A prospective randomised cross-over study of the effect of insulin analogues and human insulin on the frequency of severe hypoglycaemia in patients with type 1 diabetes and recurrent hypoglycaemia (the HypoAna trial): study rationale and design

BMC Endocrine Disorders

Lise Tarnow³  Birger Thorsteinsson⁸  Hans-Henrik Parving³  Tonny Jensen⁴  Jens Sandahl Christiansen³  Hans Perrild⁶  Kirsten Nørgaard²  Henning Beck-Nielsen¹  Ulrik Pedersen-Bjergaard⁵  Peter Lommer Kristensen⁷ 

[1]Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark

[2]Department of Endocrinology, Hvidovre University Hospital, Hvidovre, Denmark

[3]Faculty of Health Sciences, University of Aarhus, Aarhus, Denmark

[4]Department of Medical Endocrinology, Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark

[5]Department of Cardiology, Nephrology and Endocrinology, Hillerød University Hospital, Dyrehavevej 29, DK-3400, Hillerød, Denmark

[6]Department of Internal Medicine, Bispebjerg University Hospital, Copenhagen, Denmark

[7]Steno Diabetes Center, Gentofte, Denmark

[8]Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark

关键词: PROBE;    Insulin analogues;    Human insulin;    Severe hypoglycaemia;    Type 1 diabetes;   

Others  :  1086392
DOI  :  10.1186/1472-6823-12-10

 received in 2011-12-20, accepted in 2012-06-13,  发布年份 2012

【 摘 要 】

Background

Severe hypoglycaemia still represents a significant problem in insulin-treated diabetes. Most patients do not experience severe hypoglycaemia often. However, 20% of patients with type 1 diabetes experience recurrent severe hypoglycaemia corresponding to at least two episodes per year. The effect of insulin analogues on glycaemic control has been documented in large trials, while their effect on the frequency of severe hypoglycaemia is less clear, especially in patients with recurrent severe hypoglycaemia. The HypoAna Trial is designed to investigate whether short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing the occurrence of severe hypoglycaemic episodes in patients with recurrent hypoglycaemia. This paper reports the study design of the HypoAna Trial.

Methods/design

The study is a Danish two-year investigator-initiated, prospective, randomised, open, blinded endpoint (PROBE), multicentre, cross-over trial investigating the effect of insulin analogues versus human insulin on the frequency of severe hypoglycaemia in subjects with type 1 diabetes. Patients are randomised to treatment with basal-bolus therapy with insulin detemir / insulin aspart or human NPH insulin / human regular insulin in random order. The major inclusion criterion is history of two or more episodes of severe hypoglycaemia in the preceding year.

Discussion

In contrast to almost all other studies in this field the HypoAna Trial includes only patients with major problems with hypoglycaemia. The HypoAna Trial will elucidate whether basal-bolus regimen with short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing occurrence of severe hypoglycaemic episodes in hypoglycaemia prone patients with type 1 diabetes. http://www.clinicaltrials.gov webcite: NCT00346996.

【 授权许可】

   
2012 Kristensen et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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