title: Comparing effects of insulin analogues and human insulin on nocturnal glycaemia in hypoglycaemia-prone people with Type 1 diabetes.
abstract: 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.
  
  
  
  A total of 72 people [46 men, mean ± sd age 54 ± 12 years, mean ± sd HbA1c65 ± 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).
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Nordsjaellands Hospital Hillerød, Department of Cardiology, Nephrology and Endocrinology, Hillerød, Denmark.
authors.forename: P L
authors.initials: PL
authors.lastname: Kristensen
authors.affiliation: Steno Diabetes Centre, Department of Clinical Research, Gentofte, Denmark.|Health, Aarhus University, Aarhus, Denmark.|Department of Clinical Research, Nordsjaellands Hospital Hillerød, Hillerød, Denmark.
authors.forename: L
authors.initials: L
authors.lastname: Tarnow
authors.affiliation: Nordsjaellands Hospital Hillerød, Department of Cardiology, Nephrology and Endocrinology, Hillerød, Denmark.|Department of Dermatology, Bispebjerg University Hospital, Copenhagen, Denmark.
authors.forename: C
authors.initials: C
authors.lastname: Bay
authors.affiliation: Department of Endocrinology, Hvidovre University Hospital, Hvidovre, Denmark.
authors.forename: K
authors.initials: K
authors.lastname: Nørgaard
authors.affiliation: Department of Endocrinology, Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark.
authors.forename: T
authors.initials: T
authors.lastname: Jensen
authors.affiliation: Health, Aarhus University, Aarhus, Denmark.|Department of Endocrinology, Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark.
authors.forename: H-H
authors.initials: HH
authors.lastname: Parving
authors.affiliation: Department of Endocrinology, Bispebjerg University Hospital, Copenhagen, Denmark.
authors.forename: H
authors.initials: H
authors.lastname: Perrild
authors.affiliation: Department of Endocrinology M, Odense University Hospital, Odense, Denmark.
authors.forename: H
authors.initials: H
authors.lastname: Beck-Nielsen
authors.affiliation: Health, Aarhus University, Aarhus, Denmark.|Department of Endocrinology M, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: J S
authors.initials: JS
authors.lastname: Christiansen
authors.affiliation: Nordsjaellands Hospital Hillerød, Department of Cardiology, Nephrology and Endocrinology, Hillerød, Denmark.|Department of Dermatology, Bispebjerg University Hospital, Copenhagen, Denmark.
authors.forename: B
authors.initials: B
authors.lastname: Thorsteinsson
authors.affiliation: Nordsjaellands Hospital Hillerød, Department of Cardiology, Nephrology and Endocrinology, Hillerød, Denmark.|Department of Dermatology, Bispebjerg University Hospital, Copenhagen, Denmark.
authors.forename: U
authors.initials: U
authors.lastname: Pedersen-Bjergaard
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000187:drug effects* / Q000378:metabolism; D002940:Circadian Rhythm / Q000187:drug effects; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced / Q000453:epidemiology / Q000517:prevention & control*; D007328:Insulin / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D061267:Insulin Aspart / Q000008:administration & dosage / Q000009:adverse effects; D007336:Insulin, Isophane / Q000008:administration & dosage / Q000009:adverse effects; D049528:Insulin, Long-Acting / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D007328:Insulin; D049528:Insulin, Long-Acting; D007336:Insulin, Isophane; D061267:Insulin Aspart