This trial is comparing the effectiveness of G-Pen (Glucagon Injection) to GlucaGen® Hypokit® (Glucagon) in the treatment of hypoglycemia in patients with type 1 diabetes (T1D). The main outcome to be measured is the number of patients with an increase in blood sugar levels within 30 minutes after rescue medication.
The details
The main treatment of T1D is insulin (the hormone that lowers blood sugar). However, the risk of insulin therapy is causing blood sugar levels to go dangerously low (hypoglycemia). Hypoglycaemia needs to be treated urgently with glucagon (a hormone that increases blood sugar levels).
G-Pen is a new ready to use glucagon injection pen to treat hypoglycemia. GlucaGen Hypokit is a glucagon rescue kit that consists of a vial of glucagon and a syringe with sterile water. The glucagon in the GlucaGen Hypokit needs to be drawn up into the syringe before it can be injected.
The purpose of this study is to compare the effectiveness of the G-Pen compared to the GlucaGen Hypokit (Novo Glucagon) in the treatment of hypoglycemia. The main outcome to be measured is the number of subjects with an increase in blood sugar levels from below 3mmol/L to 3.89 mmol/L or an increase in blood sugar to more than 11.1 mmol/L within 30 minutes of receiving glucagon.
Who are they looking for?
This study is recruiting 122 patients. Patients must have had T1D for at least 24 months and have a C-peptide of less than 0.6 ng/mL. Patients must provide consent and be willing to participate in all study procedures.
Patients must not have a HbA1c level of above 10%, have liver enzymes 3 times the upper limit of normal or low blood protein levels. Patients must not have anemia or inadequate (lower than 90/50mmHg or greater than 150/100mmHg) blood pressure readings. The must not have electrocardiogram (ECG) abnormalities, a total insulin dose of greater than 2 units per kilogram or have non-accessible veins. Patients must not have heart failure or have had a heart attack, stroke or unstable angina or any procedures on their heart in the past 6 months. They must not have had cancer in the past 5 years, surgery in the past 30 days or a seizure disorder of any kind. Patients must not have a bleeding disorder or be taking blood thinners. Patients must not have taken glucagon within 7 days or be involved in any other studies in the last 30 days.
How will it work
Patients will visit the clinical research center twice. They will be randomly assigned to receive G-Pen glucagon 1 mg during one period and Novo Glucagon 1 mg during the other period. Patients will stay overnight in the center the night before and be brought into hypoglycemia by being given insulin through a vein. When patients are in hypoglycemia, they will be given either G-pen or Glucagon by injection. Blood sugar levels will be monitored for 180 minutes after. After 3 hours, patients will be given a meal and discharged when medically stable. After 7 -28 days, patients will return to the research center and the procedure will be repeated with the patient receiving the other treatment. A follow-up safety check is done 2-7 days after the final dose of the drug.
