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Rivals look to put pressure on Sanofi's Lantus

Novo Nordisk and Lilly claim clinical benefitsover top-selling diabetes drug

ADA conference 

The American Diabetes Association's (ADA) Scientific Sessions meeting in Boston this weekend saw several of Sanofi's rivals claim clinical benefits over its blockbuster Lantus (insulin glargine).

Currently the world's best-selling diabetes drug, Lantus faces increasing pressure from competitors - and an impending biosimilar threat - as Sanofi looks to transition to a longer-acting version of the insulin called Toujeo.

One of those with Lantus in its sights is Novo Nordisk, whose Xultophy combination of Tresiba (insulin degludec) and Victoza (liraglutide) was pitted against Lantus in the DUAL V study.

The trial found a significant reduction in HbA1C levels of an average of 1.8% - compared with 1.1% in the Lantus group, and a weight decrease of 1.4kg - compared with an increase of 1.8kg for patients on Lantus.

The phase IIIb trial ran for 26 weeks and was a treat-to-target, randomised, open-label study of 557 patients and compared the efficacy and safety of Xultophy against an 'intensification' of treatment with Lantus, when both were added to metformin.

It saw adults, whose type 2 diabetes was uncontrolled on 20-50 units of Lantus, titrated up to 50 units of Tresiba and 1.8mg of Victoza, with no maximum daily dose of Lantus.

Meanwhile, Lilly unveiled a head-to-head study of Sanofi's long-acting insulin and Lilly's once-weekly GLP-1 agonist Trulicity (dulaglutide), which was approved in the US last year.

The type 2 diabetes study involved nearly 800 East Asian patients mainly from China, but with Korea, Mexico and Russia also represented.

It found A1C reductions in patients on 1.5mg and 0.75mg of Trulicity of 1.7% and 1.32% respectively, compared to a 1.15% reduction in the Lantus group. 

The company also released the results of five phase III studies of its long-acting insulin peglispro, which had a serious setback earlier this year when liver fat changes seen in trials caused Lilly to delay regulatory filings of the drug in the US and Europe.

Three of the peglispro trials presented were in type 2 diabetes and the company said the IMAGINE 2, 4 and 5 studies found greater HbA1c benefits, and saw a higher proportion of patients reaching the ADA's target of HbA1c of less than 7%.

However, patients on the drug had an increase in the liver enzyme ALT and higher triglyceride levels than patient treated with Lantus.

A further two IMAGINE studies (1 and 3) covered type 1 diabetes and showed more peglispro patients reached HbA1c target levels than those on Lantus (45% to 28% in IMAGINE 1 and 35% to 26% in IMAGINE 3).

However, some of the IMAGINE trials showed an increase in the liver enzyme ALT and higher levels of liver fat for patients on peglispro, compared to those on Lantus.

Article by
Dominic Tyer

8th June 2015

From: Research



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