Archive for the ‘Insulin Delivery’ Category

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 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

(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.<

Is it safe to reuse an insulin syringe? Bethany from California asked this question of Conditions Expert Dr. Otis Brawley on the health website CNN Health. Dr. Otis’ answer reads in part:

“Insulin syringes are expensive, and many patients want to reuse needles to save money. Many also reuse the lancets used to prick the skin and draw blood to measure blood sugar.

You are right that the reuse of insulin syringes and lancets is dangerous. A used needle can have bacteria from the skin in and on it. Bacteria can contaminate the bottle of insulin when reinserted into the bottle. The bottled insulin is a growth medium that can allow the bacteria to reproduce. Insulin is stored in a refrigerator to prevent bacterial growth. Read the full article

The prosecutor in Alicante, Spain has requested a prison term of 29 years for a woman accused of murdering her husband with a lethal insulin dose.

Fifty-one-year-old Gregoria CS, a Spanish woman on diabetes medication since 1998, was responsible for administering medication to her husband, Juan Antonio GC, diagnosed with HIV.

Gregoria allegedly first dosed her husband with insulin on March 30th, 2007 after a family row, resulting in his admission to hospital in a hypoglycemic crisis. He remained in hospital for a month.

On a second occasion on June 28th, 2010, she injected her sleeping husband in the neck with a massive dose using three insulin pens, and when he woke up smothered his cries for help with a pillow.

The next morning the couple’s children raised the alarm when their father would not wake up. He was transferred to hospital in Elche with severe hypoglycemia and was stabilized, but remained in a vegetative state until his death on February 4th, 2011.

The woman had accused her husband of psychological abuse. The prosecutor’s requested term of imprisonment comprises 11 years for the first murder attempt and 18 years for the second.

From the online newspaper, RoundTownNews.

In another promising development in the world of diabetes medication, the specialty pharmaceutical company MonoSol Rx is testing its unique PharmFilm as a possible oral insulin delivery platform. PharmFilm is a quick-dissolving film that can be impregnated with medication and placed under the tongue or against the inside of the cheek. The medication is quickly absorbed into the bloodstream through the mouth’s mucosal membranes.

The FDA has already approved two applications of the edible film – Zuplenz to treat nausea and vomiting, and Suboxone to treat opiod dependence. MonoSol Rx is now testing two new applications for PharmFilm, one dispenses a drug to treat ADHD, and the other delivers insulin for diabetics.

Read the full article

Have you or someone close to you been newly diagnosed as an insulin dependent diabetic? Are you anxious about giving yourself or your dependent insulin injections? Many diabetics say that giving themselves an insulin injection is the hardest part of the condition.

Or perhaps you’re an experienced diabetic who hasn’t kept up to date on the latest insulin delivery methods like spring loaded syringes, insulin pens and insulin jet injectors. Skipping doses of diabetes medication can lead to poor blood sugar control and diabetes complications. WebMD feature writer Stephanie Watson offers some practical advice in an article titled Overcoming Objections to Injections.

V-Go Disposable Insulin Delivery Device

Valeritas, an American medical technology company focused on the development and commercialization of innovative drug delivery solutions, is poised to begin marketing a new disposable insulin delivery device called the V-Go Disposable Insulin Delivery Device.

The V-Go is designed to provide an alternative to multiple daily insulin injections for adult type 2 diabetics using basal-bolus insulin therapy. The V-Go delivers a continuous preset rate of basal insulin (20, 30 or 40 units of insulin per 24 hours) and allows for on demand bolus dosing at mealtimes (in two unit increments up to 36 units).

Users fill the V-Go with their desired insulin dose using an included disposable filling accessory, the V-Go EZ Fill. The small, lightweight (about 1 ounce when full) device delivers insulin subcutaneously for 24 hours, after which it is replaced with a new one. The discreet device is worn under a patient’s clothing, and should not be exposed to direct sunlight or high temperatures, although it can be submerged in up to three feet of water.

The non-electronic V-Go was tested using both Humalog insulin lispro and Novolog (insulin aspart), and achieved FDA approval at the end of 2010. The company has been pursuing financing to market it ever since, and has just announced that it has raised $150 million to bring the V-Go Disposable Insulin Delivery Device to market.

“Millions of adult patients suffer from type 2 diabetes and require insulin,” says Valeritas CEO Kristine Peterson, “We believe the V-Go will be an important treatment option to assist in the management of their diabetes.”  To visit the V-Go site and to sign up for email updates on the availability of the innovative insulin delivery device, >Click Here.<

VitaJet Insulin Jet Injector

Despite lackluster success to date, the market research firm Kalorama is predicting that the worldwide market for jet injectors will double over the next five years. Jet injectors are a needleless drug delivery system that distribute a fine jet of medication under such high pressure that it is able to penetrate the skin.

“Needle-free devices have come a long way to the present state and are playing an increasingly important role in the novel drug delivery technology markets,” Kalorama drug delivery analyst Mary Anne Crandall wrote in a report titled Needle-Free Drug Delivery Markets. She predicts that their ease of use, safety and cost effectiveness, combined with evolving technology, will result in a future boom in jet injector sales. Read the full article