Featured Research

from universities, journals, and other organizations

Is Inhaled Insulin Delivery Still A Possibility? Why Has It Been A Commercial Failure?

Date:
September 23, 2009
Source:
Mary Ann Liebert, Inc./Genetic Engineering News
Summary:
The commercial failure of Exubera, the first inhaled insulin product to come to market, led other companies such as Eli Lilly-Alkermes to halt studies of similar drug delivery in development intended to compete for a share of the lucrative diabetes market. Does this signal defeat for efforts to deliver insulin via the lungs?

The commercial failure of Exubera® (Pfizer, New York, NY), the first inhaled insulin product to come to market, led other companies such as Eli Lilly-Alkermes to halt studies of similar drug delivery in development intended to compete for a share of the lucrative diabetes market. Does this signal defeat for efforts to deliver insulin via the lungs? The science and circumstances behind the Lilly-Alkermes decision to discontinue trials of the AIR® inhaled insulin product are explored in a special supplement to Diabetes Technology & Therapeutics, a peer-reviewed journal published by Mary Ann Liebert, Inc.

Related Articles


The supplement presents the data on AIR inhaled insulin that has been made available by Eli Lilly (Indianapolis, IN) and Alkermes (Cambridge, MA), co-developers of the drug. Eight articles describe various protocols in which the effectiveness and safety of AIR were compared to traditional insulin injections in patients with type 1 or type 2 diabetes. These studies represent noninferiority trials, in which AIR was evaluated for its potential to be at least as safe and effective as subcutaneous (SC) insulin across a range of parameters.

Satish K. Garg, MD, Professor of Medicine and Pediatrics at the University of Colorado Denver, and Editor-in-Chief of Diabetes Technology & Therapeutics, and colleagues report the results of a 2-year Phase 3 trial conducted in 385 patients, in an article entitled, "Two-Year Efficacy and Safety of AIR Inhaled Insulin in Patients with Type 1 Diabetes: An Open-Label Randomized Controlled Trial." The study found AIR to be inferior to SC insulin (in a noninferiority clinical trial design) in its ability to maintain optimal blood glucose levels over time, based on measurements of glycosylated hemoglobin (HbA1c).

Similarly, Angel L. Comulada, MD, FACE, Instituto de Endocrinología, Diabetes & Metabolismo, Toa Baja, Puerto Rico, and coworkers demonstrated inferiority of AIR in their study of 500 patients with type 1 diabetes over 6 months. They report their findings in the article "Efficacy and Safety of AIR Inhaled Insulin Compared to Insulin Lispro in Patients with Type 1 Diabetes Mellitus in a 6-Month, Randomized, Noninferiority Trial."

"The question now remains whether this route of delivering insulin has been exhausted or if it still remains to be explored," write Satish Garg, MD and William Kelly, BS from the University of Colorado Denver in the Editorial "Insulin Delivery via Lungs—Is It Still Possible?" MannKind Corporation recently filed a New Drug Application with the FDA for Technosphere® Insulin. It offers faster onset of action with lower postprandial blood glucose excursions especially in the first two hours and is weight neutral, according to the Editorial.


Story Source:

The above story is based on materials provided by Mary Ann Liebert, Inc./Genetic Engineering News. Note: Materials may be edited for content and length.


Journal References:

  1. Garg et al. Two-Year Efficacy and Safety of AIR Inhaled Insulin in Patients with Type 1 Diabetes: An Open-Label Randomized Controlled Trial. Diabetes Technology & Therapeutics, 2009; 11 (s2): S-5 DOI: 10.1089/dia.2009.0040
  2. Comulada et al. Efficacy and Safety of AIR Inhaled Insulin Compared to Insulin Lispro in Patients with Type 1 Diabetes Mellitus in a 6-Month, Randomized, Noninferiority Trial. Diabetes Technology & Therapeutics, 2009; 11 (s2): S-17 DOI: 10.1089/dia.2009.0041
  3. Satish K. Garg, William C. Kelly. Insulin Delivery via Lungs -- Is It Still Possible? Diabetes Technology & Therapeutics, 2009; 11 (s2): S-1 DOI: 10.1089/dia.2009.0088

Cite This Page:

Mary Ann Liebert, Inc./Genetic Engineering News. "Is Inhaled Insulin Delivery Still A Possibility? Why Has It Been A Commercial Failure?." ScienceDaily. ScienceDaily, 23 September 2009. <www.sciencedaily.com/releases/2009/09/090923121450.htm>.
Mary Ann Liebert, Inc./Genetic Engineering News. (2009, September 23). Is Inhaled Insulin Delivery Still A Possibility? Why Has It Been A Commercial Failure?. ScienceDaily. Retrieved April 18, 2015 from www.sciencedaily.com/releases/2009/09/090923121450.htm
Mary Ann Liebert, Inc./Genetic Engineering News. "Is Inhaled Insulin Delivery Still A Possibility? Why Has It Been A Commercial Failure?." ScienceDaily. www.sciencedaily.com/releases/2009/09/090923121450.htm (accessed April 18, 2015).

Share This


More From ScienceDaily



More Health & Medicine News

Saturday, April 18, 2015

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Our Love Of Puppy Dog Eyes Explained By Science

Our Love Of Puppy Dog Eyes Explained By Science

Newsy (Apr. 17, 2015) — Researchers found a spike in oxytocin occurs in both humans and dogs when they gaze into each other&apos;s eyes. Video provided by Newsy
Powered by NewsLook.com
Scientists Find Link Between Gestational Diabetes And Autism

Scientists Find Link Between Gestational Diabetes And Autism

Newsy (Apr. 17, 2015) — Researchers who analyzed data from over 300,000 kids and their mothers say they&apos;ve found a link between gestational diabetes and autism. Video provided by Newsy
Powered by NewsLook.com
Video Messages Help Reassure Dementia Patients

Video Messages Help Reassure Dementia Patients

AP (Apr. 17, 2015) — Family members are prerecording messages as part of a unique pilot program at the Hebrew Home in New York. The videos are trying to help victims of Alzheimer&apos;s disease and other forms of dementia break through the morning fog of forgetfulness. (April 17) Video provided by AP
Powered by NewsLook.com
Boy or Girl? Intersex Awareness Is on the Rise

Boy or Girl? Intersex Awareness Is on the Rise

AP (Apr. 17, 2015) — At least 1 in 5,000 U.S. babies are born each year with intersex conditions _ ambiguous genitals because of genetic glitches or hormone problems. Secrecy and surgery are common. But some doctors and activists are trying to change things. (April 17) Video provided by AP
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
 
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:  

Breaking News:

Strange & Offbeat Stories

 

Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:  

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile iPhone Android Web
Follow Facebook Twitter Google+
Subscribe RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins