Abstract
BackgroundHypoglycaemia, especially nocturnal, remains the main limiting factor of achieving good glycaemic control in type 1 diabetes.The effect of first generation long-acting insulin analogues in reducing nocturnal hypoglycaemia is well documented in patient with type 1 diabetes. The effect of the newer long-acting insulin degludec on risk of nocturnal hypoglycaemia remains undocumented in patients with type 1 diabetes and recurrent severe nocturnal hypoglycaemia.The HypoDeg trial is designed to investigate whether insulin degludec in comparison with insulin glargine U100 is superior in limiting the occurrence of nocturnal hypoglycaemia in patients with recurrent nocturnal severe hypoglycaemia. This paper reports the study design of the HypoDeg trial.Methods/designA Danish investigator-initiated, prospective, randomised, open, blinded endpoint (PROBE), multicentre, two-year cross-over study investigating the effect of insulin degludec versus insulin glargine U100 on frequency of nocturnal hypoglycaemia in patients with type 1 diabetes and one or more episodes of nocturnal severe hypoglycaemia during the preceding two years as the major inclusion criteria. Patients are randomised (1:1) to basal therapy with insulin degludec or insulin glargine. Insulin aspart is used as bolus therapy in both treatment arms.DiscussionIn contrast to most other insulin studies the HypoDeg trial includes only patients at high risk of hypoglycaemia. The HypoDeg trial will compare treatment with insulin degludec to insulin glargine U100 in terms of risk of nocturnal hypoglycaemic episodes in patients with type 1 diabetes with the greatest potential to benefit from near-physiological insulin replacement therapy. www.clinicaltrials.gov: NCT02192450.
Highlights
Hypoglycaemia, especially nocturnal, remains the main limiting factor of achieving good glycaemic control in type 1 diabetes
The HypoDeg trial will compare treatment with insulin degludec to insulin glargine U100 in terms of risk of nocturnal hypoglycaemic episodes in patients with type 1 diabetes with the greatest potential to benefit from near-physiological insulin replacement therapy. www.clinicaltrials.gov: NCT02192450
The first-generation insulin analogues insulin glargine U100 and insulin detemir both reduce nocturnal hypoglycaemia by 26–53% compared to Neutral protamine Hagedorn (NPH) insulin [2,3,4]
Summary
In contrast to almost all other studies in this field the HypoDeg trial includes only patients who are hypoglycaemia-prone. The HypoDeg trial will elucidate whether once-daily insulin degludec in comparison with once-daily insulin glargine U100 during basal-bolus therapy is advantageous in limiting the number of hypoglycaemic episodes in these patients who may have the greatest benefit from optimized basal insulin therapy. This insulin trial is one of a few to systematically evaluate the risk of hypoglycaemia by simultaneous adjudication of events, reporting in diaries and observation by CGM [5,6,7].
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