$100,000 Reward Offered for Glucose-Sensitive Insulin

October 3rd, 2011

The Juvenile Diabetes Research Foundation (JDRF) announced a $100,000 Challenge for the development of a new glucose-sensitive insulin medication that will be used in the treatment of patients with diabetes. The JDRF is a global organization that promotes awareness of Type 1 diabetes in addition to sponsoring research into new treatments for diabetes and educating diabetics about how to properly manage the disease.

The JDRF is utilizing the InnoCentive.com platform to issue the challenge. InnoCentive is a service that connects businesses and organizations seeking solutions to problems in a wide variety of fields with scientists and research teams who develop solutions custom-tailored for the "challenge."

The best solution is awarded a cash prize, usually between $10,000 and $100,000. The JDRF's challenge will award $100,000 to any research group that develops a diabetes medication that improves blood sugar management, lessens the need for frequent blood sugar testing, and reduces the risk of diabetic complications.

The winning solution will be a glucose-responsive insulin medication that senses glucose levels in the blood of the patient and automatically releases insulin into the bloodstream when necessary. A glucose-sensitive medication would require fewer insulin doses - a single dose a day, or even less - and would reduce the burden of frequent blood sugar testing and insulin injections for diabetics.

According to Aaron Kowalski, Ph.D., assistant Vice President of Treatment Therapies at the JDRF, "Insulin treatment requires diligent monitoring and burdensome administration, often several times a day, every day. This remains the only way to regulate blood sugar levels for the millions of individuals with insulin dependent diabetes worldwide. Although research has propelled the development of better and faster-acting insulins, the disease is still hard to control because of the way insulin is administered to patients."

"What we need is sophisticated insulin that will take the guesswork out of managing diabetes by developing a novel insulin that works in the same way insulin works in people without diabetes," continued Dr. Kowalski. "By fostering novel approaches from diverse problem solvers within and outside the diabetes field, we hope this Challenge with InnoCentive will help speed progress toward the development of glucose-responsive insulin - progress urgently needed by people with diabetes."

InnoCentive.com is headquartered in Waltham, Massachusetts. The company's founders were first inspired to create a service connecting businesses with qualified researchers in 1998, and launched InnoCentive in 2001.

Enhanced Long Acting Insulin to Challenge Lantus

October 4th, 2011

(From Bloomberg Businessweek) Drugs to treat diabetes, mostly injectable insulin, have become a $34 billion annual business crowded with manufacturers of relatively similar products. Novo Nordisk wants to stand out from the pack. Following the example of consumer product companies, the Danish drugmaker is betting that it can add product enhancements to basic insulin and command higher prices in wealthier nations.

Explains Chief Executive Officer Lars Sørensen, pounding his desk for emphasis: "A country like the US ought to be able to offer people the most modern insulins and not giving them Third World insulins." Novo Nordisk, which gets half its $11.1 billion sales from insulin, this year is seeking U.S. and European regulatory approval for its newest treatment, degludec, in a bid to unseat Sanofi's Lantus as the world's best-selling diabetes medication.

Sørensen says degludec is "the fundamental part" of a strategy to boost Novo Nordisk's sales by shifting patients in developed nations from older, cheaper types of insulin that must be taken just before mealtimes to more expensive chemically altered versions that are absorbed more slowly and act longer.

Degludec's advantage is that it can be administered at any time, providing diabetes patients with greater flexibility, whereas Lantus insulin must be injected at the same time every day, although not necessarily at mealtimes. Trial results presented at a conference in Lisbon in September showed that degludec works as well as Lantus at controlling blood sugar.

To read the full article on Bloomberg Businessweek, >Click here.<

Novo Nordisk Files for Approval of Ultra Long Acting Insulin

October 5th, 2011

Insulin

Novo Nordisk today announced the submission to the U.S. Food and Drug Administration of two new drug applications for ultra-long-acting insulin degludec and the co-formulation, insulin degludec/insulin aspart. These insulin analogs have been developed for the treatment of people with type 1 and type 2 diabetes.

"We are very excited about being able to file for the approval of insulin degludec and insulin degludec/insulin aspart now also in the US," said Mads Krogsgaard Thomsen, Executive Vice President and Chief Science Officer at Novo Nordisk. "This is another significant milestone for Novo Nordisk and for the millions of people with diabetes who require insulin injections."

As with the European applications submitted on September 26, the U.S. filings are based on results from the BEGIN and BOOST clinical trial programs, which involved nearly 10,000 type 1 and type 2 diabetes patients. Data from the trials have shown insulin degludec to lower blood glucose levels, while demonstrating a low rate of hypoglycemia, especially at night.

