Comparing effects of insulin analogues and human insulin on nocturnal glycaemia in hypoglycaemia-prone people with Type 1 diabetes

P. L. Kristensen*, L Tarnow, Christiane Bay, K Nørgaard, T Jensen, H.-H. Parving, H. Perrild, H. Beck-Nielsen, J S Christiansen, B. Thorsteinsson, Ulrik Pedersen-Bjergaard

*Kontaktforfatter for dette arbejde

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Resumé

Aims: To assess the difference between analogue and human insulin with regard to nocturnal glucose profiles and risk of hypoglycaemia in people with recurrent severe hypoglycaemia. Methods: A total of 72 people [46 men, mean ± sd age 54 ± 12 years, mean ± sd HbA1c 65 ± 12 mmol/mol (8.1 ± 1.1%), mean ± sd duration of diabetes 30 ± 14 years], who participated in a 2-year randomized, crossover trial of basal-bolus therapy with insulin detemir/insulin aspart or human NPH insulin/human regular insulin (the HypoAna trial) were studied for 2 nights during each treatment. Venous blood was drawn hourly during sleep. Primary endpoints were nocturnal glucose profiles and occurrence of hypoglycaemia (blood glucose ≤ 3.9 mmol/l). Results: During insulin analogue treatment, the mean nocturnal plasma glucose level was significantly higher than during treatment with human insulin (10.6 vs 8.1 mmol/l). The fasting plasma glucose level was similar between the treatments. Nocturnal hypoglycaemia was registered during 41/101 nights (41%) in the human insulin arm and 19/117 nights (16%) in the insulin analogue arm, corresponding to a hazard ratio of 0.26 (95% CI 0.14 to 0.45; P < 0.0001) with insulin analogue. Conclusions: Treatment with insulin analogue reduces the occurrence of nocturnal hypoglycaemia assessed by nocturnal glucose profiles in people with Type 1 diabetes prone to severe hypoglycaemia. Nocturnal glucose profiles provide a more comprehensive assessment of clinical benefit of insulin regimens as compared to conventional recording of hypoglycaemia.

OriginalsprogEngelsk
TidsskriftDiabetic Medicine
Vol/bind34
Udgave nummer5
Sider (fra-til)625–631
ISSN0742-3071
DOI
StatusUdgivet - maj 2017

Fingeraftryk

Hypoglycemia
Insulin
Insulin, Regular, Human
Insulin Aspart
Cross-Over Studies
Fasting

