“Merry Christmas” There is a Santa Claus and a God!

My Christmas Gift Came, I Am Out Of Rejection!

As many of you may know I have been battling rejection Since June of 2010.  Under going aggressive treatments that has taken a major toll on my body!  The past year and a half has been a real roller coaster ride to say the least.  With many medicine changes, oodles of trips to the lab for blood work, traveling and working with my transplant team, Dr. Nasser I. Youssef, Transplant Surgeon at Our Lady of Lourdes Medical Center (my rock)  and world renowned research scientist from Virgina Eastern Medical School (Dr. Aaron I. Vinik)  to Miami, a big thanks to my family at The Diabetes Research Institute, My friend Gary Kleiman and  Dr. Camillo Ricordi.  Also The University of Maryland Medical Center ~ Transplantation.   The support of my loving family and friends.  I am happy to share with you that this week, I beat my battle with rejection!  I am now out of rejection and my pancreas is working beautiful!  I’ve always said it and will say it again, I was blessed with an awesome donor.  May he enjoy his Christmas in the arms of Jesus and know how much his gift of life has been appreciated!

I will celebrated my Christmas with my close family and friends and start to rebuild my strength.  I thank everyone of you who prayed for me during this time, your spirits will always shine on in my heart!

Our motto at Diabetes Living Today® has always been:  May Kindness Always Be Our Guide! We wish all of you a very Happy Holiday filled with peace and joy!

Few With Diabetes Risk See Need for Lifestyle Counseling

Many patients who are at risk for developing type 2 diabetes do not perceive the need for lifestyle counseling, and even among those who see the need for counseling, less than half actually attend lifestyle interventions, according to a study published online Dec. 21 in Diabetes Care.

FRIDAY, Jan. 6 (HealthDay News) — Many patients who are at risk for developing type 2 diabetes do not perceive the need for lifestyle counseling, and even among those who see the need for counseling, less than half actually attend lifestyle interventions, according to a study published online Dec. 21 in Diabetes Care.

Sanna M. Salmela, of the University of Jyväskylä in Finland, and colleagues analyzed baseline and intervention data from 10,149 participants in the Finnish National Diabetes Prevention Project.

The researchers found that only 36 percent of at-risk men and 52 percent of at-risk women perceived the need for lifestyle counseling. Most diabetes risk factors did not increase the perceived need for counseling. Only among women was perceived need associated with actual attendance in the lifestyle intervention. Of those individuals who perceived the need for counseling, 35 percent refused to participate; among those who agreed to participate in supervised lifestyle intervention within public health care, about 70 percent showed up at least once.

“Altogether, preventing diabetes would seem to require action from policy makers in all sectors and at all levels, not just from the health care system,” the authors write. “Finding additional means to support lifestyle change processes will be very important.”

Medtronic remote diabetes monitor gets US approval

CHICAGO – Medtronic Inc on Wednesday said it received U.S. regulatory approval for the first remote glucose monitor that will let parents check the blood sugar of a diabetic child sleeping in another room.

 

About three out of four severe hypoglycemic reactions, in which a diabetic’s blood sugar drops to a dangerously low level, occur overnight. Parents of children with diabetes typically get up several times a night to check whether the child’s blood sugar is within healthy levels.

The bedside monitor, with an alarm that alerts the caregiver to blood glucose changes, helps protect against low blood sugar episodes, which can lead to seizures or even coma or death. Parents and other caregivers can see a child’s or adult’s glucose trends and insulin pump information on the device, called the mySentry Remote Glucose Monitor, and can take action to prevent a further decline in blood sugar if needed or remain in bed if all is well.

Britta Bushnell, whose 11-year-old son Kaden Kessel was diagnosed with type 1 diabetes when he was 2, is used to getting up during the night to check her child’s blood sugar. She believes having a monitor could have prevented two low-glucose episodes that caused Kaden to temporarily lose the use of his limbs and ability to speak.

The suburban Los Angeles mother received a monitor last summer as part of Medtronic’s evaluation process for the device.

“It gives a peace of mind at night that is just very difficult to have any other way,” Bushnell said in an interview.

When Kaden is older, the monitor will be placed beside his bed where it will wake him when he is ready to take care of his own insulin needs. “This puts college in a whole new light for me,” Bushnell said.