The trials also showed that insulin degludec can be administered once daily at any time of the day with the possibility to change the insulin injection time from day to day according to the needs of the individual patient.

Novo Nordisk intends to make both diabetes medications available in a prefilled insulin delivery device. In the clinical trials, insulin degludec was studied in insulin pens that could either deliver up to 80 units or in a concentrated formulation up to 160 units in a single injection.

Insulin degludec is an ultra-long-acting basal insulin analog discovered and developed by Novo Nordisk. It forms multi-hexamers upon subcutaneous injection, resulting in a soluble depot from which there is a slow, continuous and extended release of insulin degludec. This may contribute to a lowering of blood glucose levels and low rates of hypoglycemia, especially at night.

Insulin degludec/insulin aspart contains the ultra-long-acting basal insulin degludec with a bolus boost of insulin aspart. Insulin degludec/insulin aspart is the first and only soluble insulin co-formulation of ultra-long-acting insulin degludec and insulin aspart providing both fasting and post-prandial control.

Should You Take a "Vacation" From Your Insulin Pump?

October 6th, 2011

insulin syringe

A veteran insulin pump user wrote a thought-provoking post for HealthCentral.com about "taking a vacation" from insulin pumping. It begins:

By Kelsey Bonilia

"One of the ideas I'd been mulling over in the weeks leading up to my endocrinologist appointment was taking a pump vacation.I'd experienced several frustrating pump site malfunctions (the cannula kept kinking during insertion) that left me with stubbornly high blood sugars for hours.It was maddening to have poor blood sugar control because of my insulin delivery system.Also, after nearly five years of insulin pumping, I just wanted the freedom of life without a little medical device tethered to me.

Upon discussion with my doctor, I made the comment "I know that the pump is best..." to which he replied, "For some people, but it's not inherently better." He knows that I eat a fairly disciplined diet and still test my blood sugar 10-12 times a day, so he agreed that switching to insulin injections would be fine for me. He prescribed Humalog and Lantus insulin pens, which I'd never used before.It was kind of exciting to open the boxes of pens and learn how to use a new device!"

Kelsey plans to update the pros and cons of switching to insulin injections after using an insulin pump for almost five years. To read this and future posts on HealthCentral.com, >Click Here.<

FDA Approves First Combo Drug for Diabetes And High Cholesterol

October 7th, 2011

The U.S. Food and Drug Administration today approved Juvisync (sitagliptin and simvastatin), a fixed-dose combination (FDC) prescription medication that contains two previously approved medicines in one tablet for use in adults who need both sitagliptin and simvastatin.

About 20 million people in the United States have type 2 diabetes, and they often have high cholesterol levels as well. These conditions can lead to increased risk of heart disease, stroke, kidney disease and blindness, among other chronic conditions, particularly if left untreated or poorly treated.

Sitagliptin is a dipeptidyl peptidase 4 (DPP-4) inhibitor that enhances the body's own ability to lower elevated blood sugar and is approved for use in combination with diet and exercise to improve glycemic control in adults with type 2 diabetes. Simvastatin is an HMG-CoA reductase inhibitor, or statin, approved for use with diet and exercise to reduce the amount of "bad cholesterol" (low-density lipoprotein cholesterol or LDL-C) in the blood.

"This is the first product to combine a type 2 diabetes drug with a cholesterol lowering drug in one tablet," said Mary H. Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research. "However, to ensure safe and effective use of this product, tablets containing different doses of sitagliptin and simvastatin in fixed-dose combination have been developed to meet the different needs of individual patients. Dose selection should factor in what other drugs the patient is taking."

This FDC is based on substantial experience with both sitagliptin and simvastatin, and the ability of the single tablet to deliver similar amounts of the drugs to the bloodstream as when sitagliptin and simvastatin are taken separately. Juvisync is a convenience combination and should only be prescribed when it is appropriate for a patient to be placed on both of these drugs.

Juvisync was approved in dosage strengths for sitagliptin/simvastatin of 100 mg/10 mg, 100 mg/20 mg and 100 mg/40 mg. The company has committed to develop FDC tablets with the sitagliptin 50 mg dose, as Juvisync 50 mg/10 mg, 50 mg/20 mg and 50 mg/40 mg. Pending availability of the FDC tablets containing 50 mg of sitagliptin, patients who require this dose should continue to use the single ingredient sitagliptin tablet. There is no plan to develop FDCs with the sitagliptin 25 mg dose as use of this dose is quite low.

