New Ultra Long Acting Insulin Could End the Need for Daily Injections

February 18th, 2011

insulin syringe

Danish pharmaceutical giant Novo Nordisk has completed clinical testing of a new generation of ultra long acting insulin, called insulin degludec. More than 10,000 type 1 and type 2 diabetics from 40 different countries participated in 17 different trials.

Trial results consistently showed Degludec to be as effective in lowering blood sugar as the current most widely used long acting insulin, Sanofi-Aventis' Lantus (insulin glargine), with no difference in adverse effects.

More importantly, trial participants given Degludec experienced significantly fewer episodes of hypoglycemia than those given Lantus, especially potentially dangerous night time hypoglycemia. Trials with type 2 diabetics saw a decrease in nighttime hypoglycemia of over 35 percent, and trials with type 1 diabetics of 40 percent.

Degludec is effective for up to 40 hours, roughly twice as long as insulin glargine. Lantus is said to be effective for 18 to 26 hours, although some users report a shorter efficacy. The only other long acting insulin on the market, Novo Nordisk's Levemir (insulin detemir), has a similar action period. Like Lantus and Levemir, Degludic's action is flat, without pronounced peaks in effectiveness.

The new insulin is released so slowly and steadily into the body that it may allow some diabetics to go from daily injections to just three injections a week. Degludic's long and steady action is attributable to the fact it forms a "depot" of soluble multi-hexamers when injected under the skin, from which the insulin is slowly and steadily absorbed into the body.

At the same time, Novo Nordisk is also developing Degludec Plus, the first combination of a long acting insulin (or basal insulin) with a rapid acting (or bolus) insulin, insulin aspart. Until now, it hasn't been possible to combine a basal insulin and a bolus insulin in one single injection.

Lantus (insulin glargine) currently leads the market, generating sales of almost $4 billion a year globally. Levemir (insulin detemir) lags far behind in sales. Now that the phase 3 trials have been completed, Novo Nordisk will be seeking FDA approval for both Degludec and Degludec Plus in 2011, and hopes to begin marketing the new diabetes medications in 2013. Degludec is expected to be marketed at a higher price than Lantus, because of its reduced incidence of hypoglycemia and potential need for less frequent insulin injections.

For more information on Degludec and Degludec Plus, click this Global Medical News video link.

Consider an Online Canadian Pharmacy When You Buy Lantus

June 30th, 2011

Lantus is a popular basal, or long acting, insulin used in the treatment of both type 1 and type 1 diabetes mellitus. The diabetes medication is suitable for both adult and pediatric patients with Type 1 diabetes, and for adults with Type 2 diabetes who require long-acting insulin injections to control hyperglycemia.

Lantus long acting insulin has some key benefits: it is used only once daily, it has no pronounced peak; it lowers basal glucose levels for a full 24 hours; and it can be used with oral diabetes medications and/or short-acting insulin for better diabetes control. One of the biggest advantages of Lantus is that, due to its lack of peak, it decreases the risk of nocturnal hypoglycemia.

Lantus (insulin glargine), marketed by Sanofi-Aventis, currently leads the long acting insulin market, generating sales of almost $4 billion a year globally. Lantus is available in both conventional vials and the discreet and convenient pre-filled Lantus SoloSTAR insulin pen.

Many diabetics help manage the cost of daily insulin injections by buying their diabetes medication from a Canadian online pharmacy. The Canadian government regulates prescription drug prices, and does not allow pharmaceutical companies to engage in expensive direct to consumer marketing, helping to keep drug prices lower.

The Canadian government also allows drug companies to manufacturer cheaper (but chemically identical) generic versions of brand name drugs sooner than in the States. Canadian pharmacies are anticipating they will be able to provide their customers with affordable generic Lantus in the near future, so revisit for updates.

It is not uncommon for a prescription purchased through a Canadian online pharmacy to be 50% cheaper than one purchased in the US, and not unheard of for it to be up to 90% cheaper. To buy Janumet online from a Canadian pharmacy, you must have a current valid prescription.

Be sure you are dealing with a reputable online Canada pharmacy by ensuring it does not offer drugs without a prescription, does not sell controlled substances such as narcotics, has clear contact information including a physical address, has a licensed pharmacist available to answer questions, and is accredited by the Canadian International Pharmacy Association.

Like all types of insulin, Lantus is only part of a complete program of diabetes treatment that may also include diet, exercise, weight control, and regular blood sugar monitoring. Any decisions about your diabetes medication should be made together with your doctor or another health care professional.

Mealtime Insulin Injections May be Replaced by an Insulin Inhaler

August 12th, 2011

There's good news for insulin dependent diabetics who rely on fast-acting mealtime insulin injections to keep their blood sugar under control. MannKind Corporation has the go-ahead to continue clinical testing of its investigational inhaled insulin, AFREZZA. The drug maker and the FDA met to confirm the protocols for two new studies, one in type 1 diabetics, and one in type 2 diabetics.

AFREZZA is an ultra-rapid acting inhaled insulin which uses patented technology to deliver powdered insulin from a thumb-sized device into the lungs. The lungs are an effective option for delivering diabetes medication, largely because of their huge surface area (about the size of a tennis court).MannKind focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes and cancer. Now in late stage clinical investigation, AFREEZA is its lead product candidate. Shares of the company jumped 20% at the news that the design of the follow-up clinical trials had been confirmed.

MannKind has been seeking approval for its new generation diabetes medication since March of 2009, but was asked twice to run additional clinical trials in order to provide the FDA with more information. One of the approval delays was due to the drug maker updating the design of its insulin inhaler after applying for approval of the earlier design. The FDA was concerned that there was not enough data to support a switch to the new generation device, and asked that both models be tested together.

Clinical trials of the initial design of the insulin inhaler were promising. Participants reported being pleased with the innovative insulin delivery device, and experienced less hypoglycemia and weight gain than did controls using a standard combination of long-acting insulin glargine and twice a day 70 30 insulin injections.

Insulin can't be taken orally, as digestive juices break it down before it can be used by the body. Currently, the only means of delivering insulin are subcutaneous insulin injections or intravenously. Because AFREEZA is a short-acting mealtime insulin, type 1 diabetics will need to combine it with long-acting insulin injections for complete diabetes control.

Dr. Larry Deeb, a pediatric endocrinologist from the University of Florida College of Medicine, says that failure to comply with regular insulin dosing is one of the major issues in diabetes, often because of the discomfort and inconvenience of insulin injections. Deeb says that finding an alternative insulin delivery method is crucial, especially for children and the needle-phobic.

Should it be approved, AFREEZA would be the second inhaled insulin to hit the market. Pfizer received approval to market a similar product, Exubera, several years ago, but, surprisingly, the product never caught on with diabetics, and was withdrawn from the market a year later.

AFREZZA is easier to use, faster acting and boasts better bioavailability than Exubera, enabling diabetics to achieve more satisfactory insulin levels using smaller amounts. Despite Exubera's unexpected failure, AFREEZA is expected to be a blockbuster diabetes drug when it becomes available.

Does Using Long Acting Insulin Increase Cancer Risk?

September 6th, 2011

long acting insulin

According to the FDA, five recent studies of a possible link between insulin glargine (marketed as Lantus long acting insulin) and the growth of cancerous cells have failed to shed more light on the subject. Calling the studies "inconclusive", the FDA said it was continuing to work with the long acting insulin manufacturer, Sanofi-Aventus, to determine whether there is an increased risk of cancer for users of insulin glargine.

The concerns arose because Lantus' ability to act as a long acting insulin arises from its prolonged interaction with the insulin-like growth factor-I receptor (IGF-IR). IGF-IR overactivity has been linked to many types of cancer. That begs the question - could long acting insulin glargine be associated with cancer because of its continual interfacing with IGF-IR?

While the debate about the possible cancer risk associated with long acting insulin continues, the American Diabetes Association, the American Association of Clinical Endocrinologists and two similar European governing bodies are reassuring insulin dependent diabetics that there is no need to change their insulin glargine treatment.

To read more about the controversial long-acting Lantus insulin clinical studies on, >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.