The mySentry monitor, which costs about $3,000, works with Medtronic’s MiniMed Paradigm Real-Time Revel System, an insulin pump with built-in continuous glucose monitoring. In addition to displaying blood sugar readings, the device provides information on the insulin pump battery life and amount of insulin remaining.

About 3 million Americans have type 1 diabetes, a disease in which the immune system destroys cells in the pancreas that make insulin. Patients must monitor their blood sugar and inject themselves with insulin throughout the day to prevent potential complications such as blindness, heart disease and kidney disease.

Medtronic, a leading maker of insulin pumps and continuous glucose monitors, is among the companies and researchers working to develop an artificial pancreas system that ultimately would provide insulin dosing automatically.

The company’s most advanced insulin pump, the Paradigm Veo, includes an automated safety feature called low-glucose suspend that shuts off the insulin flow when glucose falls low. The device, connected to patients through a small catheter placed just under the skin, is sold in 50 countries outside the United States.

Medtronic recently received approval to begin a U.S. clinical study for the device that will enroll a minimum of 285 patients at 20 U.S. sites. The company hopes to be able to sell the product in the United States in about 2-1/2 years, Greg Meehan, general manager of Medtronic’s continuous glucose monitoring business, said in an interview.

Medtronic is also looking to develop monitoring technology that can one day work with consumer devices including mobile phones, Meehan said.

“This is the first step in what we think is going to be a significant innovation category for diabetes care in the future,” he said.

Kitty Castellini Wins Roche Diabetes Care’s Diabetes Heroes’ Torchbearer Challenge Roche to make $10,000 donation in Castellini’s name to South Jersey JDRF Chapter

Indianapolis, Dec. 2, 2011

INDIANAPOLIS—Roche Diabetes Care, makers of ACCU-CHEK products and services, is pleased to announce that Diabetes Living Today® Founder, President and CEO Kitty Castellini is the winner of Roche’s inaugural Diabetes Heroes’ Torchbearer Challenge.

Roche launched the online Diabetes Heroes program earlier this year to highlight and recognize historic and present-day individuals who have made important contributions to help others live full lives with diabetes. The site contains three groups: Trailblazers, Torchbearers and Everyday Heroes.

Trailblazers are scientists and researchers who have made important historic discoveries about how diabetes is diagnosed and treated. Torchbearers are present-day researchers, advocates and online community leaders who continue to blaze new trails in helping people with diabetes to live healthy, active lives. To increase the visibility of this very important group of modern-day heroes, Roche produced online video profiles of each Torchbearer and encouraged people to visit the site and “like” their favorite by Nov. 14, 2011, World Diabetes Day. Castellini received the most likes and as a result Roche will donate $10,000 in her name to the South Jersey JDRF Chapter.

“A diabetes hero is an ordinary person who finds the courage and strength to persevere and endure in spite of the overwhelming obstacles of diabetes,” said Castellini.

The Diabetes Heroes site remains active and will continue to promote the incredible work being done by Kitty and her colleagues to assist people living with diabetes. Visitors to the Diabetes Heroes website may also add their own Everyday Hero by visiting the site and adding their own hero to the growing list.

 

For more information about Diabetes Living Today®, please visit http://diabeteslivingtoday.com. To learn more about the Diabetes Heroes website, please visit http://www.accu-chek.com/microsite/heroes/index.html.

###

About Roche Diabetes Care

Roche Diabetes Care is a pioneer in the development of blood glucose monitoring systems and a global leader for diabetes management systems and services. For more than 30 years, Roche has been committed to helping people with diabetes live lives that are as normal and active as possible and has been helping healthcare professionals manage their patients’ condition in an optimal way. Today, the ACCU-CHEK portfolio offers people with diabetes and healthcare professionals innovative products, services and comprehensive solutions for convenient, efficient and effective diabetes management—from blood glucose monitoring through information management to insulin delivery. The ACCU-CHEK brand encompasses blood glucose meters, infusion pumps, lancing and data management systems. For more information, please visit accu-chek.com.

 

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2010, Roche had over 80,000 employees worldwide and invested over 9 billion Swiss francs in R&D. The Group posted sales of 47.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.

 

About Kitty Castellini

Kitty Castellini, Founder, President and CEO of Diabetes Living Today®, has more than 47 years of experience with diabetes. Castellini is recognized as a national thought leader about diabetes by pharmaceutical companies, research institutes and those living with the disease. She is an active advocate for cure-focused research and fundraising. In 2007, the U.S. Congress acknowledged Castellini’s impressive work in helping others who suffer from diabetes through her writing, fundraising and interviews. The State of New Jersey Senate honored her for her exemplary service, steadfast commitment and praiseworthy history of inspired leadership on behalf of her fellow citizens.

