Clinical Outcome Assessment of the Effectiveness of Insulin Degludec (Degludec) in Real-life Medical Practice (CONFIRM)—A Comparative Effectiveness Study of Degludec and Insulin Glargine 300U/mL (Glargine U300) in Insulin-Naïve Patients with Type 2 Diabetes (T2D)
Authors: TIBALDI JOSEPH , HALDRUP STEFFEN , SANDBERG VIKTOR , WOLDEN MICHAEL L. , RODBARD HELENA W. 
Published: June 2018

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.