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Randomized Controlled Trial
. 2023 Jun;25(6):1557-1565.
doi: 10.1111/dom.15003. Epub 2023 Feb 28.

Effect of insulin degludec versus insulin glargine U100 on nocturnal glycaemia assessed by plasma glucose profiles in people with type 1 diabetes prone to nocturnal severe hypoglycaemia

Julie Maria Bøggild Brøsen  1   2 , Rikke Mette Agesen  1   2 , Peter Lommer Kristensen  1   2 , Amra Ciric Alibegovic  3 , Henrik Ullits Andersen  2   3 , Henning Beck-Nielsen  4   5 , Peter Gustenhoff  6 , Troels Krarup Hansen  7   8 , Christoffer Hedetoft  9 , Tonny Jensen  10 , Charlotte Røn Stolberg  4   5   11 , Claus Bogh Juhl  5   11   12 , Susanne Søgaard Lerche  13 , Kirsten Nørgaard  2   3   14 , Hans-Henrik Parving  2   10 , Lise Tarnow  15   16 , Birger Thorsteinsson  1   2 , Ulrik Pedersen-Bjergaard  1   2
Affiliations
Randomized Controlled Trial

Effect of insulin degludec versus insulin glargine U100 on nocturnal glycaemia assessed by plasma glucose profiles in people with type 1 diabetes prone to nocturnal severe hypoglycaemia

Julie Maria Bøggild Brøsen et al. Diabetes Obes Metab. 2023 Jun.

Abstract

Aim: To compare nocturnal glucose profiles according to hourly plasma glucose measurements during treatment with insulin degludec and insulin glargine U100 in a cohort of people with type 1 diabetes prone to nocturnal severe hypoglycaemia.

Materials and methods: The HypoDeg trial is a 2-year investigator-initiated, randomized, controlled crossover trial in 149 participants randomized to treatment with insulin degludec and insulin glargine U100 for 12 months each. The 51 participants in this predefined substudy stayed at least one night in hospital during each treatment arm for plasma glucose samples to be taken. Endpoints were glucose profiles, including mean plasma glucose, glycaemic variability and risk of hypoglycaemia.

Results: There were no differences between treatments regarding mean plasma glucose. We saw a flatter glucose profile during insulin degludec compared with insulin glargine U100 treatment, which had a nadir at 4:00 AM, with a subsequent rise. During treatment with insulin degludec, the participants had lower glycaemic variability, with an estimated treatment difference of -4.3% (95% confidence interval [CI] -8.1 to -0.5; P < 0.05). Participants treated with insulin degludec were less likely to experience nocturnal hypoglycaemia below 3.0 mmol/L (hazard ratio 0.36 [95% CI 0.17-0.73; P < 0.05]).

Conclusion: Based on nocturnal plasma glucose measurements, treatment with insulin degludec compared with insulin glargine U100 administered in the evening results in lower glycaemic variability and lower risk of nocturnal hypoglycaemia without differences in mean plasma glucose.

Keywords: basal insulin; clinical trial; glycaemic control; hypoglycaemia; insulin analogues; type 1 diabetes.

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References

REFERENCES

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