 

All trademarks used or mentioned in this release are protected by law.

 

For further information, please contact:

Todd Siesky
Public Relations Manager 

Roche Diabetes Care

Indianapolis, IN

(317) 521-3966 O 

(317) 361-7637 C

todd.siesky@roche.com

 

Reduced-calorie diet could beat diabetes in four months

Study found that a low-calorie diet helped eliminate insulin dependence

A new study announced this week suggests that an extreme, low-calorie diet could beat Type 2 diabetes in just four months.

According to a study presented at Chicago’s Radiological Society of North America this week, a low-calorie diet eliminated insulin dependence and reduced amounts of dangerous fats around the heart in obese patients with Type 2 diabetes — even better than any prescribed medication.

To reach their findings, a team from Leiden University Medical Center in the Netherlands analyzed cardiac function and pericardial fat (the fat around the heart) in 15 patients with Type 2 diabetes — including seven men and eight women. Subjects consumed a diet consisting of just 500 calories a day for four months. Changes in body mass index (BMI) were also measured.

“It is striking to see how a relatively simple intervention of a very low-calorie diet effectively cures Type 2 diabetes,” said lead researcher Sebastian Hammer in a statement. “Moreover, these effects are long term, illustrating the potential of this method. Lifestyle interventions may have more powerful beneficial cardiac effects than medication in these patients.”

While the results are promising, not all patients are eligible for this type of therapy, warned the researchers, adding that patients should consult with their doctors before beginning any type of reduced-calorie diet.

In another study announced this summer, scientists from Newcastle University in the UK enlisted 11 people with Type 2 diabetes in an eight-week diet, cutting their daily calorie intake to just 600 calories a day. Within a week, the volunteers’ blood sugar levels returned to normal. Within months after returning to a normal diet, seven of the 11 volunteers remained free of the disease.

Calorie restriction cures diabetes? What study says

(CBS) Have scientists hit upon a simple cure for diabetes? New research shows that calorie restriction goes a long way toward eliminating the health problems that go hand in hand with type 2 diabetes.

To test the effect of calorie restriction, Dutch researchers enlisted 15 obese men and women with type 2 diabetes and used MRI scans to check their hearts for fatty deposits that are known to impair cardiac function, according to a written statement released by the Radiological Society of North America. Then they had the volunteers follow a 500-calorie-a-day diet for four months and re-scanned their hearts.

What happened? The volume of pedicardial fat fell significantly – from 39 milliliters to 31 milliliters. At the same time, the so-called “E/A ratio,” a common measure of cardiac function, rose from 0.96 to 1.2. And body mass index (BMI), an indicator of body fat, fell from 35.3 to 27.5.

A BMI of 30 or higher indicates obesity, while a BMI of 25 to 29.9 indicates overweight, according to the website of the National Heart Lung and Blood Institute. The BMI of normal weight people ranges from 18.5 to 24.9.

Perhaps most striking, all of the volunteers were able to discontinue their insulin injections after embarking on calorie restriction, study author Dr Sebastiaan Hammer of the department of radiology at Leiden University Medical Center told Medscape. “It is striking to see how a relatively simple intervention of a very low calorie diet effectively cures type 2 diabetes mellitus,” he said in a written statement.

Dr. Hammer – whose research was presented in Chicago at the society’s annual meeting – said the benefits of calorie restriction persisted even after the volunteers went back to their usual eating habits and regained weight. “These effects are long-term, illustrating the potential of this method,” he said.

But calorie restriction may not be for everyone with diabetes, Dr. Hammer said, adding that  diabetics considering trying it should consult a doctor beforehand.

The CDC estimates that diabetes affects 25.8 million people in the U.S., or roughly 8 percent of the population. The vast majority of cases are type 2 diabetes, the type associated with obesity.

The American Diabetes Association has more on diabetes.

FDA Clears Portable Insulin Pump from San Diego’s Tandem Diabetes

The FDA has cleared the first commercial product from San Diego’s Tandem Diabetes Care, a wearable insulin pump, according to a statement today from the medical device startup. Tandem Diabetes says its “t:slim” insulin pump represents an advance in terms of practicality and ease of use for managing type 1 diabetes—particularly for people who manage their diabetes with multiple daily injections.