Citer dette

Kristensen, P. L., Tarnow, L., Bay, C., Nørgaard, K., Jensen, T., Parving, H-H., ... Pedersen-Bjergaard, U. (2017). Comparing effects of insulin analogues and human insulin on nocturnal glycaemia in hypoglycaemia-prone people with Type 1 diabetes. Diabetic Medicine, 34(5), 625–631. https://doi.org/10.1111/dme.13317
Kristensen, P. L. ; Tarnow, L ; Bay, Christiane ; Nørgaard, K ; Jensen, T ; Parving, H.-H. ; Perrild, H. ; Beck-Nielsen, H. ; Christiansen, J S ; Thorsteinsson, B. ; Pedersen-Bjergaard, Ulrik. / Comparing effects of insulin analogues and human insulin on nocturnal glycaemia in hypoglycaemia-prone people with Type 1 diabetes. I: Diabetic Medicine. 2017 ; Bind 34, Nr. 5. s. 625–631.
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title = "Comparing effects of insulin analogues and human insulin on nocturnal glycaemia in hypoglycaemia-prone people with Type 1 diabetes",
abstract = "Aims: To assess the difference between analogue and human insulin with regard to nocturnal glucose profiles and risk of hypoglycaemia in people with recurrent severe hypoglycaemia. Methods: A total of 72 people [46 men, mean ± sd age 54 ± 12 years, mean ± sd HbA1c 65 ± 12 mmol/mol (8.1 ± 1.1{\%}), mean ± sd duration of diabetes 30 ± 14 years], who participated in a 2-year randomized, crossover trial of basal-bolus therapy with insulin detemir/insulin aspart or human NPH insulin/human regular insulin (the HypoAna trial) were studied for 2 nights during each treatment. Venous blood was drawn hourly during sleep. Primary endpoints were nocturnal glucose profiles and occurrence of hypoglycaemia (blood glucose ≤ 3.9 mmol/l). Results: During insulin analogue treatment, the mean nocturnal plasma glucose level was significantly higher than during treatment with human insulin (10.6 vs 8.1 mmol/l). The fasting plasma glucose level was similar between the treatments. Nocturnal hypoglycaemia was registered during 41/101 nights (41{\%}) in the human insulin arm and 19/117 nights (16{\%}) in the insulin analogue arm, corresponding to a hazard ratio of 0.26 (95{\%} CI 0.14 to 0.45; P < 0.0001) with insulin analogue. Conclusions: Treatment with insulin analogue reduces the occurrence of nocturnal hypoglycaemia assessed by nocturnal glucose profiles in people with Type 1 diabetes prone to severe hypoglycaemia. Nocturnal glucose profiles provide a more comprehensive assessment of clinical benefit of insulin regimens as compared to conventional recording of hypoglycaemia.",
keywords = "Adult, Aged, Blood Glucose/drug effects, Circadian Rhythm/drug effects, Cross-Over Studies, Diabetes Mellitus, Type 1/blood, Female, Humans, Hypoglycemia/chemically induced, Insulin Aspart/administration & dosage, Insulin, Isophane/administration & dosage, Insulin, Long-Acting/administration & dosage, Insulin/administration & dosage, Male, Middle Aged, Treatment Outcome, Young Adult",
author = "Kristensen, {P. L.} and L Tarnow and Christiane Bay and K N{\o}rgaard and T Jensen and H.-H. Parving and H. Perrild and H. Beck-Nielsen and Christiansen, {J S} and B. Thorsteinsson and Ulrik Pedersen-Bjergaard",
year = "2017",
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doi = "10.1111/dme.13317",
language = "English",
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pages = "625–631",
journal = "Diabetic Medicine",
issn = "0742-3071",
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Kristensen, PL, Tarnow, L, Bay, C, Nørgaard, K, Jensen, T, Parving, H-H, Perrild, H, Beck-Nielsen, H, Christiansen, JS, Thorsteinsson, B & Pedersen-Bjergaard, U 2017, 'Comparing effects of insulin analogues and human insulin on nocturnal glycaemia in hypoglycaemia-prone people with Type 1 diabetes', Diabetic Medicine, bind 34, nr. 5, s. 625–631. https://doi.org/10.1111/dme.13317

Comparing effects of insulin analogues and human insulin on nocturnal glycaemia in hypoglycaemia-prone people with Type 1 diabetes. / Kristensen, P. L.; Tarnow, L; Bay, Christiane; Nørgaard, K; Jensen, T; Parving, H.-H.; Perrild, H.; Beck-Nielsen, H.; Christiansen, J S; Thorsteinsson, B.; Pedersen-Bjergaard, Ulrik.

I: Diabetic Medicine, Bind 34, Nr. 5, 05.2017, s. 625–631.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Comparing effects of insulin analogues and human insulin on nocturnal glycaemia in hypoglycaemia-prone people with Type 1 diabetes

AU - Kristensen, P. L.

AU - Tarnow, L

AU - Bay, Christiane

AU - Nørgaard, K

AU - Jensen, T

AU - Parving, H.-H.

AU - Perrild, H.

AU - Beck-Nielsen, H.

AU - Christiansen, J S

AU - Thorsteinsson, B.

