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United States : Faster-acting insulin aspart showed a statistically significant reduction in HbA1c in type 1 diabetes and a comparable HbA1c reduction in type 2 diabetes versus NovoLog (insulin aspart rDNA origin injection).

New phase 3a findings showed that faster-acting insulin aspart demonstrated a statistically significant reduction in HbA1c in type 1 diabetes, compared with NovoLog (insulin aspart rDNA origin injection),1 a comparable HbA1c reduction in type 2 diabetes versus NovoLog2 and improved post-meal or postprandial glucose (PPG) control in type 1 and type 2 diabetes.1,2 Results from the onset 1 and onset 2 treat-to-target trials comparing faster-acting insulin aspart with NovoLog were presented at the 76th annual Scientific Sessions of the American Diabetes Association (ADA) in New Orleans, U.S.

In onset 1, after 26 weeks of randomised therapy, faster-acting insulin aspart showed statistically significantly greater HbA1c reduction versus NovoLog 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 NovoLog 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 increment1 ( 95% CI -0.67 -1.29; -0.04 mmol/L) versus NovoLog. 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 NovoLog ( 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 increment2 ( 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 NovoLog.1,2

Other common adverse events (?5%) included nasopharyngitis, upper respiratory tract infection, urinary tract infection, headache, nausea, diarrhoea, wrong drug administration and back pain.

Also presented during the scientific meeting were additional trial results assessing the pharmacokinetic (PK) and pharmacodynamic (PD) properties of faster-acting insulin aspart versus NovoLog:

Results from a pooled analysis evaluating early exposure and glucose-lowering effect of faster-acting insulin aspart versus NovoLog in people with type 1 diabetes (Abstract 929-P).

Results from a clinical study evaluating the early glucose-lowering effect with faster-acting insulin aspart (Abstract 969-P).

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Publication:Mena Report
Date:Jun 18, 2016
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