As I reported in August, when Tandem Diabetes raised $12 million in venture funding, the company applied for FDA clearance under 510(k), a section of the Food, Drug, and Cosmetic Act that allows the regulatory agency to determine if a medical device is equivalent to existing technology already cleared for use.

Tandem Diabetes says its insulin pump enables patients to get insulin continuously throughout the day using a catheter, instead of giving themselves periodic injections. In a seeming homage to Apple’s simplicity of design, the San Diego company also emphasizes the t:slim’s thin design—”the smallest insulin pump system currently available,” user-oriented features, and “vivid color touch screen.” The device also features an “eco-friendly rechargeable battery” and can be connected via a USB port to a Web application so users can upload as much as 90 days of insulin pump data or blood glucose meter data.

In its statement, the company says, “Of approximately 1.5 million people in the U.S. with type 1 diabetes, industry estimates indicate that only 20 to 30 percent use an insulin pump, despite clinical evidence that pump use can improve glycemic control and quality of life.”

A Tandem Diabetes spokeswoman declined to say how much venture capital the company has raised since it was founded in 2006. By my reckoning, it is at least $77.3 million. The company’s investors include Delphi Ventures, Domain Associates, HLM Venture Partners, Second Technology Capital Investors, and TPG Biotech.

Tandem Diabetes is entering a market where many insulin pump makers already are established, including Minneapolis-based Medtronic; Bedford, MA-based Insulet; Switzerland’s Roche; New Brunswick, NJ-based Johnson & Johnson; South Korea’s Sooil; and Japan’s Nipro.

Technology advances ease personal diabetes care

Insulin pumps, patch pumps, continuous glucose monitors can help you manage diabetes.

By Laura Isensee

lisensee@MiamiHerald.com

Insulin pumps, insulin pens and blood sugar monitors. Those are some of the latest devices that can make it easier for the millions of people with diabetes to manage the disease.

But even as new technologies take hold — and even more are on the horizon — it means patients need to be smart, educated consumers to choose the device that works for them.

“There has been an explosion of available medications, technologies and glucose-health tracking tools available for people living with diabetes. It is therefore important that consumers be mindful and research what is available and ensure that all major diabetes management decisions are discussed with the individual’s health care team,” said Kellie Rodriguez, director of education services at the Diabetes Research Institute, University of Miami.

Another resource, offered by the American Diabetes Association: an annual consumers guide.

No matter the technology, consulting with a certified diabetes educator and training is crucial, said Lois Exelbert, a board member for the local American Diabetes Association and director of the diabetes center at Baptist Hospital.

“Somebody who goes on a pump without the proper education risks dangerous consequences,” she said. “They can have a kink in the pump and not know it, or they can miscalculate a dose if they are not properly informed.”

With that caveat, here are some options to review with your doctor and diabetes educator.

INSULIN PUMPS

New ‘smart’ pumps form the cornerstone of technological advancement, Rodriguez said. They provide the closest tool to replicate how our bodies deliver insulin. There are currently four on the market:

•  Omnipod by Insulet;

•  One Touch Ping by Animas / Johnson & Johnson;

•  Revel by Medtronic; and

•  Spirit by Roche.

All have similar options to deliver insulin: calculators, the ability to vary the amount of basal, or baseline, insulin, and delayed injections. Some have additional features. For example, the Omnipod offers a tubeless pump; the One Touch Ping has a remote insulin calculation and delivery and personalized food diary; and the Revel combines the pump with continuous glucose monitor capabilities.

In the future, there could be pumps that automatically shut off if someone has hypoglycemia, Rodriguez said. The ultimate goal: incorporate a patch pump to detect glucose and respond to changes — independent of the patient.

For Astrid Matthysse, who uses the One Touch Ping, the elimination of injections wasn’t the most important change. “Just the freedom I have with the pump — an easier lifestyle,” she said. Matthysse, 51 and the mom of two college kids, keeps a busy schedule. She works as a clinical manager for Animas and is earning a master’s degree in international business.

“When I was on injections, I had to stop to eat, otherwise my blood sugar would drop too low. Now with the pump, I can eat whenever I want and my blood sugar will not be affected,” she said.