Simvastatin is currently marketed in dosage strengths of 5, 10, 20, 40, and 80 mg. Due to recent restrictions placed on the use of the 80 mg dose because of a higher risk of muscle toxicity, there will not be a FDC using this dose. There is also no plan to develop FDCs with the simvastatin 5 mg dose as use of this dose is quite low as well.

The FDA has recently become aware of the potential for statins to increase blood sugar levels in patients with type 2 diabetes. This risk appears very small and is outweighed by the benefits of statins for reducing heart disease in diabetes. However, the prescribing information for Juvisync will inform doctors of this possible side effect. The company will also be required to conduct a post-marketing clinical trial comparing the glucose lowering ability of sitagliptin alone compared to sitagliptin given with simvastatin.

Juvisync is approved with a Medication Guide that provides important information to patients. The most common side effects of Juvisync include upper respiratory infection; stuffy or runny nose and sore throat; headache; muscle and stomach pain; constipation; and nausea. Juvisync is manufactured by MSD International GmbH Clonmel, Co. in Tipperary, Ireland.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Decade of Research Results in Discovery of a Diabetes Gene

October 11th, 2011

MADISON - Ten years of meticulous mouse breeding, screening, and record-keeping have finally paid off for Alan Attie and his lab members. The University of Wisconsin-Madison researchers' efforts, published Oct. 6 in the journal PLoS Genetics, pinpointed a gene that confers diabetes susceptibility in obese mice.

They also showed that the protein coded by the gene, called tomosyn-2, acts as a brake on insulin secretion from the pancreas. "It's too early for us to know how relevant this gene will be to human diabetes," says Attie, a UW-Madison biochemistry professor, "but the concept of negative regulation is one of the most interesting things to come out of this study and that very likely applies to humans."

In a properly tuned system, insulin secreted into the blood after eating helps maintain blood sugar at a safe level. Too little insulin (as in type 1 diabetes) or insulin resistance (as in type 2 diabetes) leads to high blood sugar and diabetic symptoms. Too much insulin can drive blood glucose dangerously low and lead to coma or even death in a matter of minutes.

"You can imagine that if you're in a fasted state, you don't want to increase your insulin, so it's very important to have a brake on insulin secretion," says Angie Oler, one of the lead authors. "It needs to be stopped when you're not eating and it needs to start again when you do eat."

The group honed in on tomosyn-2 while searching for genes that contribute to diabetes susceptibility in obese animals. Why study fat mice? To read the entire Press Release on FierceBiotech, >Click Here.<

Chewable Oral Diabetes Medication Enters Clinical Testing

October 12th, 2011

diabetes medication

Boston Therapeutics, Inc., a developer of diabetes therapeutics, announced the initiation of its first clinical trial of its investigational diabetes medication, PAZ320, when added to other oral diabetes medication or insulin injections in patients with type 2 diabetes. Boston Therapeutics is a leader in the specialized field of glyco-pathology, focused on understanding the importance of carbohydrates in biochemistry and the progression of diseases.

"We have already seen significant reduction of post-meal elevation of glucose in preclinical models with PAZ320," said David Platt, Ph.D., Chief Executive Officer of Boston Therapeutics. "We are excited about our collaboration with endocrinologist Dr. Sushela Chaidarun, PhD. and Dr. Laura E. Trask at Dartmouth Hitchcock Medical Center, and the possibility to help millions of people with high blood sugar and diabetes."

PAZ320 is a chewable complex carbohydrate-based compound designed to reduce the post-meal elevation of blood glucose. A proprietary polysaccharide designed to be taken before meals, it works in the gastrointestinal system, blocking the action of the carbohydrate-hydrolyzing enzymes that break carbohydrates down into glucose and release it into the bloodstream.

This clinical study will evaluate the safety and efficacy of PAZ320 when added to oral diabetes medications or insulin injections. The study population will consist of adults aged 18-75 years with type 2 diabetes, either on oral agents or insulin with a BMI of 25-35 kg/m2 and with A1c of less than 9.0%. The study will be conducted at Dartmouth-Hitchcock Medical Center in New Hampshire - one of America's oldest and most respected medical schools

"Given the many complications that stem from uncontrolled diabetes, it is important to implement measures that will better control glucose levels throughout the day," said Dr. Trask, Co-Principal Investigator of the study, along with Dr. Chaidarun. "By providing another way to appropriately control the postprandial glucose increase following a meal, diabetics may better control their glucose level."

Boston Therapeutics has also developed SUGARDOWN, a chewable complex carbohydrate-based dietary supplement that is taken before carbohydrate-containing meals to reduce the absorption of glucose from the intestinal tract and moderate post-meal blood glucose.

