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Novo Nordisk have presented phase 2 proof-of-concept data for its investigational insulin degludec, an ultra-long-acting basal insulin, which demonstrated the potential to help achieve target glycaemic control when used once-daily or three-times-weekly. These data were presented at the 70th Scientific Sessions of the American Diabetes Association (ADA).
Insulin degludec is a novel insulin molecule with a new mode of action that provides a smooth and stable profile. Insulin degludec has a distinct ultra-long clinical profile derived from its specially engineered molecular structure that is designed to self-assemble into large soluble formations at the site of injection. The formations, known as multi-hexamer formations, are believed to slow the absorption rate of the insulin into the blood which leads to a longer profile of action and the possibility of a three-times-weekly dosing regimen in patients with type 2 diabetes.
In these phase 2 studies insulin degludec formulations demonstrated glycaemic control similar to insulin glargine. In one study, after 16 weeks of treatment with insulin degludec, mean HbA1c reductions were similar across the once-daily and three-times-weekly insulin degludec groups (-1.3% and -1.5% respectively) and comparable to insulin glargine (-1.5%).
In this study, a similar rate of hypoglycaemia was observed in patients treated with insulin degludec three-times-weekly and insulin glargine once-daily. The rate of hypoglycaemia appeared lower for insulin degludec once-daily than insulin degludec three-times-weekly and insulin glargine (0.6, 2.3, 1.1 events/patient yr, respectively; p=NS for both comparisons).
The proportion of patients with adverse events (AEs) was similar across treatment arms (insulin degludec once-daily: 47%; insulin degludec three-times-weekly: 50%; insulin glargine: 66%) with no specific patterns or clustering. The majority of AEs were mild or moderate in severity.
“Insulin degludec has shown the potential to help deliver improvements in glycaemic control with less than one daily injection” said Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo Nordisk.
“The low rate of hypoglycaemia after once-daily insulin degludec administration, as well as the potential to be used three times weekly in people with type 2 diabetes will be further evaluated in our pivotal phase 3 trials in the BEGIN and BOOST programmes”.
Insulin degludec/insulin aspart (IDegAsp), a combination-insulin with insulin degludec and insulin aspart, is being tested in the BOOST programme. It is being studied for its ability to provide the ultra-long-acting basal coverage of insulin degludec as well as a bolus boost to cover the meal coinciding with the injection. Phase 2 data presented at ADA showed that IDegAsp once daily brought the majority of patients to ADA-recommended glycaemic targets (<7% HbA1c) without confirmed major hypoglycaemia after 16 weeks of treatment. In this proof-of-concept trial, there were 60 patients taking insulin glargine and 59 on IDegAsp with comparable glycaemic control.
Diabetes affects more than 285 million people worldwide and requires lifelong treatment. In the UK there are nearly 3 million people diagnosed with type 2 diabetes. Some patients can find diabetes treatment regimens difficult to adhere to, which can reduce compliance to treatment and lead to poor glycaemic control. Novo Nordisk is committed to developing innovative solutions to help healthcare professionals and patients effectively manage this disease.
Novo Nordisk is exploring the clinical profile of insulin degludec and IDegAsp in one of the largest ever phase 3a clinical trial programmes in the field of insulin therapy, BEGIN and BOOST, with more than 10,000 patients.