PATCH PUMPS

These offer another method to deliver insulin. They have an insulin reservoir, delivery system and cannula — an insertion device — all built into a small, wearable device that is disposable or semi disposable.

“Patch pumps simplify traditional insulin pump therapy — essentially they are tube-free pumps,” Rodriguez said. Insulet’s Omnipod is available in the United States. A new patch is on the horizon for 2012: the V-Go, a fully disposable device to deliver basal and bolus insulin for adults.

Rodriguez said some of the benefits are that they are easier to use because there are no tubes; training is simplified; and the up-front costs are lower.

CONTINUOUS MONITORS

Continuous glucose monitors (CGMs) can give nearly 300 glucose readings in 24 hours; provide trending information, which is especially valuable overnight and after a meal.

Exelbert said continuous monitors are a key instrument for people whose blood sugar fluctuates a lot. Even if not used permanently, Exelbert said the continuous monitor can be used for a week as a diagnostic tool.

The benefit: more blood sugar readings and information if the level is headed down or up, she said. If someone tests their glucose every two hours, “what’s still missing in between is what happens to blood sugar and you don’t know if blood sugar is on the way up or down,” Exelbert said. “But by wearing a continuous glucose monitor you’re getting readings every five minutes and it’s telling you if it’s trending up or down.”

There are four continuous glucose monitor systems available on the market: DexCom; Guardian by Medtronic; I-Pro, and the Paradigm/Revel Insulin Pump sensor combination by Medtronic.

Della Matheson, a registered nurse and research coordinator at the Diabetes Research Institute, University of Miami, said she used to stick her finger eight to 10 times a day. With her continuous sensor — she uses DexCom — she can get a reading every five minutes.

“It gives me more information so I can anticipate where I’m headed and what I’m going to do behaviorally,” she said. “It [sounds an] alarm if you go below or above your target – it’s a hypoglycemia alert system.”

METERS AND PENS

People with diabetes can find both disposable and non-disposable insulin pens. The needles have become smaller and companies have made their own advances. For example, Lilly’s pen, called the Memoire, provides a reminder of when the last bolus of insulin was delivered and how much.

Matheson said the pens are more convenient. “You can carry them in your purse or your pocket, it makes it easier to take your insulin on the go,” she said.

Do the Big Blue Test and Change The World of a Person with Diabetes

Annual grassroots diabetes awareness campaign provides life-saving supplies to more than 8,000 people in need

BERKELEY, CA: Nov. 1, 2011 – People with diabetes will help change the lives for others with diabetes in need as they do something in unison – exercise. Every time someone participates in the Big Blue Test and shares the experience on BigBlueTest.org, a donation of life-saving supplies will be made on their behalf to someone with diabetes in need.

The Big Blue Test, a diabetes awareness program started by the nonprofit Diabetes Hands Foundation, takes place every November leading up to World Diabetes Day on Nov. 14. The campaign reinforces the importance of exercise in managing diabetes. People with diabetes are encouraged to do the Big Blue Test any day between November 1 and November 14 at midnight Pacific Time, by testing their blood sugar, getting active, testing again, and sharing the results online at bigbluetest.org.

The website aggregates all of the data collected live. In the last two years, just 14 minutes of exercise decreased participants’ blood sugar level between 15 and 20 percent.

In 2010, more than 2,000 people did the Big Blue Test. Over 120,000 people watched the Big Blue Test video. Roche Diabetes Care, makers of ACCU-CHEK® diabetes products and services, funded the production of the video and helped it go viral by donating 75 cents for each of the first 100,000 views, resulting in total donation of $75,000. The donation provided insulin and supplies to more than 2,000 people with diabetes in developing countries.

This year, in connection with the number of people that do the Big Blue Test, another donation from Roche Diabetes Care will benefit more than 8,000 people with diabetes in need. Five nonprofit organizations focused on helping underserved areas with a high incidence of diabetes in the United States will each receive $10,000, while $25,000 will go to support the work in Latin America by the International Diabetes Federation’s Life for a Child Programme.

“Exercise to help you – and help someone who really needs it get life-saving diabetes supplies,” said Manny Hernandez, President of the Diabetes Hands Foundation. “And join us in spreading the word so we can help 7,999 more!”

One of the recipients of the Big Blue Test grants will be Moundville Medical Clinic in Alabama. The clinic provides health services to underserved populations in rural Hale County, Alabama. In Hale County, the prevalence of diabetes runs high, while residents also face illiteracy, significant financial hardship, lack of transportation, and destruction left by 2011’s tornadoes.

