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)

Source: http://news.yahoo.com/lilly-once-weekly-diabetes-drug-proves-superior-stage-150601939.html

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3 die in floods, 75,000 forced from Calgary homes

A police car sits stuck in a parking lot of an apartment building after heavy rains have caused flooding, closed roads, and forced evacuation in Calgary, Alberta, Canada Friday, June 21, 2013. (AP Photo/The Canadian Press, Jeff McIntosh)

A police car sits stuck in a parking lot of an apartment building after heavy rains have caused flooding, closed roads, and forced evacuation in Calgary, Alberta, Canada Friday, June 21, 2013. (AP Photo/The Canadian Press, Jeff McIntosh)

In this aerial photo, the flooded Cougar Creek runs through Canmore, Alberta, on Friday June 21, 2013. Communities throughout southern Alberta are dealing with overflowing rivers that have washed out roads and bridges, inundated homes and turned streets into dirt-brown tributaries. (AP Photo/The Canadian Press, Jonathan Hayward)

The Bow River overflows in Calgary, Canada on Friday, June 21, 2013. Heavy rains have caused flooding, closed roads, and forced evacuations in Calgary. (AP Photo/The Canadian Press, Jeff McIntosh)

A search and rescue boat carries rescued passengers from a flooded industrial site near highway 543 north of High River, Alberta, Canada on Friday, June 21, 2013. The rescued passengers spent the night moored on a structure they built in the water. Calgary's mayor said Friday the flooding situation in his city is as under control as it can be, for now. Officials estimated 75,000 people have been displaced in the western Canadian city. Mayor Naheed Nenshi said the Elbow River, one of two rivers that flow through the southern Alberta city, has peaked. (AP Photo/The Canadian Press, Jordan Verlage)

Firefighters monitor flood waters that spilled over a highway 543 north of High River, Alberta, Canada on Friday, June 21, 2013. The rescued passengers spent the night moored on a structure they built in the water. Calgary's mayor said Friday the flooding situation in his city is as under control as it can be, for now. Officials estimated 75,000 people have been displaced in the western Canadian city. Mayor Naheed Nenshi said the Elbow River, one of two rivers that flow through the southern Alberta city, has peaked. (AP Photo/The Canadian Press, Jordan Verlage)

CALGARY, Alberta (AP) ? At least three people were killed by floodwaters that devastated much of southern Alberta, leading authorities to evacuate the western Canadian city of Calgary's entire downtown. Inside the city's hockey arena, the waters reached as high as the 10th row.

Canadian Prime Minister Stephen Harper called the level of flooding "stunning" and said officials don't know yet if it will get worse, but said the water has peaked and stabilized and noted that the weather has improved.

Overflowing rivers washed out roads and bridges, soaked homes and turned streets into dirt-brown waterways around southern Alberta. Royal Canadian Mounted Police Sgt. Patricia Neely said two bodies were recovered and third was in an area that made it too dangerous to recover.

As the sun rose in Calgary on Saturday morning it wasn't raining. Some of the 75,000 flood evacuees were holding out hope they might soon be allowed back into their homes. However, Mayor Naheed Nenshi said earlier the downtown area was still without power and remained off limit. "It is extremely unlikely that people will be able to return to those buildings before the middle of next week," he said.

Nenshi also warned there could be another wave of danger ahead.

"There is a scenario in which upstream events at the dams further upstream from the city will lead to another surge in the Bow River," he said. "We don't know how realistic that scenario is, but we will have some hours warning if that actually happens."

The flood has hit some of the city's iconic structures hard. The Saddledome, home to the National Hockey League's Calgary Flames, was flooded up to the 10th row. That would mean the dressing rooms are submerged as well.

Harper, a Calgary resident, said he never imagined there would be a flood of this magnitude in this part of Canada.

"This is incredible. I've seen a little bit of flooding in Calgary before. I don't think any of us have seen anything like this before. The magnitude is just extraordinary," he said.

