| June 22
June 22 A once-weekly drug for type 2 diabetes
developed by Eli Lilly and Co worked better at
controlling blood sugar than three other widely used medicines,
according to data from late- stage clinical trials.
The data, presented on Saturday at the American Diabetes
Association (ADA) meeting in Chicago, also showed that the Lilly
shot helped patients lose twice as much weight as those taking
Merck & Co's $4 billion-a-year drug, Januvia.
The findings from the trio of late-stage studies suggest the
treatment known as dulaglutide could be an important new weapon
in the fight against type 2 diabetes, whose rapid growth
globally has become a crisis affecting more than 300 million
"This is a very promising, safe and efficacious agent for
the treatment of diabetes," Dr Guillermo Umpierrez, one of the
lead investigators of the dulaglutide Phase III trial program,
said in an interview.
Diabetes is a disease in which the body does not produce
enough insulin to control levels of blood sugar. It can lead to
many serious health complications including heart problems,
kidney disease and vision loss.
The results of the new studies showed that an injection of
dulaglutide led to sustained reductions in blood sugar and
helped more patients reach recommended target levels than those
taking generic metformin, Byetta, a drug from Bristol-Myers
Squibb Co, and Januvia, the studies showed. There were
no reported cases of serious hypoglycemia, or dangerously low
Lilly plans to use data from the three trials as a major
part of the application seeking U.S. approval for dulaglutide it
expects to file later this year.
If approved, dulaglutide would become a direct rival of
once-weekly Bydureon, sold by Bristol-Myers Squibb and
AstraZeneca Plc, and Victoza from Danish drugmaker Novo
Like those medicines, dulaglutide belongs to a class of
injected drugs known as GLP-1 receptor agonists that work by
increasing the release of insulin after meals and by slowing
absorption of food in the gastrointestinal tract.
Doctors are still likely to initially reach for oral drugs
such as metformin for type 2 patients, but an injectable drug
that needs to be taken only once a week could become an
important treatment, researchers said, as diabetics often need
two or three medicines to properly control blood glucose.
"I believe the use of GLP-1s will continue to increase and
this new formulation of a once-a-week administration will be
very attractive to patients and physicians," said Umpierrez, a
professor of medicine at Emory University in Atlanta who
presented data from one of the trials at the meeting.
While data from the three studies appears to show a
comforting safety profile, dulaglutide will be under intense
scrutiny from health regulators. The GLP-1 class, and the DPP-4
inhibitors to which Januvia belongs, have been associated with
unconfirmed reports that they may cause serious inflammation of
the pancreas and cell changes that can lead to cancer.
Two cases of pancreatic cancer reported among study
participants were deemed highly unlikely to be connected to
dulaglutide, the company and researchers said.
Lilly said there were similar rates of pancreatitis among
patients taking comparator drugs or a placebo.
"There is no concern so far of pancreatitis or pancreatic
tumors," Umpierrez said.
One of the studies dubbed Award-1, involving 978 patients
over 52 weeks, tested dulaglutide against Byetta, a which is
injected twice a day. Subjects in the study were already taking
metformin and Takeda Pharmaceutical Co's Actos.
Adding dulaglutide to this mix helped 80 percent of patients
reach target blood sugar levels - an A1c of 7 - compared with
about 50 percent of those taking Byetta.
Dulaglutide and Byetta patients on average lost 3.3 pounds
(1.5 kilograms), an attractive side benefit as obesity is a
leading cause of type 2 diabetes.
In a separate 52-week study called Award-3, researchers
tested dulaglutide against metformin - the most commonly used
initial treatment for type 2 diabetes - in 807 patients earlier
in their disease progression. They began the trial with an
average A1c of 7.6 percent, above the ADA target of 7 percent.
People who took a 1.5 mg dose of the Lilly drug saw an
average drop in their A1c of 0.8 percent, with 62 percent of
patients getting to target blood sugar levels. That compared
with a drop of 0.56 percent for metformin with 54 percent
getting to goal.
Weight loss with dulaglutide was about 4.4 pounds (2 kg) and
3.3 pounds (1.5 kg) for metformin.
A third trial, dubbed Award-5, was a two-year study that
tested dulaglutide against Januvia in more than 1,000 patients
who were already taking metformin.
Patients who got dulaglutide had an average A1c reduction of
1.1 percent, with 60 percent of them achieving target levels,
versus a reduction of 0.4 percent for Januvia with 30 percent
getting to the ADA goal.
Average weight loss with the Lilly drug was 7 pounds (3.2
kg), while Januvia patients lost an average of 3.5 pounds (1.6
kg). The most common side effect reported in the three studies
for dulaglutide was nausea, researchers said.