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.

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.

• Authors: Ronald M Goldenberg, Vanita R Aroda, Liana K Billings, A Sia Louise Christiansen, Anders Meller Donatsky, Ehsan Parvaresh Rizi, Gracjan Podgorski, Katarina Raslova, David C Klonoff, Richard M Bergenstal
• Journal: Diabetes, obesity & metabolism (Diabetes Obes Metab) Vol. 23 Issue 11 Pg. 2572-2581 (11 2021) ISSN: 1463-1326 [Electronic] England
• PMID: 34322967 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2021 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

Chemical References

• Blood Glucose
• Glycated Hemoglobin A
• Hypoglycemic Agents
• Insulin, Long-Acting
• Insulin Glargine
• insulin degludec

Topics

• Adult
• Blood Glucose
• Blood Glucose Self-Monitoring
• Cross-Over Studies
• Diabetes Mellitus, Type 2 (drug therapy, epidemiology)
• Glycated Hemoglobin (analysis)
• Humans
• Hypoglycemia (chemically induced, epidemiology)
• Hypoglycemic Agents (adverse effects)
• Insulin Glargine (adverse effects)
• Insulin, Long-Acting
• Middle Aged
• Risk Factors