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

被引：12

作者：

Pedersen-Bjergaard, Ulrik ^{[1
,2
]}

Agesen, Rikke M. ^{[1
,2
]}

Brosen, Julie M. B. ^{[1
,2
]}

Alibegovic, Amra C. ^{[3
]}

Andersen, Henrik U. ^{[3
]}

Beck-Nielsen, Henning ^{[4
,5
]}

Gustenhoff, Peter ^{[6
]}

Hansen, Troels K. ^{[7
,8
]}

Hedetoft, Christoffer ^{[9
]}

Jensen, Tonny J. ^{[10
,13
]}

Juhl, Claus B. ^{[11
]}

Jensen, Andreas K. ^{[12
]}

Lerche, Susanne S. ^{[14
]}

Norgaard, Kirsten ^{[1
,3
,15
]}

Parving, Hans-Henrik

Sorensen, Anne L. ^{[12
]}

Tarnow, Lise ^{[13
,16
]}

Thorsteinsson, Birger ^{[1
,2
]}

机构：

[1] Nordsjaellands Hosp, Dept Endocrinol & Nephrol, Hillerod, Denmark

[2] Univ Copenhagen, Fac Hlth & Med Sci, Copenhagen, Denmark

[3] Steno Diabet Ctr Copenhagen, Gentofte, Denmark

[4] Odense Univ Hosp, Dept Endocrinol M, Odense C, Denmark

[5] Univ Southern Denmark, Fac Hlth Sci, Odense C, Denmark

[6] Aalborg Univ Hosp, Dept Endocrinol, Aalborg, Denmark

[7] Steno Diabet Ctr Aarhus, Aarhus N, Denmark

[8] Univ Aarhus, Hlth, Aarhus C, Denmark

[9] Zealand Univ Hosp Koge, Dept Internal Med, Koge, Denmark

[10] Copenhagen Univ Hosp, Rigshosp, Dept Med Endocrinol, Copenhagen, Denmark

[11] Sydvestjysk Sygehus, Dept Med, Esbjerg, Denmark

[12] Univ Copenhagen, Sect Biostat, Dept Publ Hlth, Copenhagen, Denmark

[13] Nordsjaellands Hosp, Dept Clin Res, Hillerod, Denmark

[14] Lillebaelt Hosp Kolding, Dept Diabet & Hormonal Dis, Kolding, Denmark

[15] Hvidovre Univ Hosp, Dept Endocrinol, Hvidovre, Denmark

[16] Steno Diabet Ctr Sjaelland, Holbaek, Denmark

来源：

DIABETES OBESITY & METABOLISM | 2022年 / 24卷 / 02期

关键词：

basal insulin; hypoglycaemia; insulin analogues; phase IV study; randomized trial; type; 1; diabetes; ANALOGS; FREQUENCY; AWARENESS; ASSOCIATION; MANAGEMENT; PHASE-3; ADULTS; RISK;

D O I：

10.1111/dom.14574

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页码：257 / 267

页数：11

共 29 条

[1] Effect of insulin analogues on frequency of non-severe hypoglycaemia in patients with type 1 diabetes prone to severe hypoglycaemia: The HypoAna trial [J].