Sue Marshall blogs about diabetes for Desang

Texas Researcher Poised to Test Leptin as a Replacement for Insulin Among Type 1s

April 23, 2010
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After mice “thrived” on the insulin-free regimen the hormone leptin offered, researchers are now ready to test the response on humans…

A University of Texas researcher who genetically modified mice with type 1 diabetes to control their disease with leptin instead of insulin is now ready to extend his experiment to human test subjects. Dr. Roger Unger, a researcher at the UT Southwestern Medical School in Dallas, will begin the tests as soon as leptin manufacturers can assure him of a steady supply of the hormone.

While other studies have indicated that the hormone may help control blood sugar levels, Unger and his associates were the first to experiment with leptin as a monotherapy in diabetes.

In his paper, “Leptin monotherapy in insulin dependent type 1 diabetes,” just published in the Proceedings of the National Academy of Sciences, Unger details how his team initially genetically modified diabetic mice to produce extra quantities of leptin. The mice were then taken off insulin and left to rely solely on leptin to control their blood sugar levels.

Unger reports that the mice thrived on the insulin-free regimen. Because genetic manipulation is not an option in human test subjects, the next step was to treat diabetic mice that had not been genetically altered with pump-delivered injections of leptin. Unger reports that those mice, too, did well despite the absence of insulin.

One reason for Unger’s desire to see if leptin can be a viable alternative to insulin is concern about the side effects produced by the typically large doses of insulin that most people with type 1 diabetes have to take. Among them are large fluctuations in blood sugar levels and possible long-term ill effects on blood vessels. In his experiments with leptin, Unger found that only low doses of the hormone were needed to maintain stable blood sugar levels.

Even as he undertakes tests with human subjects, Unger agrees with other diabetes experts that there is still a long way to go before leptin could be recommended as an alternative diabetes therapy. One important question the research may help answer is why leptin mimics insulin’s ability to deliver sugar to muscles and fat cells.

In comments on his paper, Dr. Barbara Kahn, a diabetes expert at Harvard Medical School and chief of endocrinology at Beth Israel Deaconess Medical Center in Boston, said that Unger’s research will have to address several other crucial questions:

  • Mouse and human eating patterns are very different. Mice graze constantly on food that takes a long time to digest, while humans eat several meals a day. Can leptin, which can maintain constant blood sugar levels in animals whose eating patterns do not create wide swings in the first place, work in humans, whose eating patterns invite such swings?
  • Unger’s mice had to be genetically altered to produce leptin, whereas most people with type 1 diabetes already produce normal amounts of leptin. What side effects might be created if the amount of leptin in their systems is increased?
  • Will leptin make it harder for type 1s to tell if they are having a hypoglycemic episode?

Whatever answers Unger’s further research delivers, they probably won’t help people with type 2 diabetes, who are resistant to both insulin and leptin.

via: Texas Researcher Poised to Test Leptin as a Replacement for Insulin Among Type 1s


Amylin Hopes to Begin U.S. Sales of Long-Acting Byetta Early This Year

April 13, 2010
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A new injectible drug that increases insulin sensitivity, slows glucose production, and decreases appetite is nearing final inspections…

Amylin Pharmaceuticals has announced that it expects to begin selling a once-weekly version of its diabetes drug, Byetta, by the end of the year. The company reports that the FDA is nearing final inspections of its manufacturing plant and could give the go-ahead for U.S. sales in early March.

Byetta, the commercial name for exenatide, is an injectible drug that increases insulin sensitivity, slows glucose production, and decreases appetite. Introduced in 2005, the drug has been used by several hundred thousand people, many of whom have reported dramatic weight loss while taking it. Users typically inject Byetta twice daily, once before their morning meal and once before their evening meal. The drug is usually used in conjunction with other diabetes therapies, such as metformin or sulfonylureas, but has been available since late 2009 as an FDA-approved monotherapy.

Amylin, which developed Byetta in conjunction with Eli Lilly and Co., has been looking for a more convenient way to deliver the drug ever since introducing it. The new product, called “once-weekly exenatide,” will require one injection every seven days, a far simpler and less uncomfortable routine.

One hurdle Amylin had to overcome in developing a long-term version was ensuring that the time-release technology used to  deliver Byetta at specific intervals during the week was reliable and robust. A larger hurdle has been FDA concerns about Byetta’s possible role in causing pancreatitis, a painful and debilitating inflammatory condition that in some cases ends in death. Although the FDA concerns have led to stronger warning language on the drug’s label, the statistical evidence has not been strong enough to prove causation. As a result, Byetta remains on the market, with more than 900,000 U.S. users.

