Comparison of treatment with insulin degludec and glargine U100 in patients with type 1 diabetes prone to nocturnal severe hypoglycaemia: The HypoDeg randomized, controlled, open‐label, crossover trial

• Published in: Diabetes, obesity & metabolism Vol. 24; no. 2; pp. 257 - 267
• Main Authors: Pedersen‐Bjergaard, Ulrik, Agesen, Rikke M., Brøsen, Julie M. B., Alibegovic, Amra C., Andersen, Henrik U., Beck‐Nielsen, Henning, Gustenhoff, Peter, Hansen, Troels K., Hedetoft, Christoffer, Jensen, Tonny J., Juhl, Claus B., Jensen, Andreas K., Lerche, Susanne S., Nørgaard, Kirsten, Parving, Hans‐Henrik, Sørensen, Anne L., Tarnow, Lise, Thorsteinsson, Birger
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.02.2022; Wiley Subscription Services, Inc
• Subjects: Adult; basal insulin; Blood Glucose - analysis; Cross-Over Studies; Diabetes; Diabetes mellitus (insulin dependent); Diabetes Mellitus, Type 1 - complications; Diabetes Mellitus, Type 1 - drug therapy; Glycated Hemoglobin A - analysis; Humans; hypoglycaemia; Hypoglycemia; Hypoglycemia - chemically induced; Hypoglycemia - epidemiology; Hypoglycemia - prevention & control; Hypoglycemic Agents - adverse effects; Insulin; insulin analogues; Insulin Glargine - adverse effects; Insulin, Long-Acting; Original; Patients; phase IV study; Prospective Studies; randomized trial; type 1 diabetes; phase IV study; basal insulin; type 1 diabetes; insulin analogues; hypoglycaemia; randomized trial
• ISSN: 1462-8902; 1463-1326
• DOI: 10.1111/dom.14574

Aim To investigate whether the long‐acting insulin analogue insulin degludec compared with insulin glargine U100 reduces the risk of nocturnal symptomatic hypoglycaemia in patients with type 1 diabetes (T1D). Methods Adults with T1D and at least one episode of nocturnal severe hypoglycaemia during the last 2 years were included in a 2‐year prospective, randomized, open, multicentre, crossover trial. A total of 149 patients were randomized 1:1 to basal‐bolus therapy with insulin degludec and insulin aspart or insulin glargine U100 and insulin aspart. Each treatment period lasted 1 year and consisted of 3 months of run‐in or crossover followed by 9 months of maintenance. The primary endpoint was the number of blindly adjudicated nocturnal symptomatic hypoglycaemic episodes. Secondary endpoints included the occurrence of severe hypoglycaemia. We analysed all endpoints by intention‐to‐treat. Results Treatment with insulin degludec resulted in a 28% (95% CI: 9%‐43%; P = .02) relative rate reduction (RRR) of nocturnal symptomatic hypoglycaemia at level 1 (≤3.9 mmol/L), a 37% (95% CI: 16%‐53%; P = .002) RRR at level 2 (≤3.0 mmol/L), and a 35% (95% CI: 1%‐58%; P = .04) RRR in all‐day severe hypoglycaemia compared with insulin glargine U100. Conclusions Patients with T1D prone to nocturnal severe hypoglycaemia have lower rates of nocturnal symptomatic hypoglycaemia and all‐day severe hypoglycaemia with insulin degludec compared with insulin glargine U100.