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

Ulrik Pedersen-Bjergaard*, Rikke M Agesen, Julie M B Brøsen, Amra C Alibegovic, Henrik U Andersen, Henning Beck-Nielsen, Peter Gustenhoff, Troels K Hansen, Christoffer Hedetoft, Tonny J Jensen, Claus B Juhl, Andreas K Jensen, Susanne S Lerche, Kirsten Nørgaard, Hans-Henrik Parving, Anne L Sørensen, Lise Tarnow, Birger Thorsteinsson

*Corresponding author af dette arbejde

Publikation: Bidrag til tidsskriftArtikelForskningpeer review

Abstrakt

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.

OriginalsprogEngelsk
Sider (fra-til)257-267
Antal sider11
TidsskriftDiabetes, Obesity and Metabolism
Vol/bind24
Udgave nummer2
DOI
StatusUdgivet - feb. 2022

Bibliografisk note

© 2021 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

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