Type 1 Diabetes Clinical Trial
Official title:
A Double-blinded, Randomized, Two-way, Cross-over Study to Assess the Efficacy of Small Subcutaneous Glucagon Dose Against the Conventional 1 mg Dose to Treat Hypoglycemia in Adults With Type 1 Diabetes
In the unfortunate case of severe hypoglycaemia, glucagon is the first-line treatment
because of its potent and rapid action starting as fast as 5 minutes after subcutaneous or
intramuscular injection. Large dose of glucagon such as 1 mg subcutaneous is usually
associated with undesirable side-effects such as nausea, vomiting, bloating and headache.
The overall objective of this research proposal is to assess the efficacy of lower
subcutaneous doses of glucagon (0.1 mg or 0.2 mg) to correct hypoglycaemia compared to the
standard dose (1.0 mg) in adults with type 1 diabetes mellitus (T1D).
It is postulated that much lower dosages of glucagon (0.1 or 0.2 mg) injected subcutaneously
will be just as effective as the current recommended dose of 1.0 mg to correct hypoglycaemia
without the undesirable gastro-intestinal side effects.
In the unfortunate case of severe hypoglycaemia, glucagon is the first-line treatment
because of its potent and rapid action starting as fast as 5 minutes after subcutaneous or
intramuscular injection. Current instructions for the treatment of severe hypoglycaemia call
for the immediate injection of 1 mg of glucagon subcutaneously or intramuscularly. Large
dose of glucagon such as 1 mg subcutaneous is usually associated with undesirable
side-effects such as nausea, vomiting, bloating and headache. Moreover, glucagon emergency
kits are relatively expensive (around $100 per kit), thus increasing the financial burden of
diabetes on patients and the health care system.
The primary objective of this research project is to the study the pharmacological effects
of different doses of glucagon injected subcutaneously to correct hypoglycaemia during
controlled conditions mimicking a hypoglycaemic event in adults with type 1 diabetes. More
specifically, we will be looking at the effects of subcutaneous glucagon injected at 0.1 or
0.2 mg and 1.0 mg to normalized plasma glucose during a hypoglycaemic hyperinsulinemic clamp
in subjects with type 1 diabetes.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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