Data presented recently at the 50th Annual Meeting of the European Association for the Study of Diabetes (EASD) show that Ryzodeg (insulin degludec/insulin aspart) administered twice daily, provides successful glycaemic control with fewer injections than a basal-bolus regimen1 .
Ryzodeg is a combination of two distinct insulin analogues (insulin degludec and insulin aspart in the ratio of 70 per cent and 30 per cent), making it the first combination of a basal insulin with an ultra-long duration of action and a well-established mealtime insulin in one pen for people with type 2 diabetes.
"Patients currently using basal-bolus regimens may need to take up to four daily injections, which can be a great burden and very inconvenient. Ryzodeg is a new treatment option which provides proven glycaemic control, with fewer injections and reduced rates of hypoglycaemia compared to basal-bolus regimens," said Dr Helena Rodbard, the study's principal investigator and endocrinologist in Rockville, MD, USA. "This new treatment offers the potential for a simple alternative to basal-bolus for patients who require intensification of basal insulin regimens," she added.
The study presented at EASD was a 26-week randomised multinational phase 3b trial, where patients previously treated with basal insulin were randomised to a regimen of either twice daily Ryzodeg, or a basal-bolus regimen of once-daily insulin degludec plus two to four injections of insulin aspart1. The study did not meet its primary endpoint of non-inferiority; however, the results showed that HbA1c was reduced for patients on either regimen, to 7.0 per cent and 6.8 per cent respectively, with no significant difference between the two regimens1. Patients who received Ryzodeg experienced a numerically lower rate of overall and nocturnal confirmed hypoglycaemic episodes1, 19 per cent and 20 per cent less, respectively. They also gained significantly less weight (p<0.05) over the course of the study and used a significantly lower daily insulin dose1 (12 per cent; p<0.05) versus the basal-bolus regimen.
Type 2 diabetes is a progressive disease5, which means some patients will need to intensify insulin treatment eventually by adding mealtime insulin bolus therapy to achieve or maintain their glycaemic targets over time5. Studies have shown that more than 50 per cent of people with type 2 diabetes on basal insulin alone are not achieving their glycaemic targets as measured by HbA1c6-8. Complications from diabetes caused by failing to keep optimal glycaemic control can be serious and may include problems such as heart disease, stroke, blindness, kidney disease, nerve damage and premature mortality.
Ryzodeg is a combination of two distinct insulin analogues, insulin degludec and insulin aspart in the ratio of 70 per cent and 30 per cent. In a multinational trial, Ryzodeg delivered twice daily at main meals offered a successful reduction in HbA1c2,4 with lower risk of hypoglycaemia versus biphasic insulin aspart 30 in people with type 2 diabetes4. In other studies no apparent differences were shown between Ryzodeg and its comparators, with respect to adverse events and standard safety parameters4,11-13. Ryzodeg has been approved in Aruba, Brazil, Chile, Costa Rica, El Salvador, the EU, Hong Kong, Iceland, India, Israel, Japan, Kazakhstan, Macedonia, Mexico, Norway, Russia, South Korea and Switzerland.
The clinical trial programmes for insulin degludec (BEGIN) and Ryzodeg (BOOST) comprise the largest in the field of insulin therapy, with more than 11,000 people included. Novo Nordisk completed the phase 3a BOOST programme in 2010. This programme consisted of six randomised, controlled, treat-to-target trials in more than 30 countries. More than 2,000 people were included in the development programme. The programme was designed after consultancy with regulatory agencies in Europe, Japan and USA.