GHP July 2016

ghp July 2016 | 55 Research & Development Results from the onset 1 and onset 2 treat-to-target trials comparing faster-acting insulin aspart with NovoRapid ® were presented at the 76th annual Scientific Sessions of the American Diabetes Association (ADA) in New Orleans, US. In onset 1, after 26 weeks of randomised therapy, faster-acting insulin aspart showed statistically significantly greater HbA1c reduction versus NovoRapid ® in adults with type 1 diabetes when dosed at mealtime ([95% confidence interval (CI)] -0.15 [-0.23; -0.07]). Faster-acting insulin aspart also showed comparable HbA1c reduction when dosed 20 minutes after starting a meal, compared with NovoRapid ® dosed at mealtime ([95% CI] 0.04 [-0.04; 0.12])1. Trial results for onset 1 also showed superior reduction in 2-hour PPG increment* ([95% CI] -0.67 [-1.29; -0.04] mmol/L) versus NovoRapid ® . The change in 1-hour PPG increment*, a secondary supportive endpoint, was also reduced ([95% CI] -1.18 [-1.65; -0.71] mmol/L)1. In onset 2, faster-acting insulin aspart demonstrated non-inferiority in HbA1c reduction compared with NovoRapid ® ([95% CI] -0.02 [-0.15; 0.10]) in adults with type 2 diabetes. Trial results could not confirm a statistically significant reduction in 2-hour PPG increment* ([95% CI] -0.36 [-0.81; 0.08] mmol/L). However, a statistically significant reduction in 1-hour PPG increment* was shown with faster-acting insulin aspart ([95% CI] -0.59 [-1.09; -0.09] mmol/L)2 which was a secondary supportive endpoint. “We know that many people living with type 1 or type 2 diabetes may frequently struggle with spikes in blood glucose around mealtimes, resulting in post- meal hyperglycaemia,” said Dr Bruce Bode, onset 1 and onset 2 investigator, Diabetes Specialist and Clinical Associate Professor of Medicine at Emory University School of Medicine, Atlanta, US. “The improvements in HbA1c and postprandial glucose control we see with faster-acting insulin aspart in the data from the onset 1 and onset 2 trials are encouraging.” The most commonly reported adverse event with faster-acting insulin aspart in onset 1 and 2 was hypoglycaemia. However, there were no significant differences in the overall rate of severe or confirmed hypoglycaemia in people with type 1 and type 2 diabetes compared with NovoRapid ® 1,2. Other common adverse events ( ≥ 5%) included nasopharyngitis, upper respiratory tract infection, urinary tract infection, headache, nausea, diarrhoea, wrong drug administration and back pain3,4. Also presented during the scientific meeting were additional trial results assessing the pharmacokinetic (PK) and pharmacodynamic (PD) properties of faster- acting insulin aspart versus NovoRapid ® : • Results from a pooled analysis evaluating early exposure and glucose-lowering effect of faster-acting insulin aspart versus NovoRapid ® in people with type 1 diabetes (Abstract 929-P)5; • Results from a clinical study evaluating the early glucose-lowering effect with faster-acting insulin aspart (Abstract 969-P)6. About the Onset 1 and 2 Trials The onset programme is a phase 3 clinical programme with faster-acting insulin aspart that consists of four trials encompassing more than 2,100 people with type 1 and type 2 diabetes. The onset 1 trial (1,143 people randomised): a 26+26-week randomised, partially double-blind, basal-bolus, treat-to-target trial investigating faster- acting insulin aspart dosed at mealtime or 20 minutes after starting a meal compared with NovoRapid ® dosed at mealtime, both in combination with a basal insulin in adults with type 1 diabetes. Only the data from the first 26 weeks were reported at the 76th annual Scientific Sessions of the ADA. The primary endpoint was change from baseline HbA1c versus NovoRapid®, and a secondary endpoint was change from baseline in 2-hour PPG increment* versus NovoRapid ® . The onset 2 trial (689 people randomised): a 26-week randomised, double-blind, basal-bolus, treat-to-target trial investigating faster-acting insulin aspart compared with NovoRapid ® , both dosed at mealtime and in combination with a basal insulin and metformin in adults with type 2 diabetes. The primary endpoint was change from baseline HbA1c versus NovoRapid ® , and a secondary endpoint was change from baseline in 2-hour PPG increment* versus NovoRapid ® . For further information, please visit: www.novonordisk.com New phase 3a findings showed that faster-acting insulin aspart demonstrated a statistically significant reduction in HbA1c in type 1 diabetes, compared with NovoRapid ® (insulin aspart) 1, a comparable HbA1c reduction in type 2 diabetes versus NovoRapid ® 2 and improved post-meal or postprandial glucose (PPG) control in type 1 and type 2 diabetes1,2.