Two Takeda Diabetes Drug Applications, FDA Asks For More Info

Takeda says it has received a complete response letter from the FDA regarding NDAs (new drug applications) for alogliptin and fixed-dose combination alogliptin and pioglitazone – both diabetes type 2 investigational therapies. Takeda says it has recently been providing the FDA (Food and Drug Administration) with post marketing data from markets outside the USA. Takeda believes it can provide the additional information from post marketing data from non-USA markets, as well as findings from its current clinical trial program.
Thomas Harris, vice president, regulatory affairs, Takeda Global Research & Development Center, Inc., said:

“We will immediately request a meeting with the FDA to determine the appropriate next steps and are committed to addressing outstanding issues. We remain confident in the benefit that alogliptin will bring to patients with type 2 diabetes in the U.S., if approved.
Takeda has built a strong foundation in and maintained a robust focus on diabetes over the past 20 years, and we will continue to invest in developing a diverse range of innovative products for the growing type 2 diabetes population.”

What is Alogliptin?

Alogliptin is a DPP-4i (selective dipeptidyl peptidase IV inhibitor). It is an investigational drug for diabetes type 2 treatment in the USA, alongside exercise and diet.
Alogliptin slows down the inactivation of GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide). GLP-1 and GIP are incretin hormones which are involved in regulating blood glucose levels.
The most common adverse effects linked to alogliptin, according to a phase 3 program, include upper respiratory tract infection, headache, urinary tract infection, and nasopharyngitis.

Pioglitazone

Drugs containing pioglitazone have been available in the United States since 1999 for diabetes type 2 treatment, alongside exercise and diet.
In a communiqué online, Takeda wrote:

“The FDC (fixed dose combination) alogliptin and pioglitazone combines two complementary agents with distinct mechanisms of action, and if approved, will be the first type 2 diabetes treatment option in the U.S. to include both a DPP-4i and the thiazolidinedione (TZD) pioglitazone in a single tablet.”

Adverse events related to alogliptin and pioglitazone co-administration include influenza, urinary tract infection, back pain and nasopharyngitis.
According to the Wall Street Journal, shares of Furiex Pharmaceuticals Inc. dropped 26%. Furiex is a partner drug developer with Takeda.

Cheap prescription Glasses and Product Review

This video is a product review on how and were to get cheap eyeglasses starting at $6.95 http://bit.ly/IXxqZQ and receive 15% off of your purchase using promo code IFSW4F2T4X

Long-Overlooked Protein May Be The Gateway To The Storage And Burning Of Fat, Diabetes Treatment

Humans are built to hunger for fat, packing it on during times of feast and burning it during periods of famine. But when deluged by foods rich in fat and sugar, the modern waistline often far exceeds the need to store energy for lean times, and the result has been an epidemic of diabetes, heart diseaseand other obesity-related problems.
Now, scientists at the Salk Institute for Biological Studies have identified the linchpin of fat metabolism, a protein known as fibroblast growth factor 1 (FGF1), which may open new avenues in the treatment of diabetes.
In a paper published in Nature, the Evans lab reports that FGF1 activity is triggered by a high-fat diet and that mice lacking the protein swiftly develop diabetes. This suggests that FGF1 is crucial to maintaining the body’s sensitivity to insulin and normal levels of sugar in the blood.
“Because humans are good at storing fat during times of plenty, we are also excellent at surviving times of famine,” says Ronald M. Evans, a professor in Salk’s Gene Expression Laboratory and lead author of the paper. “The fat tissues of our body are like batteries, providing us with a steady source of energy when food is scarce. FGF1 governs the expansion and contraction of fat and thus controls the ebb and flow of energy throughout our body.”
Obesity rates have soared in the United States in recent decades, with more than one third of U.S. adults and 17 percent of children and adolescents now considered obese, according to the Centers for Disease Control and Prevention.
As the number of overweight people has grown, so too has the incidence of metabolic disease, with nearly 26 million Americans estimated to have obesity-related type 2 diabetes. With annual costs exceeding well over $200 billion, obesity is a chronic disease that is consuming a huge portion of our health care dollars.
Although exercise and calorie restriction are known to be effective at preventing and treating diabetes, the obesity epidemic continues to grow and new drugs to treat the problem are desperately needed. Against this backdrop, the Evans’ lab discovery is an important breakthrough – and a surprise.
“The discovery of FGF1 was unexpected – and intriguing – because it was believed to do nothing,” says Jae Myoung Suh, a postdoctoral researcher in Evans’ laboratory and co-first author on the paper. “If you deplete FGF1 from the body, nothing happens when the mice are fed a steady low fat diet. But when given a high-fat, “Western-style” diet the mice develop an aggressive form of diabetes and experience a system-wide breakdown of their metabolic health.”
“These abnormalities cause abdominal or stomach fat to become inflamed,” says Michael Downes, a senior staff scientist in Salk’s Gene Expression Laboratory and co-lead author on the paper. “This is important because inflamed visceral fat has been linked to heightened risk for diabetes and other obesity-related diseases, such as heart disease and stroke.”
The scientists also found that FGF1 is regulated by the antidiabetic drug Actos, which is used to increase the body’s sensitivity to insulin. But Actos and related drugs, though helpful, have side effects that limit their use.
Thus, Evans and his colleagues plan to explore whether FGF1 might point to a new way to control diabetes by avoiding the drawbacks of Actos and providing a more natural means of increasing insulin sensitivity.

