“…No significant between‐treatment differences in hypoglycaemia incidence or rates (hospitalizations or ED visits) were observed between Gla‐300 or IDeg following adjustment for baseline hypoglycaemia . By contrast, CONFIRM showed significantly greater HbA1c reductions with IDeg than Gla‐300 (−1.48% vs. −1.22%; P = 0.03) . Similarly, over the initial 180 days, the proportion of patients experiencing ≥1 hypoglycaemic event was significantly lower with IDeg than Gla‐300 ( P <0.01) and fewer patients discontinued treatment with IDeg than Gla‐300 (13% vs. 21%; P <0.001) …”

“…Real‐world studies comparing first‐ and second‐generation BIs using electronic health record data have also been conducted. The CONFIRM and DELIVER‐D+ studies compared HbA1c reduction and hypoglycaemia risk in US patient records for individuals using either Gla‐300 or IDeg, with both studies using propensity score matching (PSM) to account for potential confounders; however, these studies showed conflicting results . DELIVER‐D+ showed similar HbA1c reductions (Gla‐300: 0.63 [SD 1.7]%, IDeg‐100: 0.58 [1.6]%; P = 0.488) and HbA1c <7% target achievement (Gla‐300: 15.1%, IDeg: 16.1%; P = 0.628) from baseline to 3–6 months’ follow‐up .…”