As per my usual practice, I receive information and comments from my patients, colleagues, and readers. I received the following exciting news from one of my diabetes team members and wanted to pass along the latest information available.
Studies regarding intranasal glucagon are not new, and we now have the ability to treat multiple serious conditions with intranasal medications. The latest and most publicized of these is Naloxone. Naloxone is the medication used to treat opiate (heroin, etc.) overdoses and is generally given intravenously or intramuscularly (IM). The medication is lifesaving, reversing overdoses very quickly. As we in the diabetes world know, glucagon injection is also lifesaving in the face of neurogenic hypoglycemia (coma or seizures) as it increases blood sugar by metabolizing stored glycogen into glucose in the liver.
In a paper published by Pontiroli and Associates in Diabetes Care Volume 12, Number 9, October, 1989, intranasal glucagon was studied in a control group of medical students without diabetes and an experimental group of 45 patients with type 1 diabetes. It was known at the time that intranasal glucagon could raise blood glucose levels in healthy subjects, and the aim of the study was to compare the rise in blood glucose in non-diabetic subjects and those with type 1 diabetes. The study was also to test the efficacy of intranasal and IM glucagon in raising blood sugars in hypoglycemic situations for insulin-treated patients. The results indicated that intranasal glucagon raised blood sugar levels in both non-diabetic and patients with type 1 diabetes. The effect of IM glucagon was similar for the first 30 minutes and higher thereafter. Intranasal glucagon was also quicker-acting than oral glucose in non-diabetic subjects and raised blood glucose levels in patients with hypoglycemic episodes, but it did this less effectively than IM glucagon. The current standard of practice is subcutaneous administration of glucagon in the home setting.
The National Institutes of Health (NIH) study, “Effectiveness and Safety of Intranasal Glucagon for Treatment of Hypoglycemia in Adults” (NCT01004746) is currently recruiting participants. According to the ClinicalTrials.gov website, “the primary objective of the study is to assess the effectiveness and safety of 3 mg glucagon (AMG504-1) administered as a puff in the nose as compared with commercially–available glucagon by injection.” It is an interventional, safety/efficacy study with crossover assignment and is an open label study (people know what they are receiving).
The study began in November 2013, and the estimated enrollment is 82 adult subjects with the estimated completed date of May 2014.
Inclusion criteria, according to the study:
• Either type 1 diabetes patients receiving daily insulin since time of diagnosis for two years or type 2 diabetes patients receiving daily insulin for two years
• 18 years to 65 years old
• BMI greater than or equal to 20 and less than or equal to 35.2
• Minimum weight of 50 kg
• Women, if of childbearing age, must agree to use contraception throughout the duration of the study or, if not of childbearing age, infertile either by hysterectomy, tubal ligation, or menopause
• In good general health, based on medical history
• Willingness to adhere to protocol requirements
There is also an extensive exclusion criteria including, but not limited to, pregnancy; hypersensitivity to glucagon or related products; and presence of cardiovascular, gastrointestinal, liver, or kidney disease that could interfere with absorption, distribution, or metabolism excretion of the drug.
Outcome measures include:
• Increase in plasma blood sugar greater than or equal to 70 mg/dl or an increase of 20 mg/dl or more within 30 minutes of receiving glucagon without receiving additional treatment such of oral of IV glucose or additional glucagon.
• Nasal and non-nasal symptoms such as runny nose, nasal congestion, itching, and sneezing will be assessed at 15-, 30-, 60-, and 90-minute intervals following administration of glucagon
• Recovery from symptoms of hypoglycemia documented by questionnaire when blood sugars reach less than 75 mg/dl at 15-, 30-, 60-, and 90-minute intervals
• Recovery from clinical symptoms of hypoglycemia documented by questionnaire at same intervals above when blood sugar reaches less than 75 mg/dl
• Time from glucagon administration to return of plasma glucose higher than or equal to 70mg/dl
• Additional statistical information
Locations of the study include:
• Barbara Davis Center for Diabetes, Denver, Colorado
• Yale University, New Haven, Connecticut
• University of Florida, Gainesville, Florida
• Riley Hospital for Children at Indiana University Health, Indianapolis, Indiana
• Joslin Diabetes Center, Boston, Massachusetts
• University of Massachusetts, Worcester, Massachusetts
• University of Minnesota, Minneapolis, Minnesota
• University of Buffalo, Buffalo, New York
• Oregon Health and Science University, Portland, Oregon
• University of Pennsylvania, Philadelphia, Pennsylvania
I will keep you posted with the results of this safety and efficacy study as well as when the next phase of the study includes children.
Published On: May 22, 2014