TSA destroys Teen’s Insulin Pump

Savannah Barry, a 16-year-old diabetic, is criticizing the TSA after an agent incorrectly instructed her to walk through a metal detector despite the fact she was wearing an expensive insulin pump. The pump stopped working shortly after the security check.

The TSA website provides the following guidance to diabetic travelers: “If you are concerned or uncomfortable about going through the walk-through metal detector with your insulin pump, notify the Security Officer that you…would like a full-body pat-down.” Barry followed those instructions last week as she tried to catch a flight out of Salt Lake City, but she was asked to walk through the body scanner anyway.

“When someone in a position of authority tells you it is — you think that its right,” Barry told ABC 4 Salt Lake City. “So, I said, ‘Are you sure I can go through with the pump? It’s not going to hurt the pump?’ And she said, ‘No, no you’re fine.’”

Then the pump stopped working.

The girl’s mother, Sandra Barry, quickly called the manufacturer of the pump, which couldn’t guarantee that it wasn’t damaged during the screening process, reports MSNBC. She was told to disconnect from the pump immediately after arriving home in Colorado, where she switched to insulin shots.

Ironically, Barry ended up having to be patted down and have ber bags searched anyway because screeners needed to inspect her insulin and packages of juice.

“When they saw her juice, they panicked and they didn’t know what to do,” Sandra Barry told ABC 7 Denver. “A diabetic is going to need a source of sugar, preferably liquid. I can assure you she’s not going to blow up a 737 with an insulin pump and three Capri Sun Juice(s).”

This incident highlights the need for TSA agents to be better educated in order to to deal with those who need medically necessitated pat downs, according to Sandra Barry, who has filed a formal complaint.

“It’s not a one-time thing and we’re going to keep putting the pressure on them,” she told MSNBC.

Late last month it was reported that some TSA agents have been hired without completing full background checks.

—————————-

What do you do when traveling? Have you experienced this type of treatment from the under qualified workers of TSA? What would you do if they tried to do this to you?

Doubts Over Long Term Impact Of Group Education For Diabetes Patients

A study published in BMJ (British Medical Journal) states that there are no long term benefits from type 2 diabetes group education programs that only take place once.
Type 2 diabetes, a chronic disease which can lead to amputation, loss of vision, kidney failure and many other health problems, requires a person to be extremely vigilant in caring for themselves when it comes to medication, treatment and caring for their symptoms. The UK’s Diabetes National Service Framework and the National Institute for Health and Clinical Excellence (NICE) both support and recommend education programs to diabetics, starting at the time they are diagnosed.
Former studies have shown that the Diabetes Education and Self Management for Ongoing and Newly Diagnosed, or DESMOND, was successful in giving patients a positive outlook and that patients’ feelings about their disease were improved. Their health also benefitted over a year, however, the study did not determine the long term effects of the program.
For this study, researchers recruited 731 of the 824 volunteers who were evaluated in the first study to determine the long term impact, over 3 years, of diabetes education programs.
The patients who were in the intervention group took 6 hour group programs, which were taught by 2 well trained healthcare professionals. The control group did not attend the structured classes, and followed routine care with their primary doctors.
The researchers collected data on the patients containing their body weight, cholesterol levels, and HbA1c (blood sugar) levels. They also looked at the patients’ history of depression, quality of life, lifestyle habits, beliefs about illness, what medications they were taking and how being diagnosed with diabetes made them feel.
Lifestyle and biomedical results at 3 years were the same with the intervention group and the control group, but the patients’ beliefs about illness seemed to have improved.
Another study, published today, focuses on program named “Talking Diabetes”, which focuses on healthcare professionals’ techniques of helping children deal with being diagnosed with type 1 diabetes. This particular study found that at 12 months, the program did not impact quality of life or blood glucose levels.
An accompanying editorial states that outcome of the trial is discouraging and that we should “focus again on the setting of appropriate targets by professionals who care for patients with diabetes and the patients themselves. “

Deals on Glasses from Eyebuydirect.com

 15% off all orders at EyeBuyDirect.com! Code: couponology15

just click the banner or the link

I got these single lens glasses for $2.82 using the promo code couponology15

The frames were $6.95 plus I had another coupon from a previous order that I had made so that gave me $3.00 off. Without that additional $3 it would have been $12 and some change. So go check them out and get yourself some new glasses. They also offer sunglasses