"We're all very concerned that if gets much more than this it could have real impact on infrastructure and other services longer term, so we're hoping things will subside a bit."

Twenty-five neighborhoods in the city, with an estimated 75,000 residents, were evacuated due to floodwaters in Calgary, a city of more than a million people that hosted the 1988 Winter Olympics and is the center of Canada's oil industry. About 1,500 have gone to emergency shelters while the rest have found shelter with family or friends, Nenshi said.

About 350,000 people work in downtown Calgary on a typical day. However, officials said very few people need to be moved out, since many heeded warnings and did not go to work Friday.

Alberta Premier Alison Redford said Medicine Hat, downstream from Calgary, was under a mandatory evacuation order affecting 10,000 residents. The premier warned that communities downstream of Calgary had not yet felt the full force of the floodwater.

A spokesman for Canada's defense minister said 1,300 soldiers from a base in Edmonton were being deployed to the flood zone.

Police were asking residents who were forced to leave the nearby High River area to register at evacuation shelter. The Town of High River remained under a mandatory evacuation order.

The flood was forcing emergency plans at the Calgary Zoo, which is situated on an island near where the Elbow and Bow rivers meet. Lions and tigers were being prepared for transfer, if necessary, to prisoner holding cells at the courthouse.

Schools and court trials were canceled Friday and residents urged to avoid downtown. Transit service in the core was shut down.

Residents were left to wander and wade through streets waist-deep in water.

Newlyweds Scott and Marilyn Crowson were ordered out of their central Calgary condominium late Friday as rising waters filled their parking garage and ruptured a nearby gas line. "That's just one building but every building is like this," he said. "For the most part, people are taking it in stride."

Crowson, a kayaker, estimated the Bow River, usually about four feet deep, is running at a depth of 15 feet (4.57 meters).

"It's moving very, very fast," he said of the normally placid stream spanned by now-closed bridges. "I've never seen it so big and so high."

It had been a rainy week throughout much of Alberta, but on Thursday the Bow River Basin was battered with up to four inches (100 millimeters) of rain. Environment Canada's forecast called for more rain in the area, but in much smaller amounts.

Calgary was not alone in its weather-related woes. Flashpoints of chaos spread from towns in the Rockies south to Lethbridge.

___

Associated Press writer Rob Gillies contributed from Toronto and AP writer Jeremy Hainsworth contributed from Vancouver, British Columbia.

Associated Press

Source: http://hosted2.ap.org/APDEFAULT/cae69a7523db45408eeb2b3a98c0c9c5/Article_2013-06-22-Canada-Alberta%20Flooding/id-dfb87231350b4dd9a94376dd2084bce2

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Michelle Obama honors military mothers at tea

First lady Michelle Obama gestures during a surprise visit from Prince Harry at an event in honor of military mothers in the East Room of the White House in Washington, Thursday, May 9, 2013. (AP Photo/Jacquelyn Martin)

First lady Michelle Obama gestures during a surprise visit from Prince Harry at an event in honor of military mothers in the East Room of the White House in Washington, Thursday, May 9, 2013. (AP Photo/Jacquelyn Martin)

First lady Michelle Obama, center, with Jill Biden, introduces a surprise visit from Prince Harry at an event in honor of military mothers in the East Room of the White House in Washington, Thursday, May 9, 2013. (AP Photo/Jacquelyn Martin)

WASHINGTON (AP) ? Michelle Obama and military mothers had high tea like the British on Thursday.

The afternoon White House affair, hosted by the first lady and Jill Biden, wife of Vice President Joe Biden, was to recognize the women for Mother's Day.

Britain's Prince Harry, who is on a weeklong visit to the U.S. devoted to the wounded victims of war, stopped by to salute them too.

Mrs. Obama thanked the mothers for their persistence.

"You all never complain, never complain, you just keep moving it along, getting it done, and I hope that you know how much this country appreciates you," she said.

She also called her mother, Marian Robinson, "my rock" and thanked her for teaching her patience.

