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

R M Agesen, P L Kristensen, H Beck-Nielsen, K Nørgaard, H Perrild, J S Christiansen, T Jensen, P Hougaard, H H Parving, B Thorsteinsson, L Tarnow, U Pedersen-Bjergaard

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

AIM: Insulin analogues reduce the risk of hypoglycaemia compared with human insulin in patients with type 1 diabetes (T1D) and minor hypoglycaemia problems. The HypoAna trial showed that, in patients with recurrent severe hypoglycaemia, treatment based on insulin analogues reduces the risk of severe hypoglycaemia. The present study aims to assess whether this also applies to non-severe hypoglycaemia events during the day and at night.

METHODS: This 2-year investigator-initiated multicentre, prospective, randomized, open, blinded endpoint (PROBE) trial involved patients with T1D and at least two episodes of severe hypoglycaemia during the previous year. Using a balanced crossover design, patients were randomized to basal-bolus therapy based on analogue (detemir/aspart) or human (NPH/regular) insulins. A total of 114 participants were included. Endpoints were the number of severe hypoglycaemic events and non-severe events, including documented symptomatic and asymptomatic episodes occurring during the day and at night (ClinicalTrials.gov number: NCT00346996).

RESULTS: Analogue-based treatment resulted in a 6% (2-10%; P=0.0025) overall relative risk reduction of non-severe hypoglycaemia. This was due to a 39% (32-46%; P<0.0001) reduction of non-severe nocturnal hypoglycaemia, seen for both symptomatic (48% [36-57%]; P<0.0001) and asymptomatic (28% [14-39%]; P=0.0004) nocturnal hypoglycaemia episodes. No clinically significant differences in hypoglycaemia occurrence were observed between the insulin regimens during the day. The time needed to treat one patient with insulin analogues to avoid one episode (TNT1) of non-severe nocturnal hypoglycaemia was approximately 3 months.

CONCLUSION: In T1D patients prone to severe hypoglycaemia, treatment with analogue insulin reduced the risk of non-severe nocturnal hypoglycaemia compared with human insulin.

OriginalsprogEngelsk
TidsskriftDiabetes & Metabolism
Vol/bind42
Udgave nummer2
Sider (fra-til)249-255
ISSN1262-3636
DOI
StatusUdgivet - 7. apr. 2016

Fingeraftryk

Hypoglycemia
Insulin
Risk Reduction Behavior
Hypoglycemic Agents
Cross-Over Studies
Research Personnel

Citer dette

Agesen, R M ; Kristensen, P L ; Beck-Nielsen, H ; Nørgaard, K ; Perrild, H ; Christiansen, J S ; Jensen, T ; Hougaard, P ; Parving, H H ; Thorsteinsson, B ; Tarnow, L ; Pedersen-Bjergaard, U. / Effect of insulin analogues on frequency of non-severe hypoglycaemia in patients with type 1 diabetes prone to severe hypoglycaemia : The HypoAna trial. I: Diabetes & Metabolism. 2016 ; Bind 42, Nr. 2. s. 249-255.
@article{2291f1b5cf884cfa9a5d918e87c68a9f,
title = "Effect of insulin analogues on frequency of non-severe hypoglycaemia in patients with type 1 diabetes prone to severe hypoglycaemia: The HypoAna trial",
abstract = "AIM: Insulin analogues reduce the risk of hypoglycaemia compared with human insulin in patients with type 1 diabetes (T1D) and minor hypoglycaemia problems. The HypoAna trial showed that, in patients with recurrent severe hypoglycaemia, treatment based on insulin analogues reduces the risk of severe hypoglycaemia. The present study aims to assess whether this also applies to non-severe hypoglycaemia events during the day and at night.METHODS: This 2-year investigator-initiated multicentre, prospective, randomized, open, blinded endpoint (PROBE) trial involved patients with T1D and at least two episodes of severe hypoglycaemia during the previous year. Using a balanced crossover design, patients were randomized to basal-bolus therapy based on analogue (detemir/aspart) or human (NPH/regular) insulins. A total of 114 participants were included. Endpoints were the number of severe hypoglycaemic events and non-severe events, including documented symptomatic and asymptomatic episodes occurring during the day and at night (ClinicalTrials.gov number: NCT00346996).RESULTS: Analogue-based treatment resulted in a 6{\%} (2-10{\%}; P=0.0025) overall relative risk reduction of non-severe hypoglycaemia. This was due to a 39{\%} (32-46{\%}; P<0.0001) reduction of non-severe nocturnal hypoglycaemia, seen for both symptomatic (48{\%} [36-57{\%}]; P<0.0001) and asymptomatic (28{\%} [14-39{\%}]; P=0.0004) nocturnal hypoglycaemia episodes. No clinically significant differences in hypoglycaemia occurrence were observed between the insulin regimens during the day. The time needed to treat one patient with insulin analogues to avoid one episode (TNT1) of non-severe nocturnal hypoglycaemia was approximately 3 months.CONCLUSION: In T1D patients prone to severe hypoglycaemia, treatment with analogue insulin reduced the risk of non-severe nocturnal hypoglycaemia compared with human insulin.",
author = "Agesen, {R M} and Kristensen, {P L} and H Beck-Nielsen and K N{\o}rgaard and H Perrild and Christiansen, {J S} and T Jensen and P Hougaard and Parving, {H H} and B Thorsteinsson and L Tarnow and U Pedersen-Bjergaard",
note = "Copyright {\circledC} 2016 Elsevier Masson SAS. All rights reserved.",
year = "2016",
month = "4",
day = "7",
doi = "10.1016/j.diabet.2016.03.001",
language = "English",
volume = "42",
pages = "249--255",
journal = "Diabetes & Metabolism",
issn = "1262-3636",
publisher = "Elsevier Masson",
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Agesen, RM, Kristensen, PL, Beck-Nielsen, H, Nørgaard, K, Perrild, H, Christiansen, JS, Jensen, T, Hougaard, P, Parving, HH, Thorsteinsson, B, Tarnow, L & Pedersen-Bjergaard, U 2016, 'Effect of insulin analogues on frequency of non-severe hypoglycaemia in patients with type 1 diabetes prone to severe hypoglycaemia: The HypoAna trial', Diabetes & Metabolism, bind 42, nr. 2, s. 249-255. https://doi.org/10.1016/j.diabet.2016.03.001

