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

被引:6
作者
Brosen, Julie Maria Boggild [1 ,2 ]
Agesen, Rikke Mette [1 ,2 ]
Kristensen, Peter Lommer [1 ,2 ]
Alibegovic, Amra Ciric [3 ]
Andersen, Henrik Ullits [2 ,3 ]
Beck-Nielsen, Henning [4 ,5 ]
Gustenhoff, Peter [6 ]
Hansen, Troels Krarup [7 ,8 ]
Hedetoft, Christoffer [9 ]
Jensen, Tonny [10 ]
Stolberg, Charlotte Ron [4 ,5 ,11 ]
Juhl, Claus Bogh [5 ,11 ,12 ]
Lerche, Susanne Sogaard [13 ]
Norgaard, Kirsten [2 ,3 ,14 ]
Parving, Hans-Henrik [2 ,10 ]
Tarnow, Lise [15 ,16 ]
Thorsteinsson, Birger [1 ,2 ]
Pedersen-Bjergaard, Ulrik [1 ,2 ]
机构
[1] Copenhagen Univ Hosp Nordsjaelland, Dept Endocrinol & Nephrol, DK-3400 Hillerod, Denmark
[2] Univ Copenhagen, Fac Hlth & Med Sci, Dept Clin Med, Copenhagen, Denmark
[3] Steno Diabet Ctr Copenhagen, Herlev, Denmark
[4] Odense Univ Hosp, Dept Endocrinol, Odense, Denmark
[5] Univ Southern Denmark, Fac Hlth & Sci, Dept Reg Hlth Res, Odense, Denmark
[6] Steno Diabet Ctr North, Aalborg, Denmark
[7] Aarhus Univ, Dept Clin Med, Aarhus, Denmark
[8] Steno Diabet Ctr Aarhus, Aarhus, Denmark
[9] Zealand Univ Hosp, Dept Internal Med, Koge, Denmark
[10] Copenhagen Univ Hosp, Rigshosp, Dept Med Endocrinol, Copenhagen, Denmark
[11] Univ Hosp South West Jutland, Dept Med, Esbjerg, Denmark
[12] Steno Diabet Ctr Odense, Odense, Denmark
[13] Lillebaelt Hosp Kolding, Dept Diabet & Hormonal Dis, Kolding, Denmark
[14] Copenhagen Univ Hosp Amager & Hvidovre, Dept Endocrinol, Hvidovre, Denmark
[15] Steno Diabet Ctr Sjaelland, Holbaek, Denmark
[16] Copenhagen Univ Hosp Nordsjaelland, Dept Clin Res, Hillerod, Denmark
关键词
basal insulin; clinical trial; glycaemic control; hypoglycaemia; insulin analogues; type; 1; diabetes; OPEN-LABEL; FREQUENCY; AWARENESS; ANALOGS; STATE;
D O I
10.1111/dom.15003
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
引用
收藏
页码:1557 / 1565
页数:9
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