“The Big Blue Test grant will enable us to provide free lab tests and individualized clinical pharmacy diabetes education and nutritional counseling to underserved people, including those impacted by the tornadoes,” said Heather Whitley, PharmD, BCPS, CDE, and director of the clinic’s diabetes program.

Visit BigBlueTest.org before midnight Pacific Time, November 14, 2011 to do the Big Blue Test, share the experience and help us touch the lives of 8,000 people with diabetes in need.

For high resolution photos of the participants in the video, visit:

http://www.tudiabetes.org/profiles/blogs/the-faces-of-the-2011-big-blue-test-video

 

About the Big Blue Test

The Big Blue Test started in 2009 as a creative way to encourage people with diabetes to stay active. It has grown into a global, viral campaign to raise awareness about the benefits of exercise for people with diabetes and help support diabetes charities in the process. It is a program organized by the Diabetes Hands Foundation, in collaboration with DiabetesDaily.com, DiabetesStories.com and the Psychology and Educational Sciences Department of the Internet Interdisciplinary Institute (IN3) at Universitat Oberta de Catalunya.

The 5 nonprofits that will benefit from $50,000 in Big Blue Test grants in the United States in 2011 are: LIFT For Teens/Walk and Play For Wellness in San Rafael, CA; Moundville Medical Clinic, near Tuscaloosa, Alabama, c/o Auburn University Harrison School of Pharmacy; Pecos Valley Medical Center, Inc. Pecos NM; St. Anthony Medical Clinic, St. Anthony Foundation in San Francisco, CA and University of Colorado Denver.

 

About World Diabetes Day

World Diabetes Day is celebrated on 14 November, a date chosen to mark the birthday of Sir Frederick Banting, one of the pioneers in diabetes research. It was introduced in 1991 by the International Diabetes Federation (IDF) and the World Health Organization (WHO) in response to the alarming rise in diabetes around the world. In 2007, the United Nations marked the Day for the first time with the passage of the United Nations World Diabetes Day Resolution in December 2006, which made the existing World Diabetes Day an official United Nations World Health Day. World Diabetes Day is represented by the blue circle logo—the global symbol of diabetes.

About Roche Diabetes Care

Roche Diabetes Care is a pioneer in the development of blood glucose monitoring systems and a global leader for diabetes management systems and services. For more than 30 years, Roche has been committed to helping people with diabetes live lives that are as normal and active as possible and has been helping healthcare professionals manage their patients’ condition in an optimal way. Today, the ACCU-CHEK portfolio offers people with diabetes and healthcare professionals innovative products, services and comprehensive solutions for convenient, efficient and effective diabetes management—from blood glucose monitoring through information management to insulin delivery. The ACCU-CHEK brand encompasses blood glucose meters, infusion pumps, lancing and data management systems. For more information, please visit accu-chek.com.

 

About Auburn University

Auburn University has provided instruction, research and outreach to benefit the state and nation for more than 155 years, and is among a distinctive group of universities designated as Land, Sea, and Space Grant institutions. Auburn makes a nearly $5 billion economic contribution to the state each year, has more than 250,000 graduates and provides 140 degree programs to more than 25,000 graduate and undergraduate students.

Takeda Resubmits New Drug Applications in the U.S. for Investigational Type 2 Diabetes Therapies Alogliptin and the Fixed-Dose Combination Alogliptin/Pioglitazone

DEERFIELD, Ill. and OSAKA, Japan, July 25, 2011 /PRNewswire/  — Takeda Pharmaceutical Company Limited (Takeda) announced today that Takeda Global Research & Development Center, Inc., resubmitted two New Drug Applications (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for alogliptin and the fixed-dose combination therapy alogliptin/pioglitazone, which combines alogliptin with pioglitazone in a single tablet. The FDA will review the NDA resubmissions within the next six months. Pioglitazone was approved in 1999 for the treatment of type 2 diabetes as an adjunct to diet and exercise. Alogliptin is a selective dipeptidyl peptidase IV inhibitor (DPP-4i) under investigation in the U.S. for the treatment of type 2 diabetes as an adjunct to diet and exercise. Discovered by Takeda San Diego, Inc., alogliptin is designed to slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide), which play a role in regulating blood glucose levels.