"My mom has taught me most to be a good listener, to be patient, to use common sense," Mrs. Obama said. "She's taught me to be open minded."

Children accompanying their moms slipped into the State Dining Room to gather tulip and rose bouquets, baked vegetable chips and edible dough jewelry to present to their mothers.

The families dined in the East Room on light fare, including smoked salmon sandwiches, vegetable spring wraps, corn madeleines, mini cupcakes, bonbons and chamomile tea.

Associated Press

Source: http://hosted2.ap.org/APDEFAULT/89ae8247abe8493fae24405546e9a1aa/Article_2013-05-09-US-Michelle-Obama-Military/id-ac23053f0b454d3b9a2c85317fae44f3

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Texas Boy, 7, Shot By His Younger Brother, Police Say (VIDEO)

There's been another child-on-child shooting in America.

A 7-year-old boy was shot in his northeast Houston home on Tuesday -- and the gunman was apparently his younger brother, The Houston Chronicle reported..

According to ABC13.com, the boys were in the bathtub around 9 p.m. when their mother stepped away for a moment. Police say the 5-year-old brother then got out of the tub, found a .22 rifle and shot his older brother.

The injured child was transported to Memorial Hermann Hospital. Officials say the bullet went straight through the boy's back, KHOU.com reported. He is expected to recover.

At the time of this writing, no charges have been filed.

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Source: http://www.huffingtonpost.com/2013/05/08/texas-boy-shot-by-brother_n_3234438.html

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X-ray view of a thousand-year-old cosmic tapestry

Apr. 17, 2013 ? This year, astronomers around the world have been celebrating the 50th anniversary of X-ray astronomy. Few objects better illustrate the progress of the field in the past half-century than the supernova remnant known as SN 1006.

When the object we now call SN 1006 first appeared on May 1, 1006 A.D., it was far brighter than Venus and visible during the daytime for weeks. Astronomers in China, Japan, Europe, and the Arab world all documented this spectacular sight. With the advent of the Space Age in the 1960s, scientists were able to launch instruments and detectors above Earth's atmosphere to observe the Universe in wavelengths that are blocked from the ground, including X-rays. SN 1006 was one of the faintest X-ray sources detected by the first generation of X-ray satellites.

A new image of SN 1006 from NASA's Chandra X-ray Observatory reveals this supernova remnant in exquisite detail. By overlapping ten different pointings of Chandra's field-of-view, astronomers have stitched together a cosmic tapestry of the debris field that was created when a white dwarf star exploded, sending its material hurtling into space. In this new Chandra image, low, medium, and higher-energy X-rays are colored red, green, and blue respectively.

The Chandra image provides new insight into the nature of SN1006, which is the remnant of a so-called Type Ia supernova . This class of supernova is caused when a white dwarf pulls too much mass from a companion star and explodes, or when two white dwarfs merge and explode. Understanding Type Ia supernovas is especially important because astronomers use observations of these explosions in distant galaxies as mileposts to mark the expansion of the Universe.

The new SN 1006 image represents the most spatially detailed map yet of the material ejected during a Type Ia supernova. By examining the different elements in the debris field -- such as silicon, oxygen, and magnesium -- the researchers may be able to piece together how the star looked before it exploded and the order that the layers of the star were ejected, and constrain theoretical models for the explosion.

Scientists are also able to study just how fast specific knots of material are moving away from the original explosion. The fastest knots are moving outward at almost eleven million miles per hour, while those in other areas are moving at a more leisurely seven million miles per hour. SN 1006 is located about 7,000 light years from Earth. The new Chandra image of SN 1006 contains over 8 days worth of observing time by the telescope. These results were presented at a meeting of High Energy Astrophysics Division of the American Astronomical Society in Monterey, CA.

