Evaluating a novel insulin for type 1 diabetes

The authors compared the effectiveness of two long-acting insulins; insulin degludec (Tresiba) and insulin detemir (Levemir).

Basal-bolus insulin therapy in type 1 diabetes involves the use of a long-acting insulin dose (basal) to keep blood glucose levels stable through periods of fasting and a short-acting insulin dose (bolus) to prevent rises in blood glucose levels resulting from meals. 

The aim of this trial was to compare the effectiveness of the novel long-acting insulin degludec with insulin detemir given as the long-acting (basal) insulin, administered alongside short-acting (bolus) insulin aspart (NovoRapid).  

456 subjects with type 1 diabetes were randomly assigned to receive either insulin degludec (303 patients) or insulin detemir (153 patients) once-daily over 26 weeks. All patients also received of mealtime insulin aspart. At baseline, participants had an average HbA1c level (a measurement of average blood glucose levels over the past 3 months) of 8% and an average duration of diabetes of 13.9 years.

The average reduction in HbA1c levels by the end of the study was 0.73% for insulin degludec and 0.65% for insulin detemir. By the end of the study, fasting plasma glucose (level of blood glucose after several hours without food) decreased by 2.6 mmol/l with insulin degludec and 0.62 mmol/l with insulin detemir.

The overall rate of severe hypoglycaemia was 0.31 episodes per year for patients treated with insulin degludec and 0.39 episodes per year for patients treated insulin detemir. Insulin degludec was associated with a significant 34% lower rate of night-time hypoglycaemia compared to insulin detemir.

Body weight increased by an average of 1.5 kg with insulin degludec and 0.4 kg with insulin detemir. 73% of patients taking insulin degludec experienced adverse events compared to 74% of those taking insulin detemir, and more than 90% of these were mild or moderate.

The authors concluded that insulin degludec administered once-daily as part of a basal-bolus therapy effectively improves long-term blood glucose control in patients with type 1 diabetes and is associated with a significantly lower risk of night-time hypoglycaemia and larger reduction in fasting plasma glucose than insulin detemir.

The investigators were aware of the drug they were administering, and therefore may have been more cautious when titrating and administering dosing of the novel insulin degludec.