Abstract
BackgroundSevere 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/designThe 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.DiscussionIn 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.
Highlights
Severe hypoglycaemia still represents a significant problem in insulin-treated diabetes
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. www.clinicaltrials.gov: NCT00346996
The analysis showed that the overall mean occurrence of hypoglycaemic episodes was lower for short-acting analogues in comparison to regular insulin in patients with type 1 diabetes (−0.2 per patient per month (95% confidence interval: -1.1 to 0.7))
Summary
In contrast to almost all other studies in this field the HypoAna Trial includes only patients with major hypoglycaemic problems. The HypoAna Trial will elucidate whether short-acting and long-acting insulin analogues in comparison with human insulin are advantageous. Authors’ contributions PLK, UP-B, HB-N, KN, HP, JSC, TJ, H-HP, BT and LT conceived the study, and participated in its design and coordination. PLK, UP-B, BT and LT drafted the manuscript. All authors have read and approved the final manuscript
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