Novo Nordisk has presented promising mid-stage data on its investigational insulin degludec, which when taken three times a week, was as effective as Sanofi-Aventis’ big-selling once-daily treatment Lantus, potentially a real boon for diabetics.
Phase II data, presented at the American Diabetes Association meeting in Orlando, Florida, showed that in one study, after 16 weeks of treatment, 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 Sanofi’s Lantus (insulin glargine). Some 77% of patients treated with degludec three times weekly did not experience any confirmed hypoglycaemia, similar in the study arm using Lantus once-daily.
Mads Krogsgaard Thomsen, chief science officer at Novo, said 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 Phase III trials.
The Danish drugmaker also noted that a combination-insulin with degludec and aspart, “is being tested in one of the largest ever Phase IIIa clinical trial programmes in the field of insulin therapy”. The BEGIN and BOOST trials will involve more than 10,000 patients.
The Bagsvaerd, Copenhagen-headquartered firm also presented late-breaking data at the ADA which showed that the once-daily glucagon-like peptide-1 analogue Victoza (liraglutide), in combination with metformin, produced sustained and significantly greater reductions in A1c, body weight and fasting plasma glucose than Merck & Co’s dipeptidyl peptidase-4 inhibitor Januvia (sitagliptin) plus metformin at 52 weeks.
Specifically, patients treated with 1.2mg and 1.8mg of Victoza experienced greater reductions in A1c than those treated with Januvia 100mg (-1.3% and -1.5% versus -0.9%). The Novo drug provided greater weight loss (2.8 kg and 3.7 kg for 1.2mg and 1.8mg respectively) compared with 1.2kg for the Merck treatment.
The company quoted Richard Pratley of the University of Vermont College of Medicine as saying that although Victoza is not indicated for the management of obesity, providing greater weight loss than Januvia “is a benefit for those patients with type 2 diabetes struggling to maintain a healthy weight.”