Still, the company is concerned that FDA worries about a possible link to pancreatitis could slow the approval of long-acting Byetta. On the other hand, the FDA’s recent approval of Novo Nordisk’s Victoza, an injectible drug for type 2 diabetes that is chemically very similar to Byetta, may indicate that the agency is inclined to approve once-weekly exenatide.

San Diego-based Amylin, which took a financial hit from the pancreatitis concerns about Byetta and the introduction of rival drugs, is hoping that its long-term version will increase sales and attract patients who are tired of daily injections. The company and its partner, Eli Lilly and Co., believe that U.S. sales of the drug could reach $2 billion by 2015, compared to a projected $900 million in sales for Victoza in the same year. U.S. sales of Byetta in 2009 were an estimated $790 million.

via: Amylin Hopes to Begin U.S. Sales of Long-Acting Byetta Early This Year


Posted in diabetes, insulin
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Researchers Explore Potential Replacement for Insulin

April 12, 2010
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More research into how the weight loss hormone leptin works with insulin for better blood sugar control…

New research suggests that multiple daily insulin injections may one day be a thing of the past for people with Type 1 diabetes, according to a recent article published by BusinessWeek.

Researchers experimenting on mice say that the weight loss hormone leptin may one day replace or complement insulin shots in helping people with Type 1 diabetes maintain better blood sugar control. Previous research suggested the hormone may help people with Type 2 diabetes.

People with Type 1 diabetes do not produce insulin, the hormone that helps control the level of sugar in the blood, and therefore must inject the hormone into their body on a regular basis. People with Type 2 diabetes produce insulin, but their body does not use it efficiently. Some people can control their Type 2 diabetes through diet and exercise, but most need to take a pill or even insulin injections to regulate the sugar in their blood.

For this study, researchers treated Type 1 diabetic mice with insulin, leptin or a combination of the two hormones. What they found was that those treated with leptin or the combination of the two hormones showed better blood sugar control, lower cholesterol and lower body fat.  Researchers say the next step is human trials to see if the treatment works in humans.

via: Researchers Explore Potential Replacement for Insulin


Discovery of a Suspect Enzyme in Humans Could Lead to Powerful Type 1 Therapy

April 11, 2010
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A tale of mice and men… and some very complicated but positive enzyme research!

An enzyme that destroys pancreatic beta cells in lab mice has now been observed in human beta cells. Because scientists already know how to delete the mouse gene that produces the enzyme, they are hopeful that the same therapy can eventually be applied to people with type 1 diabetes. If so, it would be one of the most powerful therapies yet for addressing the destruction of insulin-producing beta cells that causes type 1.

Researchers at Eastern Virginia Medical School’s Strelitz Diabetes Center knew that the enzyme, 12-lipoxygenase (12-LO), produces lipids that cause inflammation, killing pancreatic beta cells in lab animals. They suspected that the same enzyme might also be responsible for beta cell death in humans. Thanks to people who donated their bodies to science through the Juvenile Diabetes Research Foundation Islet Resource Center Consortium, the Virginia researchers were able to confirm their suspicion-12-LO is present in human islets of Langerhans, which contain the insulin-producing cells. In some individuals, certain lipids produced by 12-LO inflame beta cells, leading to their death and an associated decline in insulin production that can range from drastic to total.

(more…)


Researchers Explore Potential Replacement for Insulin

April 8, 2010
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More research into how the weight loss hormone leptin works with insulin for better blood sugar control…

New research suggests that multiple daily insulin injections may one day be a thing of the past for people with Type 1 diabetes, according to a recent article published by BusinessWeek.

Researchers experimenting on mice say that the weight loss hormone leptin may one day replace or complement insulin shots in helping people with Type 1 diabetes maintain better blood sugar control. Previous research suggested the hormone may help people with Type 2 diabetes.

People with Type 1 diabetes do not produce insulin, the hormone that helps control the level of sugar in the blood, and therefore must inject the hormone into their body on a regular basis. People with Type 2 diabetes produce insulin, but their body does not use it efficiently. Some people can control their Type 2 diabetes through diet and exercise, but most need to take a pill or even insulin injections to regulate the sugar in their blood.

