A European, multicentre, retrospective, non‐interventional study (EU‐TREAT) of the effectiveness of insulin degludec after switching basal insulin in a population with type 1 or type 2 diabetes

Abstract

AimsTo evaluate the clinical effectiveness of switching to insulin degludec (IDeg) in insulin‐treated patients with either type 1 diabetes (T1DM) or type 2 diabetes (T2DM) under conditions of routine clinical care.Materials and MethodsThis was a multicentre, retrospective, chart review study. In all patients, basal insulin was switched to IDeg at least 6 months before the start of data collection. Baseline was defined as the most recent recording during the 3‐month period before first prescription of IDeg. Values are presented as mean [95%CI].ResultsT1DM (n = 1717): HbA1c decreased by −2.2 [−2.6; −2.0] mmol/mol (−0.20 [−0.24; −0.17]%) at 6 months vs baseline (P < .001). Rate ratio of overall (0.79 [0.69; 0.89]), non‐severe nocturnal (0.54 [0.42; 0.69]) and severe (0.15 [0.09; 0.24]) hypoglycaemia was significantly lower in the 6‐month post‐switch period vs the pre‐switch period (P < .001 for all). Total daily insulin dose decreased by −4.88 [−5.52; −4.24] U (−11%) at 6 months vs baseline (P < .001). T2DM (n = 833): HbA1c decreased by −5.6 [−6.3; −4.7] mmol/mol (−0.51 [−0.58; −0.43] %) at 6 months vs baseline (P < .001). Rate ratio of overall (0.39 [0.27; 0.58], P < .001), non‐severe nocturnal (0.10 [0.06; 0.16], P < .001) and severe (0.075 [0.01; 0.43], P = .004) hypoglycaemia was significantly lower in the 6‐month post‐switch period vs the pre‐switch period. Total daily insulin dose decreased by −2.48 [−4.24; −0.71] U (−3%) at 6 months vs baseline (P = .006). Clinical outcomes for T1DM and T2DM at 12 months were consistent with results at 6 months.ConclusionsThis study demonstrates that switching patients to IDeg from other basal insulins improves glycaemic control and significantly reduces the risk of hypoglycaemia in routine clinical practice.

Clinical benefits of switching to insulin degludec irrespective of previous basal insulin therapy in people with Type 1 or Type 2 diabetes: evidence from a European, multicentre, retrospective, non‐interventional study (EU‐TREAT)

“…† P <0.05. Data for the overall population were published in the primary manuscript ; all changes were from baseline. Glargine U100, insulin glargine 100 units/ mL ; ID et, insulin detemir; n , number of participants; NPH , neutral protamine Hagedorn.…”

“…Limitations of the present analysis include those of the study previously reported, such as its observational, retrospective design and the absence of a comparator arm [12]. In addition, participants in EU-TREAT were empirically (a) Type chosen, as people were switched to degludec because of difficulties while on their previous regimens, and demographic differences such as duration of diabetes and insulin treatment could potentially influence the risk of hypoglycaemia and response to the treatment change.…”

“…A larger population in each previous basal insulin group may be beneficial in order to provide sufficient data to calculate the missing rate ratios of hypoglycaemia in the present analysis. The strengths of EU-TREAT have been reported previously, including the large-scale, multicentre/country design, the use of real-world data, and all treatment decisions being made independently of the study [12]. Additional strengths of the present study include the consistency in direction and magnitude of the results at 6 and 12 months, and in two different diseases (Type 1 and Type 2 diabetes) and three previous basal insulin groups (glargine U100, IDet and NPH), which support the conclusion that the changes in clinical outcomes were robust observations.…”

“…*P<0.05. Data for the overall population were published in the primary manuscript [12]; all comparisons were based on similar 6-or 12-month time frames, i.e. 0 to +6 vs À6 to 0 months, or 0 to +12 vs À12 to 0 months post-and pre-switch, respectively.…”

Short‐term cost‐utility of degludec versus glargine U100 for patients with type 2 diabetes at high risk of hypoglycaemia and cardiovascular events: A Canadian setting (DEVOTE 9)

“…In an additional sensitivity analysis, long‐term costs and clinical outcomes with degludec vs glargine U100 were simulated over a 50‐year time horizon in the IQVIA CORE Diabetes Model version 9.0 (IQVIA, Basel, Switzerland) using cardiovascular risk equations from the United Kingdom Prospective Diabetes Study (UKPDS) Outcomes Model 2 and parameters detailed in Table S4 . Cost and effectiveness outcomes, the latter expressed in QALYs, were attached to each of the four scenarios detailed in Figure S2 and did not vary between treatment arms.…”