New Knowledge About Insulin Production Mapped By Stem Cell Researchers

Scientists from The Danish Stem Cell Center (DanStem) at the University of Copenhagen and Hagedorn Research Institute have gained new insight into the signaling paths that control the body’s insulin production. This is important knowledge with respect to their final goal: the conversion of stem cellsinto insulin-producing beta cells that can be implanted into patients who need them. The research results have just been published in the well-respected journal PNAS.
Insulin is a hormone produced by beta cells in the pancreas. If these beta cells are defective, the body develops diabetes. Insulin is vital to life and therefore today the people who cannot produce their own in sufficient quantities, or at all, receive carefully measured doses – often via several daily injections. Scientists hope that in the not-so-distant future it will be possible to treat diabetes more effectively and prevent secondary diseases such as cardiac disease, blindness and nerve and kidney complications by offering diabetes patients implants of new, well-functioning, stem-cell-based beta cells.
“In order to get stem cells to develop into insulin-producing beta cells, it is necessary to know what signaling mechanisms normally control the creation of beta cells during fetal development. This is what our new research results can contribute,” explains Professor Palle Serup from DanStem.
“When we know the signaling paths, we can copy them in test tubes and thus in time convert stem cells to beta cells,” says Professor Serup.
The new research results were obtained in a cooperative effort between DanStem, the Danish Hagedorn Research Institute and international partners in Japan, Germany, Korea and the USA. The scientific paper has just been published in the well-respected international journalPNAS (Proceedings of the National Academy of Sciences of the United States of America) entitled Mind bomb 1 is required for pancreatic β-cell formation.
Better control of stem cells
The signaling mechanism that controls the first steps of the development from stem cells to beta cells has long been known.
“Our research contributes knowledge about the next step in development and the signaling involved in the communication between cells – an area that has not been extensively described. This new knowledge about the ability of the so-called Notch signaling first to inhibit and then to stimulate the creation of hormone-producing cells is crucially important to being able to control stem cells better when working with them in test tubes,” explains Professor Palle Serup .
This new knowledge about the characteristics of the Notch signaling mechanism will enable scientists to design new experimental ways to cultivate stem cells so that they can be more effectively converted into insulin-producing beta cells.

Building Muscle Without Heavy Weights

Weight training at a lower intensity but with more repetitions may be as effective for building muscle as lifting heavy weights says a new opinion piece in Applied Physiology, Nutrition, and Metabolism.
“The perspective provided in this review highlights that other resistance protocols, beyond the often discussed high-intensity training, can be effective in stimulating a muscle building response that may translate into bigger muscles after resistance training,” says lead author Nicholas Burd. “These findings have important implications from a public health standpoint because skeletal muscle mass is a large contributor to daily energy expenditure and it assists in weight management. Additionally, skeletal muscle mass, because of its overall size, is the primary site of blood sugar disposal and thus will likely play a role in reducing the risk for development of type II diabetes.”
The authors from McMaster University conducted a series of experiments that manipulated various resistance exercise variables (e.g., intensity, volume, and muscle time under tension). They found that high-intensity muscle contractions derived from lifting heavy loads were not the only drivers of exercise-induced muscle development. In resistance-trained young men a lower workout intensity and a higher volume of repetitions of resistance exercise, performed until failure, was equally effective in stimulating muscle proteins as a heavy workout intensity at lower repetition rates. An additional benefit of the low-intensity workout is that the higher repetitions required to achieve fatigue will also be beneficial for sustaining the muscle building response for days.

My new glasses

My new glasses got them for $8.68 with RX if you use Ref Code IFSW4F2T4X you get 15% off and if you use coupon code COUPONOLOGY15 you get another 15% off. If you dont have your prescription you can go into any Optometry and have them read your glasses to tell you, and you will need your Pupil Distance. If you need a new RX then go to Wal-Mart and have your eyes checked its $40-$50. And then use that RX there at www.eyebuydirect.com that is where you will use the ref code and the coupon code. Hope this helps everyone.

Smoking sucks

Have you or a loved one been struggling with a smoking addiction. I have been an on again off again smoker since I was 14. I have seen first hand the damages that smoking has caused to my friends and family. My aunt died at 52 from lung cancer. My friend Bethany Carlson had to have open heart surgery because of a blocked artery caused by emphysema.
Once a status of the elite and glamorized by all the Hollywood starlets, we now know that smoking causes all sorts of health concerns and has even lead to death. Like I mentioned I have been an on and off smoker for years, but it wasn’t until I found http://beatingsmoking.com/ that I was able to put one down and never reach for another one.

They helped give me the tools and guidance that I needed to kick the urge and cravings and to make healthy choices. They showed me the showed me the link that I had with my addiction and taught me how to rewire my way of thinking and has freed me from it. I averaged about 2 packs a day, that’s $10.00 per pack here in Washington where I live; $20 something dollars a day. Between the price of gas and smoking I was basically working to smoke. I have saved now over $600 in the last two months just by not smoking anymore.

That’s money that I have used to spend time with my friends and family. I feel better, I am able to breath better, and just have a higher quality of life now. I urge you or someone you know to take up this cause once and for all and kick the habit. If I did you can too