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.

The CONFIRM study compared the real-world effectiveness of degludec and glargine U300 in insulin-naïve patients with T2D. This retrospective, non-interventional comparative effectiveness study used electronic health records of U.S.-based patients from Explorys, with propensity-score matching to balance baseline characteristics between cohorts. The primary endpoint, ∆A1C from baseline to 6 months follow-up, was estimated using a repeated-measure analysis with subject as random effect. Rate of hypoglycemic episodes (defined using International Classification of Diseases codes 9/10) and proportion of patients with hypoglycemia were estimated using negative binomial and logistic regression, respectively. Time-to-discontinuation of basal insulin was analyzed using a Cox Proportional Hazard model. This study included adults with T2D treated with oral antidiabetic drugs, intensified with either degludec or glargine U300. Data from 4056 patients were analyzed. After matching, baseline characteristics of the groups were comparable (n=2028 in each group). At follow-up ∆A1C was significantly lower with degludec (─1.5%) vs. glargine U300 (─1.2% [treatment difference, ─0.3%, p=0.029]). Rates of hypoglycemia were significantly lower with degludec vs. glargine U300, (rate ratio: 0.70, p=0.045) similarly the proportion of patients experiencing hypoglycemia was significantly lower with degludec (odds ratio: 0.64; p&lt;0.01). Patients treated with glargine U300 had a 37% higher risk of treatment discontinuation vs. degludec (hazard ratio: 1.37, p&lt;0.01). Data from the largest real-world comparative effectiveness study of degludec and glargine U300 to date, demonstrated improved glycemic control, lower rates of hypoglycemia and risk of discontinuation with degludec vs. glargine U300. Disclosure J. Tibaldi: Speaker's Bureau; Self; AstraZeneca. Advisory Panel; Self; Intarcia Therapeutics, Inc.. Speaker's Bureau; Self; Merck & Co., Inc.. Consultant; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Novo Nordisk A/S. S. Haldrup: Employee; Self; Novo Nordisk A/S. V. Sandberg: Employee; Self; Novo Nordisk A/S. M.L. Wolden: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. Stock/Shareholder; Spouse/Partner; Novo Nordisk A/S. H.W. Rodbard: Advisory Panel; Self; AstraZeneca, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk A/S, Sanofi, Regeneron Pharmaceuticals, Inc.. Consultant; Self; AstraZeneca, Janssen Pharmaceuticals, Inc.. Advisory Panel; Self; Boehringer Ingelheim GmbH. Consultant; Self; Boehringer Ingelheim GmbH, Merck & Co., Inc., Novo Nordisk A/S, Sanofi, Regeneron Pharmaceuticals, Inc.. Consultant; Spouse/Partner; Informed Data Systems Inc., Novo Nordisk A/S, One Drop, Sanofi. Research Support; Self; AstraZeneca, Bristol-Myers Squibb Company, Boehringer Ingelheim GmbH, Janssen Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk A/S, Sanofi. Speaker's Bureau; Self; AstraZeneca, Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk A/S, Sanofi.