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Lilly once-weekly diabetes drug proves superior in late-stage trials

By Bill Berkrot

(Reuters) - 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 people.

"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 blood sugar.

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 Nordisk.

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.

SAFETY RISK?

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.

(Reporting by Bill Berkrot; editing by Julie Steenhuysen and Matthew Lewis)

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