Data presented at the World Diabetes Congress of the International Diabetes Federation (IDF) show that adults with type 2 diabetes achieved improved glycaemic control, significantly lower rates of overall and nocturnal confirmed hypoglycaemia for the full trial period, and a significantly lower rate of severe hypoglycaemia during the maintenance period (defined as week 16 onwards) with Ryzodeg® compared to biphasic insulin aspart 30, both administered twice-daily.(1)
Ryzodeg® is the first combination of two distinct insulin analogues, Tresiba® (insulin degludec), the once-daily basal insulin with an ultra-long duration of action, and the well-established mealtime insulin NovoRapid® (insulin aspart), in the ratio of 70% and 30%, in one pen for people with type 2 diabetes.(2-4)
“Type 2 diabetes is a progressive disease and many patients who are uncontrolled with basal insulin need to add mealtime insulin to achieve or maintain their glycaemic targets over time. As Ryzodeg® is a combination of two distinct insulins, a basal insulin with a long and steady action profile and a well-established mealtime insulin, it is a simple way for patients to add mealtime control with a reduced risk of overall and nocturnal confirmed, and severe hypoglycaemia,” said lead investigator Gregory Fulcher, Royal North Shore Hospital, Sydney, Australia.
The multinational BOOST™ INTENSIFY PREMIX I trial was a 26-week, randomised, controlled open-label, treat-to-target trial comparing the efficacy and safety of Ryzodeg® and biphasic insulin aspart 30, both administered twice-daily with or without oral antidiabetic drugs in adult patients with type 2 diabetes previously treated with premixed or self-mixed insulin either once- or twice-daily.
Overall study results include(1):
- Ryzodeg® achieved the primary endpoint of non‐inferiority to biphasic insulin aspart 30 for mean change in HbA1c from baseline (estimated treatment difference [ETD] –0.03% points, 95% CI –0.18; 0.13).
- Ryzodeg® achieved the secondary endpoint of superiority in lowering FPG compared with biphasic insulin aspart 30 (ETD –1.14 mmol/L, 95% CI –1.53; –0.76, p<0.001).
- Final mean daily insulin dose was 11% lower for Ryzodeg® compared with biphasic insulin aspart 30 (1.08 U/kg versus 1.20 U/kg; estimated rate ratio [RR] 0.89, 95% CI 0.83; 0.96, p=0.002).
- Significantly lower rates of overall confirmed (self-reported PG <3.1 mmol/L or severe episode requiring assistance) and nocturnal confirmed hypoglycaemia (onset 00.01–05.59 hours) for Ryzodeg® versus biphasic insulin aspart 30 were reported.
– A 32% lower rate of overall confirmed hypoglycaemia (9.7 versus 14.0 episodes/patient/year, RR 0.68, 95%CI 0.52; 0.89, p=0.0049).
– A 73% lower rate of nocturnal confirmed hypoglycaemia (0.7 versus 2.5 episodes/patient/year; RR 0.27, 95% CI 0.18; 0.41, p<0.0001).
– A numerically lower rate of severe hypoglycaemia, although the difference was not significant (0.09 versus 0.25 episodes/patient/year, RR 0.50, 95% CI 0.19; 1.30, p=ns).
- During the maintenance period (defined as week 16 onwards, a period when majority of patients achieve stable insulin dose and glycaemic control) significant differences were reported in rates of hypoglycaemia comparing Ryzodeg® with biphasic insulin aspart 30.
– A 39% lower rate of overall confirmed hypoglycaemia (RR 0.61, 95% CI 0.45; 0.83, p=0.0015).
– A 77% lower rate of nocturnal confirmed hypoglycaemia (RR 0.23, 95% CI 0.13; 0.41, p<0.0001).
– An 89% lower rate of severe hypoglycaemia (RR 0.11, 95% CI 0.01; 0.91, p=0.04).
- Fulcher G, et al. Insulin degludec/insulin aspart achieves superior FPG and less hypoglycaemia vs biphasic insulin aspart 30 in poorly controlled T2DM. Poster #1399, presented at International Diabetes Federation (IDF), World Diabetes Congress, Melbourne, December 2013.
- Ryzodeg® Summary of Product Characteristics (SmPC). May 2013.
- Jonassen I, et al. Ultra-long acting insulin degludec can be combined with rapid-acting insulin aspart in a soluble co-formulation. J Peptide Sci 2010;16(Suppl.1):32.
- De Rycke A, et al. Degludec – first of a new generation of insulins. Eur Endocrinol 2011;7:84-7.