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; Rikke Mette Agesen; Peter Lommer Kristensen; Amra Ciric Alibegovic; Henrik Ullits Andersen; Henning Beck-Nielsen; Peter Gustenhoff; Troels Krarup Hansen; Christoffer Hedetoft; Tonny Jensen; Charlotte Røn Stolberg; Claus Bogh Juhl; Susanne Søgaard Lerche; Kirsten Nørgaard; Hans-Henrik Parving; Lise Tarnow; Birger Thorsteinsson; Ulrik Pedersen-Bjergaard

doi:10.1111/dom.15003

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, Rikke Mette Agesen, Peter Lommer Kristensen, Amra Ciric Alibegovic, Henrik Ullits Andersen, Henning Beck-Nielsen, Peter Gustenhoff, Troels Krarup Hansen, Christoffer Hedetoft, Tonny Jensen, Charlotte Røn Stolberg, Claus Bogh Juhl, Susanne Søgaard Lerche, Kirsten Nørgaard, Hans-Henrik Parving, Lise Tarnow, Birger Thorsteinsson, Ulrik Pedersen-Bjergaard

Institut for Klinisk Medicin - SDCA-Steno Diabetes Center Aarhus

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avis › Tidsskriftartikel › Forskning › peer review

Abstract

AIMS: Nocturnal glucose control in people with type 1 diabetes on multiple daily injection therapy is hampered by the risk of hypoglycaemia. Insulin degludec lowers the risk of patient-reported and continuous glucose monitoring-recorded nocturnal hypoglycaemia. In a cohort of people with type 1 diabetes prone to nocturnal severe hypoglycaemia, we compared nocturnal glucose profiles by hourly plasma glucose measurements during treatment with insulin degludec and insulin glargine U100.

MATERIALS AND METHODS: The HypoDeg trial is a 2-year investigator-initiated, randomised, controlled crossover trial in 149 participants randomised to treatment with insulin degludec and insulin glargine U100 for 12 months each. The 51 participants in this pre-defined sub-study stayed at least one night during each treatment arm in-hospital for plasma glucose samples. 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 to insulin glargine U100, which had a nadir at 04:00 with a subsequent rise. During treatment with insulin degludec, the participants had a lower glycaemic variability with an estimated treatment difference of -4.3% ([95% CI: -8.1 - -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 to insulin glargine U100 administered in the evening results in lower glycaemic variability and lower risk of nocturnal hypoglycaemia without differences in mean plasma glucose. This article is protected by copyright. All rights reserved.

Originalsprog	Engelsk
Tidsskrift	Diabetes, Obesity and Metabolism
Vol/bind	25
Nummer	6
Sider (fra-til)	1557-1565
Antal sider	9
ISSN	1462-8902
DOI	https://doi.org/10.1111/dom.15003
Status	Udgivet - jun. 2023

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Brøsen, J. M. B., Agesen, R. M., Kristensen, P. L., Alibegovic, A. C., Andersen, H. U., Beck-Nielsen, H., Gustenhoff, P., Hansen, T. K., Hedetoft, C., Jensen, T., Stolberg, C. R., Juhl, C. B., Lerche, S. S., Nørgaard, K., Parving, H.-H., Tarnow, L., Thorsteinsson, B., & Pedersen-Bjergaard, U. (2023). 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. Diabetes, Obesity and Metabolism, 25(6), 1557-1565. https://doi.org/10.1111/dom.15003

@article{b4c6e12a378545a990b6a8524e8d0df2,

title = "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",

abstract = "AIMS: Nocturnal glucose control in people with type 1 diabetes on multiple daily injection therapy is hampered by the risk of hypoglycaemia. Insulin degludec lowers the risk of patient-reported and continuous glucose monitoring-recorded nocturnal hypoglycaemia. In a cohort of people with type 1 diabetes prone to nocturnal severe hypoglycaemia, we compared nocturnal glucose profiles by hourly plasma glucose measurements during treatment with insulin degludec and insulin glargine U100.MATERIALS AND METHODS: The HypoDeg trial is a 2-year investigator-initiated, randomised, controlled crossover trial in 149 participants randomised to treatment with insulin degludec and insulin glargine U100 for 12 months each. The 51 participants in this pre-defined sub-study stayed at least one night during each treatment arm in-hospital for plasma glucose samples. 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 to insulin glargine U100, which had a nadir at 04:00 with a subsequent rise. During treatment with insulin degludec, the participants had a lower glycaemic variability with an estimated treatment difference of -4.3% ([95% CI: -8.1 - -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 to insulin glargine U100 administered in the evening results in lower glycaemic variability and lower risk of nocturnal hypoglycaemia without differences in mean plasma glucose. This article is protected by copyright. All rights reserved.",

keywords = "basal insulin, clinical trial, glycaemic control, hypoglycaemia, insulin analogues, type 1 diabetes",

author = "Br{\o}sen, {Julie Maria B{\o}ggild} and Agesen, {Rikke Mette} and Kristensen, {Peter Lommer} and Alibegovic, {Amra Ciric} and Andersen, {Henrik Ullits} and Henning Beck-Nielsen and Peter Gustenhoff and Hansen, {Troels Krarup} and Christoffer Hedetoft and Tonny Jensen and Stolberg, {Charlotte R{\o}n} and Juhl, {Claus Bogh} and Lerche, {Susanne S{\o}gaard} and Kirsten N{\o}rgaard and Hans-Henrik Parving and Lise Tarnow and Birger Thorsteinsson and Ulrik Pedersen-Bjergaard",