This work involved Frank Winkler, from Middlebury College in Middlebury, VT; Satoru Katsuda from The Institute of Physical and Chemical Research (RIKEN) in Saitama, Japan; Knox Long from Space Telescope Science Institute in Baltimore, MD; Robert Petre from NASA -Goddard Space Flight Center (GSFC) in Greenbelt, MD; Stephen Reynolds from North Carolina State University in Raleigh, NC; and Brian Williams from NASA -GSFC in Greenbelt, MD.

NASA's Marshall Space Flight Center in Huntsville, Ala., manages the Chandra program for NASA's Science Mission Directorate in Washington. The Smithsonian Astrophysical Observatory controls Chandra's science and flight operations from Cambridge, Mass.

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Source: http://feeds.sciencedaily.com/~r/sciencedaily/top_news/top_technology/~3/MCLCR9n2gko/130417165005.htm

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South Texas sees rise in illegal border crossings

>> we are back now with immigration reform , tonight we look at border security , a problem many consider central to the overall debate in a new "" wall street journal "" poll, 17% say the border is mostly secure.

>> they are running.

>> despite a dramatic drop in illegal immigration , there's been a rise in crossing of the border as many are fleeing the violence in central america . drug trafficking is also ramp ant here, innamie ining -- inflaming the argument for border reform. this is the chief deputy of brooks county texas, 75 miles north of the border . last year officials found the corpses of 129 immigrants who died after crossing the border . martinez fears that immigration reform will spark more illegal border crossings .

>> it has to, it just makes sense that it will increase the volume of people coming across.

>> elsewhere along the border in southern arizona , nbc news hit motion sensitive cameras and recorded these images of drug smugglers crossing private land. it's a concern for resident ares, and they say that this happens routinely. immigration reform cannot begin without first securing the border say the residents.

>> it's not secure at all, until you stop that, talking about anything else is just a waste of time.

>> another view is that a comprehensive immigration agreement could help secure the border . now you free up the agents to focus on narco traffickers who continue to plague our border .

>> but janet napolitano said that it's not only important to regulate the immigrant flow but also crack down on hiring violations.

>> we want to make it easier for employers to verify the legal residency or the legal presence of those working. and we want to make it easier for them to find a job.

>> the current immigration system is broken. and the argument insists on how to fix it without threatening border security .

Source: http://feeds.nbcnews.com/c/35002/f/653381/s/2aaf7462/l/0Lvideo0Bmsnbc0Bmsn0N0Cid0C51531135/story01.htm

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Eyeing Syria, White House woos regional rulers

WASHINGTON (AP) ? When President Barack Obama meets over the next month with leaders from Mideast and other regional nations, he will have a timely opportunity to try to rally the Syrian opposition's main backers around a unified strategy to oust Syrian President Bashar Assad.

Jordan, Turkey, Qatar and the United Arab Emirates ? whose Sunni Muslim leaders will meet separately with Obama starting April 16? are all believed to be arming or training rebel forces seeking to overthrow Assad's regime. But disparate political, geographic and religious considerations have led to conflicting approaches to which rebel factions to back and what kind of support to provide.

Infighting among mostly Sunni opposition groups and their failure to agree on a power structure to take over if Assad falls has been an important factor aiding the Alawite president as he clings to power two years into a civil war that has left at least 70,000 dead. Alawites are an offshoot of Shiite Islam, and the civil war has largely broken down along sectarian lines.

As resolute as Obama and most U.S. allies are that Assad must go, officials are increasingly worried about what Syria will look like if the regime falls before opposition groups can agree on a governing structure. That has resulted in extra U.S. pressure on regional allies to convince the opposition to unite.

White House spokesman Jay Carney said the high-level visits by leaders from the four nations reflect Obama's "deep personal interest" in the region and his commitment to the policies the U.S. is advocating.

"He will use these opportunities to discuss the complex developments in the broader Middle East," Carney said. "Not just Syria, but including Syria."

He pointed to other developments related to the Arab Spring and Obama's visit in March to Jordan, Israel and the Palestinian territories as other topics the president would likely discuss with the Arab leaders. Secretary of State John Kerry also is returning to the Middle East on Saturday for meetings on Syria and Israeli-Palestinian peace.