For this study, researchers treated Type 1 diabetic mice with insulin, leptin or a combination of the two hormones. What they found was that those treated with leptin or the combination of the two hormones showed better blood sugar control, lower cholesterol and lower body fat.  Researchers say the next step is human trials to see if the treatment works in humans.

via: Researchers Explore Potential Replacement for Insulin


‘Fat Hormone’ May Hold Key to Reversing Type 2 Diabetes | Diabetes News Hound

January 18, 2010
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Leptin, commonly referred to as the fat hormone, may hold the key to reversing Type 2 diabetes, according to a recent article on WebMD.

New research suggests that just a small amount of the hormone can control a gene in the liver that has shown to help diabetic mice. However, unlike other studies, which conclude that this hormone may help diabetics by promoting weight loss, the researchers in the current study suggests that the amount of the hormone used in this study is too small to promote weight loss. They say these results show that the benefits of this hormone on diabetes and on weight loss are independent of each other.

via ‘Fat Hormone’ May Hold Key to Reversing Type 2 Diabetes | Diabetes News Hound.


Relieving Stress on Insulin-Producing Cells May Prevent Diabetes – Diabetes Health

January 18, 2010
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BOSTON, Mass. – Dec. 23, 2009 – Cells in your body are constantly churning out poisonous forms of oxygen (oxidants) and mopping them up with a countervailing force of proteins and chemicals (anti-oxidants). This balancing act of oxidative stress is particularly likely to go haywire in beta cells, the insulin-producing cells that malfunction and then start to die off in type 2 diabetes.

Scientists at Joslin Diabetes Center now have found that a relatively little-studied enzyme plays a central role in defending beta cells against oxidants, but is damaged by the high levels of blood glucose produced in diabetes.

Joslin Principal Investigator Robert Stanton, M.D., who led the research, says the discovery raises hopes of finding drugs that protect the enzyme, and thus the beta cells and their insulin production. Such drugs could help to stem the tide against type 2 diabetes, which now afflicts more than a quarter of a billion people worldwide.

via Relieving Stress on Insulin-Producing Cells May Prevent Diabetes – Diabetes Health.


Posted in diabetes, insulin

Firm Seeking U.S. Approval for Faster-Acting Insulin | Diabetes News Hound

January 15, 2010
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Biopharmaceutical company Biodel, Inc is seeking U.S. Food and Drug Administration approval to market VIAject, an insulin that is designed to be absorbed into the blood faster than other current rapid-acting insulin analogues, according to a press release.

The company says VIAject helps reduce the risk of both hyperglycemia and hypoglycemia (low and high blood sugar levels). The insulin is meant to be used in insulin pumps as well as injected during mealtimes.

VIAject has been tested in more than 850 patients in Phase 1, 2 and 3 clinical trials in the U.S., Germany, and India.

via Firm Seeking U.S. Approval for Faster-Acting Insulin | Diabetes News Hound.


Novo Enters Phase 1 Test of an Insulin Pill – Diabetes Health

January 14, 2010
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On my wish-list for New Year: “Denmark-based Novo Nordisk A/S has begun phase 1 testing of an insulin pill that, if successful, could replace injections as the primary means of blood sugar control for millions of people with type 1 and type 2 diabetes. The company has enrolled 80 volunteer German test subjects in the study and expects to have preliminary results by the first half of 2011. The test group consists of both people with diabetes and people without it.”

via Novo Enters Phase 1 Test of an Insulin Pill – Diabetes Health.


Big Changes May Be In Store For The U.S. Insulin Market – TuDiabetes – A Community for People Touched by Diabetes

January 11, 2010
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Long, thorough and worthwhile article by Scott Strumello looking at what the future holds for insulin…. “The Future of Insulin Therapy Includes Some Names You Might Not Recognize … Yet! Once the floodgates were opened, what was once a boring, not very dynamic industry saw millions in new investments from researchers and startups (as well as established players) eager to cash in on insulin’s new-found status as a cash cow. Today, there are at least 3 late-stage insulin formulations (meaning they have all either completed Phase III clinical trials or are pretty close to and are planning to apply for FDA approvals in 2010), and several others aren’t too far behind. Interestingly, none of the newest insulin innovations are from the dominant players in the business (Novo Nordisk, Sanofi Aventis or Eli Lilly & Company), but from startups.”

via Big Changes May Be In Store For The U.S. Insulin Market – TuDiabetes – A Community for People Touched by Diabetes.


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