Basal insulin analogues in type 1 diabetes – Does one size fit all? Lessons from the HypoDeg trial based on single-patient outcomes

Abstract

Aims: In the HypoDeg trial, a randomised crossover trial in people with type 1 diabetes prone to nocturnal severe hypoglycaemia, treatment with insulin degludec (IDeg) resulted in significantly reduced rates of nocturnal symptomatic hypoglycaemia and all-day severe hypoglycaemia compared to insulin glargine U100 (IGlar). We analysed HypoDeg data at a single-patient level to assess the proportion of participants to whom the overall result applied. Methods: Post hoc analysis using single-patient data (n = 133) on nocturnal symptomatic hypoglycaemia, all-day severe hypoglycaemia and HbA1c. The outcome was classified as superior with IDeg, superior with IGlar, or similar between treatments for the three outcomes. We also assessed a composite endpoint based on these outcomes to evaluate the overall superior treatment for each participant. Results: A higher percentage (38 %) had IDeg as superior treatment compared to IGlar (15 %) for nocturnal symptomatic hypoglycaemia (p < 0.001). There was no difference between the treatments for all-day severe hypoglycaemia or HbA1c. A higher percentage (44 %) had a composite endpoint favouring IDeg compared to IGlar (16 %) (p < 0.001). Conclusions: The superiority of IDeg was confirmed in many of the participants. However, a minority had IGlar as superior treatment, underscoring the need for individualised basal insulin therapy in clinical practice.

Keywords

• Type 1 diabetes
• Individualised therapy
• Hypoglycaemia
• Insulin analogues
• Insulin degludec
• Insulin glargine U100