Archive for October, 2011

insulin syringe

Photo credit: Pzado

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.

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.

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. Read the full article

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 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.<

diabetes medication

Photo: Leonardini

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. Read the full article

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.<

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. Read the full article

insulin syringe

Photo: Norman Desjardins

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.<

Insulin

Insulin crystals

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. Read the full article