(Updates with details of study, background)
By Nikolaj Skydsgaard
COPENHAGEN Nov 29 Novo Nordisk's
long-acting insulin blockbuster Tresiba has a safe
cardiovascular profile and reduces episodes of severely low
blood glucose levels in patients with type 2 diabetes, the
Denmark-based company said on Tuesday.
Type 2 diabetics who need insulin to control their blood
sugar risk having too low levels of glucose in their blood,
which can cause tiredness, confusion and in some cases
The so-called DEVOTE study, involving more than 7,500
patients, demonstrated Tresiba's non-inferiority of major
adverse cardiovascular events to rival Sanofi's
long-acting insulin Lantus (insulin glargine), Novo said.
Interim data from DEVOTE ensured the U.S. Food & Drug
Administration's (FDA) approval of Tresiba in September 2015, so
either neutral or positive results were to be expected from
However, data from the study has been kept under wraps until
now in order not to impact the remaining study results.
Tresiba, a once-daily basal insulin which keeps a diabetic's
blood glucose levels stable between meals and during sleep, also
showed a statistically significant 40 percent overall reduction
of severe hypoglycaemia in patients.
Patients treated with Tresiba also experienced a 54 percent
lower rate of nocturnal hypoglycaemia.
Novo Nordisk faces tough price pressure in its biggest
market, the U.S., and slashed its long-term growth guidance in
its October earnings, causing shares to plummet.
The company also axed 1,000 jobs and announced the
discontinuation of several pipeline projects, including what is
commonly referred to as the holy grail among diabetes drugs,
insulin in a pill form.
Novo has already applied for a label description update for
Tresiba in both the EU and the U.S. after trials earlier this
year showed therapy with Tresiba led to fewer episodes of low
blood sugar levels (hypoglycaemia) compared to therapy with
Novo expects to submit findings from the DEVOTE study for
review with regulatory authorities during first half of 2017.
(Editing by David Evans and Alexander Smith)