A review of the latest clinical trial data from the American Diabetes Association's 76th Scientific Sessions in New Orleans, USA.
New results from two phase 3b trials have shown that type 1 and type 2 diabetes patients treated with insulin degludec (Tresiba) experience significantly lower rates of several types of hypoglycaemia, compared with patients treated with insulin glargine U100.
The findings are important for people with diabetes, as fear of hypoglycaemia or 'hypos' is a common problem and a feeling that is often shared by their friends and loved ones. On average, people with type 1 diabetes experience two episodes of symptomatic hypoglycaemia per week and for people with type 2 diabetes, at least one episode per fortnight, with almost 50% of all types of hypos occurring during the night. Hypos range from mild to severe and can greatly impact quality of life, affecting people's sleep patterns, their relationships and their ability to work.
The results from the SWITCH, treat to target, trials—the first-ever double-blinded, crossover basal insulin studies—assessing the safety and efficacy of insulin degludec compared to insulin glargine U100 in patients at high risk of hypoglycaemia with type 1 diabetes (SWITCH 1) and type 2 diabetes (SWITCH 2), were presented at the ADA conference.
In SWITCH 1, type 1 diabetes patients on insulin degludec showed:
- Significantly lower rates of severe or blood-glucose confirmed symptomatic hypoglycaemia versus insulin glargine U100 in the maintenance period
- Significantly lower number of severe of bloodglucose confirmed symptomatic nocturnal hypoglycaemia (occurring between the hours of 00:01–05:59) in the maintenance period
- Significantly reduced rate of severe hypoglycaemia in the maintenance period and across total treatment period
- Superiority to insulin glargine U100 regarding a lower proportion of patients experiencing severe hypoglycaemia during maintenance and total treatment periods
- HbA1c non-inferiority of insulin degludec versus insulin glargine U100 at week 32 (6.95 versus 6.92%) and week 64 (6.95 versus 6.97%).
In SWITCH 2, type 2 diabetes patients on insulin degludec showed:
- Significantly lower rates of severe or blood-glucose confirmed symptomatic hypoglycaemia during the maintenance period
- Significantly lower number of severe or bloodglucose confirmed symptomatic nocturnal hypoglycaemia (occurring between the hours of 00:01–05:59) versus insulin glargine U100, during the maintenance period
- Similar rates of severe hypoglycaemia during the maintenance period versus insulin glargine U100 (significantly lower in the full treatment period)
- HbA1c non-inferiority of insulin degludec versus insulin glargine U100.
Dr Simon Heller, Professor of Clinical Diabetes at Sheffield University, said: "Hypoglycaemia is a common concern for patients I see treated with insulin, particularly night-time episodes that are harder to detect and manage. The SWITCH results add important new evidence to the overall body of data supporting the use of insulin degludec for people living with type 1 or type 2 diabetes who experience problematic hypoglycaemia - and provide additional clinical approaches in this important group of patients."