Insulin degludec is not associated with a delayed or diminished response to hypoglycaemia compared with insulin glargine in type 1 diabetes: A double-blind randomised crossover study

Diabetologia

Volumn 57, Issue 1, 2014, Pages 40-49

  Koehler, Gerd ^a   Heller, Simon ^b   Korsatko, Stefan ^a   Roepstorff, Carsten ^c   Rasmussen, Søren ^c   Haahr, Hanne ^c   Pieber, Thomas R ^a  

^a MEDICAL UNIVERSITY OF GRAZ   (Austria)

^b UNIVERSITY OF SHEFFIELD   (United Kingdom)

^c NOVO NORDISK A S   (Denmark)

Author keywords

Counter regulation; Degludec; Glargine; Hormones; Hypoglycaemia; Type 1 diabetes

Indexed keywords

ADRENALIN; GROWTH HORMONE; HEMOGLOBIN A1C; HYDROCORTISONE; INSULIN ASPART; INSULIN DEGLUDEC; INSULIN GLARGINE;

ADRENALIN BLOOD LEVEL; ADULT; AGED; ANAPHYLAXIS; ARTICLE; AWARENESS; CLINICAL ARTICLE; COGNITION; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIASTOLIC BLOOD PRESSURE; DOUBLE BLIND PROCEDURE; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ELECTROCARDIOGRAM; ERYTHEMA; FACE EDEMA; FEMALE; FOLLOW UP; GLUCOSE BLOOD LEVEL; GLUCOSE INFUSION; GROWTH HORMONE BLOOD LEVEL; HEADACHE; HORMONE RESPONSE; HUMAN; HYDROCORTISONE BLOOD LEVEL; HYPOGLYCEMIA; INFLUENZA; INSULIN DEPENDENT DIABETES MELLITUS; MALE; MIDDLE AGED; MYOPIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SYSTOLIC BLOOD PRESSURE; VITAL SIGN; YOUNG ADULT;

ADULT; BLOOD GLUCOSE; CROSS-OVER STUDIES; DIABETES MELLITUS, TYPE 1; DOUBLE-BLIND METHOD; FEMALE; HUMANS; HYPOGLYCEMIA; INSULIN, LONG-ACTING; MALE; MIDDLE AGED;

EID: 84890922583     PISSN: 0012186X     EISSN: 14320428     Source Type: Journal    
DOI: 10.1007/s00125-013-3056-0     Document Type: Article

References (32)

