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

Peter Lommer Kristensen; Ulrik Pedersen-Bjergaard; Henning Beck-Nielsen; Kirsten Nørgaard; Hans Perrild; Jens Sandahl Christiansen; Tonny Jensen; Hans-Henrik Parving; Birger Thorsteinsson; Lise Tarnow

doi:10.1186/1472-6823-12-10

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

Peter Lommer Kristensen, Ulrik Pedersen-Bjergaard, Henning Beck-Nielsen, Kirsten Nørgaard, Hans Perrild, Jens Sandahl Christiansen, Tonny Jensen, Hans-Henrik Parving, Birger Thorsteinsson, Lise Tarnow

17 Citations (Scopus)

Abstract

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: NCT00346996.

Original language	English
Journal	B M C Endocrine Disorders
Volume	12
Pages (from-to)	10
ISSN	1472-6823
DOIs	https://doi.org/10.1186/1472-6823-12-10
Publication status	Published - 22 Jun 2012

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Kristensen, P. L., Pedersen-Bjergaard, U., Beck-Nielsen, H., Nørgaard, K., Perrild, H., Christiansen, J. S., Jensen, T., Parving, H.-H., Thorsteinsson, B., & Tarnow, L. (2012). 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. B M C Endocrine Disorders, 12, 10. https://doi.org/10.1186/1472-6823-12-10

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. / Kristensen, Peter Lommer; Pedersen-Bjergaard, Ulrik; Beck-Nielsen, Henning et al.
In: B M C Endocrine Disorders, Vol. 12, 22.06.2012, p. 10.

Research output: Contribution to journal › Journal article › Research › peer-review

Kristensen, PL, Pedersen-Bjergaard, U, Beck-Nielsen, H, Nørgaard, K , Perrild, H, Christiansen, JS, Jensen, T, Parving, H-H, Thorsteinsson, B & Tarnow, L 2012, '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', B M C Endocrine Disorders, vol. 12, pp. 10. https://doi.org/10.1186/1472-6823-12-10

Kristensen PL, Pedersen-Bjergaard U, Beck-Nielsen H, Nørgaard K , Perrild H, Christiansen JS et al. 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. B M C Endocrine Disorders. 2012 Jun 22;12:10. doi: 10.1186/1472-6823-12-10

Kristensen, Peter Lommer ; Pedersen-Bjergaard, Ulrik ; Beck-Nielsen, Henning et al. / 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. In: B M C Endocrine Disorders. 2012 ; Vol. 12. pp. 10.

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T1 - 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)

T2 - study rationale and design

AU - Kristensen, Peter Lommer

AU - Pedersen-Bjergaard, Ulrik

AU - Beck-Nielsen, Henning

AU - Nørgaard, Kirsten

AU - Perrild, Hans

AU - Christiansen, Jens Sandahl

AU - Jensen, Tonny

AU - Parving, Hans-Henrik

AU - Thorsteinsson, Birger

AU - Tarnow, Lise

PY - 2012/6/22

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N2 - 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: NCT00346996.

AB - 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: NCT00346996.

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JO - B M C Endocrine Disorders

JF - B M C Endocrine Disorders

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