Effect of insulin analogues on frequency of non-severe hypoglycaemia in patients with type 1 diabetes prone to severe hypoglycaemia : The HypoAna trial. / Agesen, R M; Kristensen, P L; Beck-Nielsen, H; Nørgaard, K; Perrild, H; Christiansen, J S; Jensen, T; Hougaard, P; Parving, H H; Thorsteinsson, B; Tarnow, L; Pedersen-Bjergaard, U.

I: Diabetes & Metabolism, Bind 42, Nr. 2, 07.04.2016, s. 249-255.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Effect of insulin analogues on frequency of non-severe hypoglycaemia in patients with type 1 diabetes prone to severe hypoglycaemia

T2 - The HypoAna trial

AU - Agesen, R M

AU - Kristensen, P L

AU - Beck-Nielsen, H

AU - Nørgaard, K

AU - Perrild, H

AU - Christiansen, J S

AU - Jensen, T

AU - Hougaard, P

AU - Parving, H H

AU - Thorsteinsson, B

AU - Tarnow, L

AU - Pedersen-Bjergaard, U

N1 - Copyright © 2016 Elsevier Masson SAS. All rights reserved.

PY - 2016/4/7

Y1 - 2016/4/7

N2 - AIM: Insulin analogues reduce the risk of hypoglycaemia compared with human insulin in patients with type 1 diabetes (T1D) and minor hypoglycaemia problems. The HypoAna trial showed that, in patients with recurrent severe hypoglycaemia, treatment based on insulin analogues reduces the risk of severe hypoglycaemia. The present study aims to assess whether this also applies to non-severe hypoglycaemia events during the day and at night.METHODS: This 2-year investigator-initiated multicentre, prospective, randomized, open, blinded endpoint (PROBE) trial involved patients with T1D and at least two episodes of severe hypoglycaemia during the previous year. Using a balanced crossover design, patients were randomized to basal-bolus therapy based on analogue (detemir/aspart) or human (NPH/regular) insulins. A total of 114 participants were included. Endpoints were the number of severe hypoglycaemic events and non-severe events, including documented symptomatic and asymptomatic episodes occurring during the day and at night (ClinicalTrials.gov number: NCT00346996).RESULTS: Analogue-based treatment resulted in a 6% (2-10%; P=0.0025) overall relative risk reduction of non-severe hypoglycaemia. This was due to a 39% (32-46%; P<0.0001) reduction of non-severe nocturnal hypoglycaemia, seen for both symptomatic (48% [36-57%]; P<0.0001) and asymptomatic (28% [14-39%]; P=0.0004) nocturnal hypoglycaemia episodes. No clinically significant differences in hypoglycaemia occurrence were observed between the insulin regimens during the day. The time needed to treat one patient with insulin analogues to avoid one episode (TNT1) of non-severe nocturnal hypoglycaemia was approximately 3 months.CONCLUSION: In T1D patients prone to severe hypoglycaemia, treatment with analogue insulin reduced the risk of non-severe nocturnal hypoglycaemia compared with human insulin.

AB - AIM: Insulin analogues reduce the risk of hypoglycaemia compared with human insulin in patients with type 1 diabetes (T1D) and minor hypoglycaemia problems. The HypoAna trial showed that, in patients with recurrent severe hypoglycaemia, treatment based on insulin analogues reduces the risk of severe hypoglycaemia. The present study aims to assess whether this also applies to non-severe hypoglycaemia events during the day and at night.METHODS: This 2-year investigator-initiated multicentre, prospective, randomized, open, blinded endpoint (PROBE) trial involved patients with T1D and at least two episodes of severe hypoglycaemia during the previous year. Using a balanced crossover design, patients were randomized to basal-bolus therapy based on analogue (detemir/aspart) or human (NPH/regular) insulins. A total of 114 participants were included. Endpoints were the number of severe hypoglycaemic events and non-severe events, including documented symptomatic and asymptomatic episodes occurring during the day and at night (ClinicalTrials.gov number: NCT00346996).RESULTS: Analogue-based treatment resulted in a 6% (2-10%; P=0.0025) overall relative risk reduction of non-severe hypoglycaemia. This was due to a 39% (32-46%; P<0.0001) reduction of non-severe nocturnal hypoglycaemia, seen for both symptomatic (48% [36-57%]; P<0.0001) and asymptomatic (28% [14-39%]; P=0.0004) nocturnal hypoglycaemia episodes. No clinically significant differences in hypoglycaemia occurrence were observed between the insulin regimens during the day. The time needed to treat one patient with insulin analogues to avoid one episode (TNT1) of non-severe nocturnal hypoglycaemia was approximately 3 months.CONCLUSION: In T1D patients prone to severe hypoglycaemia, treatment with analogue insulin reduced the risk of non-severe nocturnal hypoglycaemia compared with human insulin.

U2 - 10.1016/j.diabet.2016.03.001

DO - 10.1016/j.diabet.2016.03.001

M3 - Journal article

C2 - 27068361

VL - 42

SP - 249

EP - 255

JO - Diabetes & Metabolism

JF - Diabetes & Metabolism

SN - 1262-3636

IS - 2

ER -