year = "2023",

month = jun,

doi = "10.1111/dom.15003",

language = "English",

volume = "25",

pages = "1557--1565",

journal = "Diabetes, Obesity and Metabolism",

issn = "1462-8902",

publisher = "Wiley-Blackwell Publishing Ltd.",

number = "6",

}

Brøsen, JMB, Agesen, RM, Kristensen, PL, Alibegovic, AC, Andersen, HU, Beck-Nielsen, H, Gustenhoff, P, Hansen, TK, Hedetoft, C, Jensen, T, Stolberg, CR, Juhl, CB, Lerche, SS, Nørgaard, K, Parving, H-H, Tarnow, L, Thorsteinsson, B & Pedersen-Bjergaard, U 2023, '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', Diabetes, Obesity and Metabolism, bind 25, nr. 6, s. 1557-1565. https://doi.org/10.1111/dom.15003

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. / Brøsen, Julie Maria Bøggild; Agesen, Rikke Mette; Kristensen, Peter Lommer et al.
I: Diabetes, Obesity and Metabolism, Bind 25, Nr. 6, 06.2023, s. 1557-1565.

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avis › Tidsskriftartikel › Forskning › peer review

TY - JOUR

T1 - 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

AU - Brøsen, Julie Maria Bøggild

AU - Agesen, Rikke Mette

AU - Kristensen, Peter Lommer

AU - Alibegovic, Amra Ciric

AU - Andersen, Henrik Ullits

AU - Beck-Nielsen, Henning

AU - Gustenhoff, Peter

AU - Hansen, Troels Krarup

AU - Hedetoft, Christoffer

AU - Jensen, Tonny

AU - Stolberg, Charlotte Røn

AU - Juhl, Claus Bogh

AU - Lerche, Susanne Søgaard

AU - Nørgaard, Kirsten

AU - Parving, Hans-Henrik

AU - Tarnow, Lise

AU - Thorsteinsson, Birger

AU - Pedersen-Bjergaard, Ulrik

PY - 2023/6

Y1 - 2023/6

N2 - AIMS: Nocturnal glucose control in people with type 1 diabetes on multiple daily injection therapy is hampered by the risk of hypoglycaemia. Insulin degludec lowers the risk of patient-reported and continuous glucose monitoring-recorded nocturnal hypoglycaemia. In a cohort of people with type 1 diabetes prone to nocturnal severe hypoglycaemia, we compared nocturnal glucose profiles by hourly plasma glucose measurements during treatment with insulin degludec and insulin glargine U100.MATERIALS AND METHODS: The HypoDeg trial is a 2-year investigator-initiated, randomised, controlled crossover trial in 149 participants randomised to treatment with insulin degludec and insulin glargine U100 for 12 months each. The 51 participants in this pre-defined sub-study stayed at least one night during each treatment arm in-hospital for plasma glucose samples. 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 to insulin glargine U100, which had a nadir at 04:00 with a subsequent rise. During treatment with insulin degludec, the participants had a lower glycaemic variability with an estimated treatment difference of -4.3% ([95% CI: -8.1 - -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 to insulin glargine U100 administered in the evening results in lower glycaemic variability and lower risk of nocturnal hypoglycaemia without differences in mean plasma glucose. This article is protected by copyright. All rights reserved.

AB - AIMS: Nocturnal glucose control in people with type 1 diabetes on multiple daily injection therapy is hampered by the risk of hypoglycaemia. Insulin degludec lowers the risk of patient-reported and continuous glucose monitoring-recorded nocturnal hypoglycaemia. In a cohort of people with type 1 diabetes prone to nocturnal severe hypoglycaemia, we compared nocturnal glucose profiles by hourly plasma glucose measurements during treatment with insulin degludec and insulin glargine U100.MATERIALS AND METHODS: The HypoDeg trial is a 2-year investigator-initiated, randomised, controlled crossover trial in 149 participants randomised to treatment with insulin degludec and insulin glargine U100 for 12 months each. The 51 participants in this pre-defined sub-study stayed at least one night during each treatment arm in-hospital for plasma glucose samples. 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 to insulin glargine U100, which had a nadir at 04:00 with a subsequent rise. During treatment with insulin degludec, the participants had a lower glycaemic variability with an estimated treatment difference of -4.3% ([95% CI: -8.1 - -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 to insulin glargine U100 administered in the evening results in lower glycaemic variability and lower risk of nocturnal hypoglycaemia without differences in mean plasma glucose. This article is protected by copyright. All rights reserved.

KW - basal insulin

KW - clinical trial

KW - glycaemic control

KW - hypoglycaemia

KW - insulin analogues

KW - type 1 diabetes

UR - http://www.scopus.com/inward/record.url?scp=85149986760&partnerID=8YFLogxK

U2 - 10.1111/dom.15003

DO - 10.1111/dom.15003

M3 - Journal article

C2 - 36749303

SN - 1462-8902

VL - 25

SP - 1557

EP - 1565

JO - Diabetes, Obesity and Metabolism

JF - Diabetes, Obesity and Metabolism

IS - 6

ER -

Brøsen JMB, Agesen RM, Kristensen PL, Alibegovic AC, Andersen HU, Beck-Nielsen H et al. 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. Diabetes, Obesity and Metabolism. 2023 jun.;25(6):1557-1565. Epub 2023 feb. 7. doi: 10.1111/dom.15003

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

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