--Sanofi says data strengthen efficacy profile of Lantus in
early treatment
--Lantus, however, is tied to more low-blood-sugar episodes than
Januvia
--Amylin's Byetta is superior to older diabetes drug in separate
study
By Peter Loftus
Sanofi's (SNY) Lantus insulin reduced blood-sugar levels to a
greater degree than did Merck & Co.'s (MRK) Januvia in people
with Type 2 diabetes in a clinical trial, researchers said
Saturday.
A separate study in a similar patient population concluded that
Amylin Pharmaceuticals Inc.'s (AMLN) Byetta was superior to an
older drug in controlling the disease.
Sanofi said the results from the Lantus study strengthen the
efficacy profile of the drug when introduced early in the course of
treatment for diabetes.
However, Lantus was associated with higher rates of low
blood-sugar episodes and weight gain compared with Januvia. And
given that many patients and doctors prefer to delay the start of
insulin treatment, the results may not put a huge dent in Januvia's
appeal.
Merck spokeswoman Kelly Dougherty said Januvia provides
significant reductions in a measure of blood sugar and, when used
by itself, generally isn't associated with excessively low blood
sugar or weight gain.
Lantus is a long-acting form of artificial insulin--known as
insulin glargine--that is injected once a day. It is Sanofi's
top-selling product, with EUR3.92 billion in sales for 2011.
Merck's Januvia is a pill orally administered once daily; it is
part of a newer class of drugs known as DPP-4 inhibitors. Januvia
had 2011 sales of $3.3 billion and has been one of Merck's
fastest-growing products.
Type 2 diabetes is the most common form of diabetes, and is a
chronic disease involving high blood-sugar levels. Many patients
start drug therapy with an older treatment, metformin. If metformin
alone eventually fails to control blood sugar adequately, other
treatments may be added including Januvia, other oral agents or
injectables.
Lantus and other forms of insulin are commonly introduced later
in the course of the disease, after other options fail to
adequately control blood sugar. But Lantus is also an alternative
to Januvia as a second-line therapy after metformin.
A Sanofi-funded clinical trial set out to compare Lantus
head-to-head against Januvia in this second-line setting. About 515
patients with Type 2 diabetes were randomly assigned to receive
either Lantus or Januvia, in addition to metformin in both groups,
for 24 weeks. Researchers tracked the change in a measure of blood
sugar known as HbA1c through the end of treatment.
The average reduction in HbA1c for Lantus users was 1.7%,
compared with 1.1% in Januvia users, according to results released
Saturday at the annual scientific meeting of the American Diabetes
Association in Philadelphia. The data were published online
simultaneously by the Lancet, a medical journal.
Lantus patients also were more likely to achieve recommended
HbA1c levels than were Januvia users, according to researchers.
However, the average rate of episodes of hypoglycemia, or low
blood sugar, was higher among Lantus users than Januvia patients.
Some 46% of Lantus users had at least one hypoglycemic event,
versus 13% of Januvia users. Low blood sugar can cause fainting or
seizures.
Lantus also was associated with weight gain, while Januvia was
linked to weight loss. The researchers, however, said rates of
severe hypoglycemia were low in Lantus users, and weight gain was
mild.
An accompanying commentary in the Lancet said longer studies are
needed to assess the long-term effects of both Januvia and Lantus
when introduced after metformin in the course of treatment. Studies
also should track additional measures such as effects on blood
pressure and cholesterol levels, the commentary said.
In a separate study released at the ADA meeting and published by
the Lancet, Amylin's Byetta reduced the rate of treatment failure
compared with an older drug in a clinical trial of people with Type
2 diabetes.
Byetta is a non-insulin, injectable treatment for diabetes, in a
class known as GLP-1 receptor agonists. It is also an option to add
to metformin after metformin fails to adequately control blood
sugar.
In a study funded by Amylin and its one-time partner for Byetta,
Eli Lilly & Co. (LLY), some patients were given Byetta twice
daily and others were given glimepiride, an older drug, once daily.
Both were added to metformin.
Researchers tracked how many patients in each group had
deterioration of blood-sugar control to the point they needed an
alternative treatment.
Some 41% of Byetta users had treatment failure, versus 54% of
glimepiride patients.
Measured another way, some 44% of Byetta patients achieved an
HbA1c concentration of less than 7%, versus 31% of the glimepiride
users.
Byetta was associated with a decrease in body weight versus
glimepiride. The overall rates of serious adverse events were
comparable between the drugs; Byetta was associated with higher
rates of certain gastrointestinal symptoms.
Christian Weyer, senior vice president of research and
development at Amylin, said the results support Byetta as an option
for patients whose diabetes isn't controlled by metformin
alone.
The study was started when Lilly and Amylin had an alliance to
co-develop and co-market Byetta and a newer drug, Bydureon.
However, the companies disclosed last year they would terminate the
alliance in a transition through the end of 2013.
Write to Peter Loftus at peter.loftus@dowjones.com.