1. UK Hypoglycaemia Study Group (2007) Risk of hypoglycaemia in types 1 and 2 diabetes: effects of treatment modalities and their duration. Diabetologia 50:1140-1147
2. Gold AE, MacLeod KM, Frier BM (1994) Frequency of severe hypoglycemia in patients with type I diabetes with impaired awareness of hypoglycemia. Diabetes Care 17:697-703
3. McCrimmon RJ, Sherwin RS (2010) Hypoglycemia in type 1 diabetes. Diabetes 59:2333-2339
4. Jonassen I, Havelund S, Hoeg-Jensen T et al (2012) Design of the novel protraction mechanism of insulin degludec, an ultra-long-acting basal insulin. Pharm Res 29:2104-2114
5. Gough SCL, Harris S, Woo V, Davies M (2013) Insulin degludec: overview of a novel ultra long-acting basal insulin. Diabetes Obes Metab 15:301-309
6. Heise T, Hermanski L, Nosek L et al (2012) Insulin degludec: four times lower pharmacodynamic variability than insulin glargine under steady-state conditions in type 1 diabetes. Diabetes Obes Metab 14:859-864
7. Garber AJ, King AB, del Prato S et al (2012) Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 2 diabetes (BEGIN Basal-Bolus Type 2): a phase 3, randomised, open-label, treat-to-target non-inferiority trial. Lancet 379:1498-1507
8. Heller S, Buse J, Fisher M et al (2012) Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 1 diabetes (BEGIN Basal-Bolus Type 1): a phase 3, randomised, open-label, treat-to-target non-inferiority trial. Lancet 379:1489-1497
9. Ratner RE, Gough SCL, Mathieu C et al (2013) Hypoglycaemia risk with insulin degludec compared with insulin glargine in type 2 and type 1 diabetes: a pre-planned meta-analysis of phase 3 trials. Diabetes Obes Metab 15:175-184
10. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (2001) ICH harmonised tripartite guideline: guideline for good clinical practice. J Postgrad Med 47:45-50
11. World Medical Association (2009) Declaration of Helsinki. Ethical principles for medical research involving human subjects. J Indian Med Assoc 107:403-405
12. McAulay V, Deary I, Frier BM (2001) Symptoms of hypoglycaemia in people with diabetes. Diabet Med 18:690-705
13. Heller S (1999) Diabetic hypoglycaemia. Baillière's Best Pract Res Clin Endocrinol Metab 13:279-294
14. Deary IJ (2007) Symptoms of hypoglycaemia and effects on mental performance and emotions. In: Frier BM, Fisher M (eds) Hypoglycaemia in clinical diabetes, 2nd edn. Wiley, Chichester. doi: 10.1002/9780470516270.ch2
15. Bowie CR, Harvey PD (2006) Administration and interpretation of the Trail Making Test. Nat Protoc 1:2277-2281
16. Reitan RM, Davison LA (1974) Clinical neuropsychology: current status and applications. V. H. Winston & Sons, Washington, DC
17. Wechsler D (1981) WAIS-R manual: Wechsler adult intelligence scale-revised. Psychological Cooperation, New York
18. Wilkinson RT, Houghton D (1975) Portable four-choice reaction time test with magnetic tape memory. Behav Res Methods Instrum 7:441-446
19. Smeeton F, Shojaee-Moradie F, Jones RH et al (2009) Differential effects of insulin detemir and neutral protamine Hagedorn (NPH) insulin on hepatic glucose production and peripheral glucose uptake during hypoglycaemia in type 1 diabetes. Diabetologia 52:2317-2323
20. Tschritter O, Schäfer SA, Klett J et al (2009) Insulin detemir causes increased symptom awareness during hypoglycaemia compared to human insulin. Diabetes Obes Metab 11:1017-1026
21. Galassetti P, Davis SN (2000) Effects of insulin per se on neuroendocrine and metabolic counter-regulatory responses to hypoglycaemia. Clin Sci 99:351-362
22. Rossetti P, Porcellati F, Ricci NB et al (2008) Different brain responses to hypoglycemia induced by equipotent doses of the long-acting insulin analog detemir and human regular insulin in humans. Diabetes 57:746-756
23. Frier BM (2001) Hypoglycaemia and cognitive function in diabetes. Int J Clin Pract (S123):30-37
24. Dagogo-Jack S, Askari H, Morrill B et al (2000) Physiological responses during hypoglycaemia induced by regular human insulin or a novel human analogue, insulin glargine. Diabetes Obes Metab 2:373-383
25. Frier BM, Ewing FM, Lindholm A, Hylleberg B, Kanc K (2000) Symptomatic and counterregulatory hormonal responses to acute hypoglycaemia induced by insulin aspart and soluble human insulin in type 1 diabetes. Diabetes Metab Res Rev 16:262-268
26. Davis SN, Shavers C, Costa F, Mosqueda-Garcia R (1996) Role of cortisol in the pathogenesis of deficient counterregulation after antecedent hypoglycemia in normal humans. J Clin Invest 98:680-691
27. Raju B, McGregor VP, Cryer PE (2003) Cortisol elevations comparable to those that occur during hypoglycemia do not cause hypoglycemia-associated autonomic failure. Diabetes 52:2083-2089
28. Goldberg PA, Weiss R, McCrimmon RJ et al (2006) Autonomic failure. Diabetes 55:1121-1126
29. Ratner RE (2003) Insulin glargine versus NPH insulin in patients with type 1 diabetes. Drugs Today 39:867-876
30. Fanelli CG, Pampanelli S, Epifano L et al (1994) Long-term recovery from unawareness, deficient counterregulation and lack of cognitive dysfunction during hypoglycaemia, following institution of rational, intensive insulin therapy in IDDM. Diabetologia 37:1265-1276
31. Birkeland KI, Home PD, Wendisch U et al (2011) Insulin degludec in type 1 diabetes: a randomized controlled trial of a new-generation ultra-long-acting insulin compared with insulin glargine. Diabetes Care 34:661-665
32. Zinman B, Fulcher G, Rao PV et al (2011) Insulin degludec, an ultra-long-acting basal insulin, once a day or three times a week versus insulin glargine once a day in patients with type 2 diabetes: a 16-week, randomised, open-label, phase 2 trial. Lancet 377:924-931