Additionally, senior Obama administration leaders at the White House, State Department and Pentagon held a high-level meeting Friday that focused on Syria among its top national security priorities, according to two officials familiar with the discussion who spoke on condition of anonymity because they were not authorized to disclose the talks to the news media. Senior U.S. officials have been meeting regularly to discuss a range of options on U.S. involvement in Syria, including whether to arm the rebels.

"We are constantly reviewing every possible option that could help end the violence and accelerate a political transition," said Caitlin Hayden, a spokeswoman for the National Security Council. "We are focusing our efforts on helping the opposition become stronger, more cohesive and more organized."

The global community's response to Syria will also be high on the agenda next Thursday, when Obama meets with U.N. Secretary-General Ban Ki-moon in the Oval Office. Washington has resisted arming the rebels, in part for fear that some weapons could fall into the hands of jihadi groups that are designated as terrorist fronts linked to al-Qaida.

But the U.S. has helped train some of the opposition fighters ? mostly former Syrian regime soldiers who have defected ? in Jordan and tacitly endorsed shipments of arms to the opposition from Qatar, Turkey and Saudi Arabia.

Additionally, Kerry said last month that the U.S. will not stop Western nations seeking to open the possibility of arming the rebels, including Great Britain and France.

But the bulk of the aid to rebels has come from Sunni-led governments in Turkey and the Mideast ? as several Shiite leaders in the regions have spirited weapons, fighters and aid to Assad's forces.

Turkey and Qatar, along with Saudi Arabia, are widely believed to have been providing rebels with tanks and surface-to-air missiles to fight regime soldiers. Salman Shaikh, a Mideast expert who specializes in Gulf politics, said those countries have strongly backed the opposition Syrian National Council and its allied fighters ? which include elements of the Muslim Brotherhood and Islamists, as well as secular groups.

The United Arab Emirates, by contrast, has been unenthusiastic about aiding Islamist elements of the opposition. Shaikh said the Emirates is believed to be sending limited weapons, like small firearms and ammunition, to secular fighters but mostly have focused on supplying the opposition with humanitarian aid.

Syria's protracted civil war has been particularly taxing for Jordan, a close U.S. ally that shared its northern border with Syria and has absorbed more than 460,000 refugees fleeing the conflict ? the equivalent of 10 percent of Jordan's population. It's been just a few weeks since a meeting between Obama and Jordan's ruler, King Abdullah II, in which Syria topped the agenda.

"We are extremely concerned of the risk of prolonged sectarian conflict that, if it continues as we're seeing, leads to the fragmentation of Syria," Abdullah said then, standing alongside Obama in Amman.

Jordan mostly has been helping train and arm rebel fighters who defected from Assad's forces and has done so with U.S. help. It also has served as a way station for rebels' weapons flow into Syria, and this week drew a harsh warning from Assad about "playing with fire" amid Jordanian fears that its larger neighbor might try to retaliate.

The two leaders will meet in Washington on April 26 in what one U.S. diplomat predicted will be Abdullah's attempt to ensure that he has full U.S. backing as Jordan's campaign to help the rebels continues. The diplomat spoke on condition of anonymity to discuss the talks more candidly.

"Regional players will find it difficult to always be singing off the same sheet," said Shaikh, director of the Brookings Doha Center think tank in Doha. "The U.S. hanging back and outsourcing a regional role is never going to achieve the goal of a unified opposition (to the regime) or even the military on the ground."

___

Associated Press writer Lolita C. Baldor contributed to this report.

___

Follow Lara Jakes on Twitter: https://twitter.com/larajakesAP

Follow Josh Lederman on Twitter: https://twitter.com/joshledermanAP

Associated Press

Source: http://hosted2.ap.org/APDEFAULT/89ae8247abe8493fae24405546e9a1aa/Article_2013-04-05-US-Syria/id-0b7f5de4d43847899a61a9cbd03745f8

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