New therapy to fight pediatric hypoglycemia

For parents of a child with type 1 diabetes (T1D), hypoglycemia can be a scary-and fatal-complication, but a treatment is in development that gives parents and caregivers a new way to keep glucose levels in check.

Hypoglycemia occurs when blood glucose levels fall below 70 mg/dL. In patients with T1D, keeping blood glucose in check through diet, exercise, and insulin therapy can be complicated because patients with T1D have an autoimmune disorder that attacks the pancreas and prevents it from creating insulin. Without insulin, which carries glucose into the cell for nourishment, glucose remains in the blood stream and can build up to dangerous levels. With insulin therapy, however, T1D patients may experience an insulin reaction as well as low blood glucose levels. When blood glucose levels drop, the patient may not even be aware he or she is hypoglycemic, and often the person will lose consciousness.

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About 1.25 million Americans live with T1D, including about 200,000 persons aged younger than 20 years, which is why T1D was previously referred to as juvenile diabetes. According to the Juvenile Diabetes Research Foundation (JDRF), there was a 21% surge in T1D prevalence in persons younger than 20 years from 2001 to 2009, and 40,000 new diagnoses are made each year.

Less than a third of patients with T1D aren’t achieving adequate blood glucose control, says JDRF, and the disease is associated with reducing life expectancy by an estimated 13 years. Of those living with T1D diabetes or other forms of the disease, the American Diabetes Association (ADA) says hypoglycemia was listed as the primary medical diagnosis in nearly 300,000 emergency department visits for adults during 2011.

In the hospital setting, patients in this state are given intravenous (IV) glucagon-a hormone that directs the liver to release glucose into the blood stream. For parents and caregivers outside the hospital, glucagon is available as an intramuscular (IM) injection.

The administration of the injection can be tricky, however, especially when adrenaline and anxiety come into play. Seeing a child unconscious can be very jarring, particularly for loved ones who are often counted on for emergency care. Those caregivers then must be able to reconstitute the glucagon medication and inject it into the patient with a syringe-and this must be done quickly.

A new formulation of glucagon-intranasal (IN) powder-may prove beneficial in many ways, according to research recently presented at a poster session at the ADA’s 75th Scientific Sessions held in June in Boston.

Jennifer Sherr, MD, PhD, lead author of the study and assistant professor of pediatrics at the Yale School of Medicine, New Haven, Connecticut says the IN formulation-from Locemia Solutions- could reduce the amount of valuable time it takes parents and caregivers to provide life-saving treatment during severe hypoglycemic episodes.

“There been some studies where parents were given a wrapped piece of meat and simulated situation, and it took them 2 minutes and 30 seconds to give an injection,” Sherr says. “Yes, we’re all ‘trained’ on it, but when you’re in the moment, anxiety kicks in.”

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The powdered glucagon would be made available in a single-use device that releases the medication into the patient’s nose. Sherr says the IN powder does not need to be inhaled. Rather, it enters the bloodstream through passive absorption via the nasal membrane. The fact that the device is ready to use, without the requirement of mixing or reformulating, adds to its benefit, she says.

In Sherr’s study, children aged 4 to 12 years were given either 1 IM dose of 1 mg of glucagon or 2 IN doses of either 2 mg or 3 mg each. The glucagon was given 5 minutes after blood glucose levels dropped below 80 mg/dL, according to Sherr’s poster data. This resulted in an increase in blood glucose of 25 mg/dL or more within 20 minutes in all patients that received IN glucagon, except for 1 participant who blew his nose immediately after administration.

Sherr says the fact that a 3-mg dose of the IN power was effective across the entire pediatric population in her study is also a bonus because it takes away confusion for pediatricians in prescribing these medications. A single-dose product would also reduce the possibility of error in frantic caregivers who don’t have to worry about what size dose they are grabbing, Sherr adds. “I think that’s going to be a huge benefit for both prescribers and parents,” she says.

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In terms of adverse effects, 42% of IN glucagon recipients experienced nausea compared with 67% of IM glucagon recipients.

Sherr adds that the IN glucagon would be possible to administer while a patient is seizing, and would certainly be no more difficult than administering an injection to a patient experiencing a seizure. “This study basically showed that this formulation of glucagon is both safe and effective in the pediatric population and works very similarly to raising glucose [as traditional methods],” Sherr says.

Study results have not yet been published.

Phase 3 trial results from an IN glucagon study in adults were presented this past spring at the Advanced Technologies & Treatments for Diabetes (ATTD) conference in Paris. Researchers revealed at the conference that this new formulation would be the first-ever need-free form of glucagon.

Although the adult trials indicated that the IN glucagon was about 5 minutes slower in raising blood glucose than the IM formulation, Sherr says those results were not consistent in the pediatric trials she conducted. In fact, no lag time was noted in the trial involving children and adolescents, she says.

This spring, reports were circulating that Locemia could be introduced to market in late 2016 or early 2017, but Sherr wasn’t certain of the company’s progress with the US Food and Drug Administration (FDA). Locemia states on its website that it plans to submit its IN glucagon to the FDA by late 2015 and anticipates approval by late 2016.

The pediatric trial was funded principally by The Leona M. and Harry B. Helmsley Charitable Trust, with additional support from Locemia Solutions.