AU - Pedersen-Bjergaard, Ulrik

PY - 2017/5

Y1 - 2017/5

N2 - Aims: To assess the difference between analogue and human insulin with regard to nocturnal glucose profiles and risk of hypoglycaemia in people with recurrent severe hypoglycaemia. Methods: A total of 72 people [46 men, mean ± sd age 54 ± 12 years, mean ± sd HbA1c 65 ± 12 mmol/mol (8.1 ± 1.1%), mean ± sd duration of diabetes 30 ± 14 years], who participated in a 2-year randomized, crossover trial of basal-bolus therapy with insulin detemir/insulin aspart or human NPH insulin/human regular insulin (the HypoAna trial) were studied for 2 nights during each treatment. Venous blood was drawn hourly during sleep. Primary endpoints were nocturnal glucose profiles and occurrence of hypoglycaemia (blood glucose ≤ 3.9 mmol/l). Results: During insulin analogue treatment, the mean nocturnal plasma glucose level was significantly higher than during treatment with human insulin (10.6 vs 8.1 mmol/l). The fasting plasma glucose level was similar between the treatments. Nocturnal hypoglycaemia was registered during 41/101 nights (41%) in the human insulin arm and 19/117 nights (16%) in the insulin analogue arm, corresponding to a hazard ratio of 0.26 (95% CI 0.14 to 0.45; P < 0.0001) with insulin analogue. Conclusions: Treatment with insulin analogue reduces the occurrence of nocturnal hypoglycaemia assessed by nocturnal glucose profiles in people with Type 1 diabetes prone to severe hypoglycaemia. Nocturnal glucose profiles provide a more comprehensive assessment of clinical benefit of insulin regimens as compared to conventional recording of hypoglycaemia.

AB - Aims: To assess the difference between analogue and human insulin with regard to nocturnal glucose profiles and risk of hypoglycaemia in people with recurrent severe hypoglycaemia. Methods: A total of 72 people [46 men, mean ± sd age 54 ± 12 years, mean ± sd HbA1c 65 ± 12 mmol/mol (8.1 ± 1.1%), mean ± sd duration of diabetes 30 ± 14 years], who participated in a 2-year randomized, crossover trial of basal-bolus therapy with insulin detemir/insulin aspart or human NPH insulin/human regular insulin (the HypoAna trial) were studied for 2 nights during each treatment. Venous blood was drawn hourly during sleep. Primary endpoints were nocturnal glucose profiles and occurrence of hypoglycaemia (blood glucose ≤ 3.9 mmol/l). Results: During insulin analogue treatment, the mean nocturnal plasma glucose level was significantly higher than during treatment with human insulin (10.6 vs 8.1 mmol/l). The fasting plasma glucose level was similar between the treatments. Nocturnal hypoglycaemia was registered during 41/101 nights (41%) in the human insulin arm and 19/117 nights (16%) in the insulin analogue arm, corresponding to a hazard ratio of 0.26 (95% CI 0.14 to 0.45; P < 0.0001) with insulin analogue. Conclusions: Treatment with insulin analogue reduces the occurrence of nocturnal hypoglycaemia assessed by nocturnal glucose profiles in people with Type 1 diabetes prone to severe hypoglycaemia. Nocturnal glucose profiles provide a more comprehensive assessment of clinical benefit of insulin regimens as compared to conventional recording of hypoglycaemia.

KW - Adult

KW - Aged

KW - Blood Glucose/drug effects

KW - Circadian Rhythm/drug effects

KW - Cross-Over Studies

KW - Diabetes Mellitus, Type 1/blood

KW - Female

KW - Humans

KW - Hypoglycemia/chemically induced

KW - Insulin Aspart/administration & dosage

KW - Insulin, Isophane/administration & dosage

KW - Insulin, Long-Acting/administration & dosage

KW - Insulin/administration & dosage

KW - Male

KW - Middle Aged

KW - Treatment Outcome

KW - Young Adult

U2 - 10.1111/dme.13317

DO - 10.1111/dme.13317

M3 - Journal article

C2 - 28099755

AN - SCOPUS:85013216779

VL - 34

SP - 625

EP - 631

JO - Diabetic Medicine

JF - Diabetic Medicine

SN - 0742-3071

IS - 5

ER -