Date: 2015-12-01
Type of information: Presentation of results at a congress
phase:
Announcement: presentation of results at the 23rd World Diabetes Congress of the International Diabetes Federation (IDF)
Company: Novo Nordisk (Denmark)
Product: Ryzodeg®
Action
mechanism: insulin analog. Ryzodeg® is a combination of two distinct insulin analogues, insulin degludec and insulin aspart in the ratio of 70% and 30%. In a multinational trial, Ryzodeg® delivered twice daily at main meals offered a successful reduction in HbA1c 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 parameters. 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.
Disease: type 2 diabetes
Therapeutic area: Metabolic diseases
Country:
Trial details:
Latest
news: * On December 1, 2015, Novo Nordisk announced that new analyses demonstrate that Ryzodeg® (insulin degludec/insulin aspart) achieved successful glycaemic control with significantly lower rates of hypoglycaemia (low blood sugar) and nocturnal hypoglycaemia in patients with type 2 diabetes versus BIAsp 30 and/or a basal-bolus regimen of insulin degludec and insulin aspart. These findings were presented today at the 23rd World Diabetes * On September 18, 2014, Novo Nordisk announced that data presented 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 regimen. 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 aspart. 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% and 6.8% 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% and 20% 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%; p<0.05) versus the basalbolus regimen.
Congress of the International Diabetes Federation (IDF). The analyses of pooled data from five clinical studies highlighted that these benefits were delivered to patients irrespective of baseline HbA1c, disease duration or body mass index (BMI). The results also revealed that Ryzodeg® versus both comparators resulted in statistically significant reductions in fasting plasma glucose (FPG), and a lower insulin dose with significant differences in patients with BMI ?30 or a disease duration longer than 10 years.
These data are from the analyses of five 26-week treat-to-target phase 3a/b clinical trials in people with type 2 diabetes. The post-hoc pooled analyses evaluated the efficacy and safety of Ryzodeg® in controlling glycaemic parameters and rates of hypoglycaemia in patients with type 2 diabetes stratified according to baseline HbA1c, disease duration and body mass index (BMI). End of trial HbA1c, FPG, insulin dose and confirmed and nocturnal confirmed
CVR no: hypoglycaemia were analysed in the aforementioned patient categories, according to baseline characteristics stratification: HbA1c (<7.5%, ?7.5-<8.5%, ?8.5-<9.0%, ?9.0%), FPG (<5.5, >5.5-<7.0, >7.0-<10.0, >10.0 mmol/L), disease duration (?10 or >10 years) and BMI (?30 or >30 kg/m2)1-3.
