A Sweet Life » Insulin & Pumps

Wireless CGM Sensor – A Milestone on the Way to an Artificial Pancreas

A Sweet Life Staff — Wed, 28 Jul 2010 20:39:47 +0000

Researchers from the University of California San Diego and GlySens Inc. have developed an implantable sensor that measures blood sugar continuously and transmits the information without wires, according to a Reuters report .
The device worked in one pig for more than a year and in another for nearly 10 months with no trouble, and the researchers hope to start a human study within a few months.
The project funded partly by JDRF is part of the Artificial Pancreas Project which aims to develop an automated insulin delivery system based on real-time changes in blood sugar levels.

FDA Accepts AFREZZA Complete Response Resubmission and Sets Target Action Date

A Sweet Life Staff — Tue, 20 Jul 2010 13:28:20 +0000

MannKind Corporation announced that it has submitted, and the U.S. Food and Drug Administration (FDA) has accepted, MannKind’s resubmission of its New Drug Application (NDA) for AFREZZA(TM) (insulin human [rDNA origin]) and classified it as a Class 2 resubmission. With the Class 2 designation, the FDA set a corresponding Prescription Drug User Fee Act (PDUFA) action date of December 29, 2010.

In March 2010, MannKind received a Complete Response letter to its NDA for AFREZZA from the FDA requesting additional information. In response, MannKind has submitted clinical data from a recently completed efficacy study in patients with type 1 diabetes as well as updated pooled safety data related to AFREZZA and information on the comparability of MannKind’s next-generation delivery system to the device that was used in pivotal clinical studies.

“We have worked diligently since March to prepare our resubmission and we are confident that we have addressed the requests that were outlined by the FDA,” said Alfred Mann, Chairman and Chief Executive Officer. “We will continue to work closely with the FDA during this final stage of the review process. We firmly believe AFREZZA has the potential to address a poorly-met need in diabetes therapy. Our primary goal is to make this novel therapeutic option available to patients as soon as possible.”

Biodel Reports Progress in Development of Glucose-Regulated ‘Smart’ Basal Insulin

A Sweet Life Staff — Tue, 13 Jul 2010 13:48:49 +0000

Biodel Inc. reported results of preclinical tests which demonstrated the potential of the company’s glucose-regulated or “smart” basal insulin product candidate, BIOD620, to release insulin proportionally in response to changing glucose conditions. In an oral presentation today at the 37th Annual Meeting and Exposition of the Controlled Release Society in Portland, Oregon, Nandini Kashyap, director of novel drug delivery at Biodel, described results of in vitro and in vivo studies with diabetic pigs which compared the use of BIOD620 to Lantus(R) (insulin glargine). BIOD620 is Biodel’s proprietary injectable formulation of insulin glargine that has been designed to alter its insulin release profile in response to changing glucose concentration.
Six fasted diabetic pigs received a subcutaneous injection of 0.25U/kg of BIOD620 or Lantus(R). Their blood glucose was monitored every 15 minutes. Six hours after receiving their initial injection, they were fed 500 grams of food as a glucose challenge. BIOD620 was able to reduce the elevated plasma glucose levels faster than the group receiving Lantus(R). Furthermore, post-meal hyperglycemia was reduced more rapidly in the BIOD620 group than in the control group.
Dr. Solomon Steiner, chief scientific officer of Biodel, commented: “We are excited about these results because they suggest we have developed a new form of basal insulin that adjusts automatically to changing glucose levels.”

JDRF Grants $407,000 to Evaluate Use of Biodel’s VIAject(R) in Treatment of Diabetes

A Sweet Life Staff — Mon, 12 Jul 2010 15:34:27 +0000

Biodel Inc. announced the award of two research grants by the Juvenile Diabetes Research Foundation (JDRF) to Stanford University and Oregon Health & Science University (OHSU) to evaluate the use of VIAject(R) (ultra-rapid-acting injectable human insulin) in the treatment of diabetes. The first grant will support clinical testing under the direction of Bruce Buckingham, M.D., professor of pediatrics at Stanford University School of Medicine, to compare the effects of VIAject(R) and Humalog(R) (insulin lispro) on postprandial glycemia when used with insulin pumps. The second grant will support clinical testing at OHSU under the direction of W. Kenneth Ward, M.D., associate professor at OHSU, to evaluate the use of VIAject(R) to improve closed-loop, (artificial pancreas) glycemic control in patients with Type 1 diabetes. Biodel will supply VIAject(R) to these institutions which will receive a total of approximately $407,000 from JDRF to fund the two research projects over the next year.
VIAject(R) is Biodel’s proprietary ultra-rapid-acting formulation of recombinant human insulin that is designed to be absorbed into the blood faster than currently marketed rapid-acting insulin analogs. It has been tested in more than 875 patients who participated in Phase 1, 2 and 3 clinical trials of the drug in the United States, Germany and India. Biodel has submitted an application to the U.S. Food and Drug Administration for clearance to market VIAject(R) for the treatment of diabetes.

