Effect of insulin degludec versus insulin glargine U100 on time in range: SWITCH PRO, a crossover study of basal insulin‐treated adults with type 2 diabetes and risk factors for hypoglycaemia. Issue 11 (16th August 2021)

• Record Type: Journal Article
• Authors: Goldenberg, Ronald M.; Aroda, Vanita R.; Billings, Liana K.; Christiansen, A. Sia Louise; Meller Donatsky, Anders; Parvaresh Rizi, Ehsan; Podgorski, Gracjan; Raslova, Katarina; Klonoff, David C.; Bergenstal, Richard M.
• Is Part Of: Diabetes, obesity & metabolism. Volume 23:Issue 11(2021)
• Page Start: 2572
• Page End: 2581
• Publication Date: 2021-08-16
• Subjects: basal insulins -- insulin analogues -- insulin treatment -- long‐acting basal insulin -- professional CGM -- type 2; Diabetes -- Periodicals; Obesity -- Periodicals; Metabolism -- Disorders -- Periodicals; Clinical pharmacology -- Periodicals; 616.462
• DOI: 10.1111/dom.14504
• Languages: English
• ISSNs: 1462-8902

Abstract

Abstract: Aims: To compare time in range (TIR) with use of insulin degludec U100 (degludec) versus insulin glargine U100 (glargine U100) in people with type 2 diabetes. Materials and Methods: We conducted a randomized, crossover, multicentre trial comparing degludec and glargine U100 in basal insulin‐treated adults with type 2 diabetes and ≥1 hypoglycaemia risk factor. There were two treatment periods, each with 16‐week titration and 2‐week maintenance phases (with evaluation of glucose using blinded professional continuous glucose monitoring). The once‐weekly titration (target: 3.9–5.0 mmol/L) was based on pre‐breakfast self‐measured blood glucose. The primary endpoint was percentage of TIR (3.9─10.0 mmol/L). Secondary endpoints included overall and nocturnal percentage of time in tight glycaemic range (3.9–7.8 mmol/L), and mean glycated haemoglobin (HbA1c) and glucose levels. Results: At baseline, participants (n = 498) had a mean (SD) age of 62.8 (9.8) years, a diabetes duration of 15.1 (7.7) years and an HbA1c level of 59.6 (11.0) mmol/mol (7.6 [1.0]%). Noninferiority and superiority were confirmed for degludec versus glargine U100 for the primary endpoint, with a mean TIR of 72.1% for degludec versus 70.7% for glargine U100 (estimated treatment difference [ETD] 1.43% [95% confidence interval (CI): 0.12, 2.74; P = 0.03] or 20.6 min/d). Overall time in tight glycaemic range favoured degludec versus glargine U100 (ETD 1.5% [95% CI: 0.15, 2.89] or 21.9 min/d). Degludec also reduced nocturnal time below range (TBR; <3.9 mmol/L) compared with glargine U100 (ETD −0.88% [95% CI: −1.34, −0.42] or 12.7 min/night; post hoc ) and significantly fewer nocturnal hypoglycaemic episodes of <3.0 mmol/L were observed. Conclusions: Degludec, compared with glargine U100, provided more TIR and time in tight glycaemic range, and reduced nocturnal TBR in insulin‐treated people with type 2 diabetes.