“We believe interim results from a cardiovascular outcomes trial satisfy the FDA’s cardiovascular safety requirements to allow the Agency to complete its review of our NDA, and further support the product profile of alogliptin,” said David Recker, M.D., senior vice president, clinical science, Takeda Global Research & Development Center. “If approved, alogliptin/pioglitazone will be the first type 2 diabetes treatment option in the U.S. to include both a DPP-4 inhibitor and a thiazolidinedione in a single tablet.”

The NDA resubmissions include interim results from the EXAMINE (EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome) study, a cardiovascular outcomes trial requested by the FDA to satisfy the criteria outlined in the December 2008 “Guidance for Industry: Diabetes Mellitus — Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes.” The EXAMINE study was designed to comply with the Guidance. This randomized, double-blind, placebo-controlled outcomes study continues to evaluate cardiovascular endpoints following treatment with alogliptin in addition to standard of care, versus standard of care alone, in patients with type 2 diabetes and a recent acute coronary syndrome (ACS). Final study results are expected in 2014.

“The NDA resubmissions mark a significant milestone for Takeda in the U.S., underscoring our deeply held commitment to providing therapeutic options for patients living with type 2 diabetes,” said Robert Spanheimer, M.D., vice president, medical and scientific affairs, Takeda Pharmaceuticals North America. “We are confident in the data available for alogliptin, and look forward to building upon our global expertise in the diabetes therapeutic area.”

Phase 3 Clinical Program

Twelve phase 3 clinical trials of alogliptin involving more than 8,000 patients were conducted in over 1,000 centers worldwide. The safety and efficacy of alogliptin was studied as a once-daily monotherapy adjunct to diet and exercise and as an add-on therapy to several other classes of antidiabetic medications, including metformin, thiazolidinediones (TZDs), insulin and sulfonylureas. In these studies, alogliptin 25 mg, taken once daily, demonstrated statistically significant reductions in hemoglobin A1c, which reflects average blood glucose concentration over the previous two to three months. The common adverse events (greater than or equal to 5% and greater than placebo) identified in this phase 3 program include headache, urinary tract infection, nasopharyngitis, and upper respiratory tract infection.

Of the 8,000 patients, the alogliptin/pioglitazone studies included more than 3,000 patients. Study results indicated that alogliptin/pioglitazone produced significant improvements in glycemic control. The common adverse events (greater than or equal to 5% and greater than placebo) identified in this phase 3 program include nasopharyngitis, back pain, urinary tract infection, and influenza.

About Type 2 Diabetes

Type 2 diabetes is the most common form of diabetes and has reached epidemic proportions globally. Almost 26 million Americans currently live with diabetes, and at least seven million are unaware that they have it. Type 2 diabetes is a progressive and chronic condition and patients should work with a health care professional to manage and monitor their disease. In addition to diet and exercise, patients often need to take multiple medications in order to help manage blood glucose control. The global health care expenditures to treat and prevent diabetes and its complications were estimated at $376 billion in 2010. By 2030, this number is projected to exceed $490 billion.

About Alogliptin and Alogliptin/Pioglitazone

Alogliptin is a DPP-4i being investigated, as an adjunct to diet and exercise, for the treatment of type 2 diabetes. DPP-4 inhibitors address insulin deficiency by slowing the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide). As a result, an increased amount of active incretins enables the pancreas to secrete insulin, in a glucose-dependent manner, thereby assisting in the management of blood glucose levels. An NDA for alogliptin was approved in April 2010 by the Japanese Ministry of Health, Labour and Welfare for the treatment of type 2 diabetes.

Alogliptin/pioglitazone is a fixed-dose combination therapy in development for the treatment of type 2 diabetes, which combines alogliptin and pioglitazone in a single tablet. Pioglitazone is a TZD that directly targets insulin resistance, a condition in which the body does not efficiently use the insulin it produces to control blood glucose levels, and is approved in adults for the treatment of type 2 diabetes as an adjunct to diet and exercise. An NDA for the alogliptin/pioglitazone fixed-dose combination was approved in July 2011 by the Japanese Ministry of Health, Labour and Welfare for the treatment of type 2 diabetes.

Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc.

Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology, and gastroenterology and cardiovascular treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for metabolic and cardiovascular disease, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.tpna.com.

Takeda Pharmaceutical Company Limited

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.

SOURCE Takeda Pharmaceutical Company Limited