Scientists Cure Diabetes in Rat's Using Animals Own Stem Cells

October 17th, 2011

diabetes cured in rats

From Diabeteshealth.com

Using stem cells that they extracted from the brains of diabetic lab rats, and turning them into insulin-producing pancreatic cells, Japanese scientists may be on the road to a virtual cure for diabetes that comes from people's own brains. Led by Tomoko Kuwabara of the National Institute of Advanced Industrial Science and Technology in Tsukuba Science City, Japan, a team of scientists extracted neural tissue from the rats' olfactory bulbs or their hippocampuses. The former is the part of the brain is involved with smell while the former is involved with memory.

Because of both sites' location in the brain, extraction was easily done through the nose. The rats involved had either type 1 or type 2 diabetes. The scientists then extracted stem cells from the tissue and applied a human protein to them, Wnt3a, which "switches on" insulin production.

After two weeks, the cells had multiplied to the point that the researchers could lay collagen sheets impregnated with them gently on top of the diabetic rats' pancreases. Seven days later, the concentration of insulin in the blood of all the rats, whether type 1 or type 2, matched that of non-diabetic rats. Blood glucose levels were normal. To read the entire story on diabeteshealth.com, >Click Here.<

Discovery of Pancreatic Insulin Switches Could Lead to New Diabetes Drugs

October 19th, 2011

Researchers at the Salk Institute have discovered how a hormone turns on a series of molecular switches inside the pancreas that increases the production of insulin. The finding, published in the Proceedings of the National Academy of Sciences, raises the possibility that new designer diabetes drugs might be able to turn on key molecules in this pathway to help the 80 million Americans who have type 2 diabetes or pre-diabetic insulin resistance.

The molecular switches command pancreatic beta islet cells, the cells responsible for insulin, to grow and multiply. Tweaking these cells might offer a solution to type 1 diabetes, the form of diabetes caused by destruction of islet cells, and to type II diabetes, the form caused by insulin resistance.

"By understanding how pancreatic cells can be encouraged to produce insulin in the most efficient way possible, we may be able to manipulate those cells to treat or even prevent diabetes," says the study's lead author, Marc Montminy, a professor in the Clayton Foundation Laboratories for Peptide Biology at Salk.

To read the full article on ScienceDaily, >Click Here.<

Diabetes Drug Byetta Approved as Add-On to Long Acting Insulin

October 20th, 2011

The US.Food and Drug Administration has approved a new use for Amylin Pharmaceuticals Inc. and Eli Lilly's BYETTA injection. BYETTA is now approved as an add-on therapy to insulin glargine, with or without metformin and/or a thiazolidinedione (TZD). It should be used in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control on insulin glargine alone.

"This expanded use for BYETTA is important for clinical care, in that it provides a new option for the many patients with type 2 diabetes who are not achieving treatment goals," said John Buse, M.D., Ph.D., professor of medicine, director of the Diabetes Care Center and chief of the Division of Endocrinology at the University of North Carolina School of Medicine in Chapel Hill.

"BYETTA is well-suited for use with insulin glargine, offering a simple fixed-dose regimen that can help improve control of blood sugar overall and after meals. In a clinical trial, patients using BYETTA with insulin glargine achieved better glycemic control, without weight gain or an increased risk of hypoglycemia, compared to patients using insulin glargine alone."

BYETTA is not insulin and should not be taken instead of insulin. The diabetes medication should not be taken with short- and/or rapid-acting insulin. BYETTA should not be taken by type 1 diabetics, people with diabetic ketoacidosis or patients with a history of pancreatitis.

In the study supporting the expanded use, patients receiving insulin glargine, with or without metformin and/or a TZD, were randomized to receive BYETTA or placebo in addition to aggressive insulin titration. After 30 weeks of treatment, A1C decreased by 1.7 percentage points in patients adding BYETTA, compared with a decrease of 1.0 percentage point in patients treated with insulin glargine alone (p<0.001). A1C is a measure of average blood sugar over three months.

Nausea, which was the most common adverse event, occurred in 41 percent of patients treated with BYETTA compared with 8 percent of patients treated with insulin glargine alone.

BYETTA is an injectable diabetes medication that exhibits many of the same effects as the human incretin hormone GLP-1. GLP-1 improves blood sugar after food intake through multiple effects that work in concert on the stomach, liver, pancreas and brain.

BYETTA was the first glucagon-like peptide-1 (GLP-1) receptor agonist to be approved by the FDA for the treatment of type 2 diabetes, and is now the first and only GLP-1 receptor agonist approved for use in the U.S. as an adjunct to long-acting insulin glargine (Lantus), with or without certain oral agents.

