Exubera May Eliminate or Reduce Need For Insulin Injections

A new form of insulin that is administered through an inhaler and absorbed through the lungs is being tested by a team at UMDNJ-Robert Wood Johnson Medical School (RWJMS) as part of a nationwide clinical trial. The inhaled insulin–called Exubera–is being studied as a replacement for standard insulin injections in people with Type 2 diabetes.

“Exubera is administered by an inhaler device similar to those used by asthmatic patients,” explains Stephen H. Schneider, MD, professor of medicine at RWJMS and the trial’s principal investigator. “The inhaler is loaded with medicated pellets that then are converted by the inhaler into a mist spray for application.”

Initially, many patients with Type 2 diabetes can be controlled by one or more oral medications, such as Metformin, according to Schneider. “But with continued progression of the disease, patients eventually require either a third medication or insulin injections because beta cells in the pancreas die,” he says. Uncontrolled diabetes is the primary cause of kidney failure, blindness and amputation, and is the leading risk factor for premature coronary artery disease.

Schneider says the drug has been tested in clinical trials for four to 12 weeks, but participants in this trial will take it for a year. The purpose is to determine if patients experience any pulmonary complications related to long-term use. He says participants will be closely monitored, and the study will be halted if patients experience related lung problems.

Exubera was developed as a joint venture by Pfizer and Aventis in conjunction with Nektar Therapeutics, designers of the inhalation technology. The medical school is one of 60 sites nationwide participating in the Phase 3, 52-week study.

Some 16 million Americans have diabetes. Those with Type 2 produce varying levels of insulin, the hormone that controls blood sugar levels, and often do not require daily insulin. Those with Type 1 require daily insulin injections because no insulin is produced by the body.

Individuals in the study must have Type 2 diabetes, be age 18 to 80, non-smokers and not currently taking insulin injections. In addition, their diabetes must be inadequately controlled by two oral medications. Participants will be required to inhale one mist prior to each meal. For further information about the study, call 732-235-7751.