Novo Nordisk Presents Positive Phase 2 Data for Ultra-Long-Acting Insulin Degludec

A Sweet Life Staff — Sat, 26 Jun 2010 08:33:05 +0000

According to a Novo Nordisk press release the company presented phase 2 proof-of-concept data for its investigational insulin degludec, an ultra-long-acting basal insulin, which demonstrated the potential to help achieve target glycemic control when used once daily or three times weekly. These data were presented at the 70^th Scientific Sessions of the American Diabetes Association (ADA) in Orlando FL.

These phase 2 studies showed that insulin degludec helped improve glucose control.In one study, after 16 weeks of treatment with insulin degludec, mean HbA_1creductions were similar across the once-daily and three-times-weekly insulin degludec groups (-1.3% and -1.5% respectively) and comparable to insulin glargine (-1.5%).

In this study, 77% of patients treated with insulin degludec three times weekly did not experience any confirmed hypoglycemia.

Eli Lilly and Walmart to Provide Affordable Insulin

A Sweet Life Staff — Tue, 22 Jun 2010 15:52:08 +0000

Eli Lilly and Company announced they’re teaming up with Walmart to provide an affordable insulin option for people with diabetes.
Beginning in mid-September, Lilly’s Humulin(R) brand of insulin will be available in Walmart pharmacies across the U.S. under the dual-branded name Humulin(R) ReliOn(R), including 10 mL vials of Humulin(R) R U-100, Humulin(R) N, and Humulin(R) 70/30 formulations.

Humulin, the world’s first synthetic human insulin, was introduced by Lilly in 1982.

Oral Insulin AFREZZA Successful at Controlling Blood Sugar Levels in Type 1 Diabetes Patients

A Sweet Life Staff — Thu, 10 Jun 2010 16:32:14 +0000

MannKind announced that results of a new 16-week trial show that the investigational ultra rapid acting mealtime insulin, AFREZZA (insulin human [rDNA origin]) Inhalation Powder, combined with basal insulin, is clearly non-inferior to standard therapy insulin lispro, a rapid acting insulin (also combined with basal insulin), in reducing HbA1c levels in subjects with inadequately controlled type 1 diabetes. In addition, patients treated with AFREZZA had statistically significant lower rates of hypoglycemia, post-prandial glucose levels when measured at 30, 60, 90 and 120 minutes, and fasting blood glucose levels when compared to subcutaneously injected insulin lispro.

Children with Diabetes in California Schools: ADA Issues Statement

A Sweet Life Staff — Thu, 10 Jun 2010 06:30:17 +0000

The American Diabetes Association (ADA) issued a statement expressing extreme disappointment in the California Court of Appeal ruling in the case of American Nurses Association et al. v. O’Connell, which prevents non-medical school personnel from volunteering to administer insulin to California schoolchildren who are not yet able to self-manage their disease.
The ADA said children with diabetes are in danger as a result of this ruling, because there are not enough nurses or other licensed health care professionals available in California’s schools to administer the insulin that young students with diabetes must have in order to be safe at school.

Where Have You Flexed?

A Sweet Life Staff — Mon, 03 May 2010 19:11:27 +0000

Novo Nordisk has announced an online insulin pen photo contest. The “Where Have You Flexed?” contest asks people who use the FlexPen to submit photos of themselves with their pen in unique locations. The grand prize winner will receive a trip for two to the Firestone Indy Lights championship in Miami on October 2 to see Charlie Kimball (the first licensed racer with diabetes) race. Second and third place submissions win exercise equipment.

Winners will be determined by a panel of judges, as well as votes from the public. Anyone (with or without diabetes) can vote on the photos for a chance to win one of five iPod Touches.

See the full press release here: http://multivu.prnewswire.com/mnr/novonordisk/43828/

Study Shows AFREZZA Safe and Effective in Controlling Blood Glucose Levels

A Sweet Life Staff — Sat, 24 Apr 2010 11:09:34 +0000

MannKind Corp. announced the results of a two year study comparing the efficacy and safety of AFREZZA (insulin human [rDNA origin]) versus usual diabetes care.

The study followed patients for a total of up to two years. The patients were randomly assigned to a treatment regimen of either AFREZZA plus subcutaneous basal insulin or usual diabetes treatment regimens of any insulin. At the end of two years, there was a comparable reduction in HbA_1c levels (by 0.29% and 0.31% in the AFREZZA and usual care groups, respectively). Additionally, AFREZZA resulted in weight loss, while standard diabetes care resulted in weight gain (-0.59 versus +1.38kg, respectively; p=0.0007). There was a lower incidence of hypoglycemic events in the AFREZZA group (61.8% versus 66.05% for the usual care group).

AFREZZA is a novel, ultra rapid acting mealtime insulin therapy being developed by MannKind Corporation for the treatment of adult patients with Type 1 and Type 2 diabetes for the control of hyperglycemia. It is a drug-device combination product, consisting of AFREZZA Inhalation Powder