The double-blind clinical trial evaluating BYETTA as an add-on therapy to insulin glargine was published in Annals of Internal Medicine.(i) In the study, 261 patients receiving insulin glargine with or without metformin and/or a TZD were randomized to receive BYETTA 10 micrograms or placebo. Patients who may have been at increased risk of hypoglycemia (A1C?8 percent) reduced their dose of insulin glargine by 20 percent.

Five weeks after randomization, all patients had insulin doses aggressively titrated to target fasting blood glucose. The primary endpoint was reduction in A1C; secondary endpoints included change in body weight along with other parameters of glucose control, cardiovascular health, hypoglycemia and patient-reported outcomes.

After 30 weeks of treatment, the proportion of participants achieving the target A1C?7 percent was 60 percent in the BYETTA group and 35 percent in the insulin glargine group (p<0.001). For the target A1C?6.5 percent, the proportions were 40 percent and 12 percent, respectively (p<0.001). Both groups showed lower fasting plasma glucose concentrations; however, after morning and evening meals, when BYETTA was administered, postprandial glucose control was significantly improved in patients treated with BYETTA, compared to placebo.

On average, weight decreased by 4 pounds in patients adding BYETTA, compared with an increase of 2 pounds in patients treated with insulin glargine alone (p<0.001). The greater improvement in A1C with BYETTA was not accompanied by an increase in hypoglycemia, compared to insulin glargine alone.

Updated Glycemic Index for Diabetic Diet

October 24th, 2011

insulin spike chartGlycemicEdge.com, a leading nutrition and health wellness community site, has updated and expanded its popular glycemic index food list and now features food scores from 12 categories of foods and nearly 200 individual foods.

The glycemic index is a scoring system which rates foods on a 0-100 basis according to their impact on digestion and insulin levels, based on the type of carbohydrates used. The glycemic index diet plan has become increasingly popular for wellness, weight loss, and has been particularly well received by pre-diabetics, diabetics, and those following a heart healthy cardiovascular health plan.

According to Wayne Mitchell of GlycemicEdge.com, the best part about the glycemic index diet is it's realistic approach to choosing foods while not banishing carbs. "Low carb and no carb diets are really challenging to follow. They also don't have the health benefits that "low GI" or good carb foods provide. With low glycemic foods, you get the benefit of feeling "fuller" with foods that put much less strain on your digestive system and pancreas, controlling the release of insulin."

Another popular benefit for low glycemic foods is weight loss, as your metabolism adjusts and switches from primarily burning carbs as a fuel source to burning fat. Whole grains and complex carbohydrates are emphasized while simple carbohydrates and foods which result in a sudden, rapid insulin spike during digestion rank high on the GI scale and should be avoided.

"Our users love the ability to compare foods, find some surprising foods that are good low GI choices, and print and take lists with them when they do their shopping and planning for their families. About 70% of our users are moms planning for their families, and the charts and food lists are a great resource to make this easier for them."

Users can print the lists for free and are invited to share questions and submit food scores of their own to help grow community awareness. Also featured are south beach diet food list and printable shopping guides.

New Ultra Fast Acting Insulin Does Well in Clinical Trials

October 26th, 2011

insulin syringe

Halozyme Therapeutics, Inc., a San Diego-based pharmaceutical company, recently announced that its new "ultrafast" insulin, PH20, worked just as well as Humalog in two Phase 2 clinical trials. PH20 is an insulin analog, a type of insulin that is not produced by the human body, but functions the same way as the insulin that the body produces.

The injectable insulin analog was as effective as another insulin analog - Eli Lilly's Humalog - at controlling blood sugar levels. In addition, PH20 was more effective than Humalog at controlling post-meal blood glucose levels. Rates of hypoglycemia were similar in PH20 insulin users, and the hypoglycemic episodes that did occur were generally mild and no more serious than those experienced by patients using Humalog.

Researchers studied the effects of the investigational diabetes medication on controlling blood sugar levels in two clinical trials conducted on about 220 participants. One study involved patients with Type 1 diabetes, and the other involved patients with Type 2 diabetes. There was a 50 percent increase in the number of patients who regularly met guidelines for healthy post-meal blood glucose levels among those using PH20 insulin injections.

PH20 insulin is delivered using rHuPH20, or recombinant human hyaluronidase enzyme. Much of Halozyme's work is based on the subcutaneous delivery of medications with rHuPH20, which the company says decreases costs, increases efficiency, and makes medication more convenient for patients.

Halozyme said that it will be pursuing worldwide distribution of PH20, suggesting that it may be partnering with a larger pharmaceutical manufacturer.