Efficacy of Small Subcutaneous Glucagon Dose to Treat Hypoglycemia in Adults With Type 1 Diabetes

• Status: Withdrawn
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut de Recherches Cliniques de Montreal
• Collaborator: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
• Treatments: Glucagon; Glucagon-Like Peptide 1; Hypoglycemic Agents

Criteria

Inclusion Criteria:

• Males and females ≥ 18 years of old

• Clinical diagnosis of type 1 diabetes for at least two years.

Exclusion Criteria:

• Clinically significant nephropathy (MDRD < 60 mL/min/1.73 m2).

• Pregnancy

• Severe hypoglycemic episode within two weeks of screening

• Current use of glucocorticoid medication (except low stable dose)

• Pheochromocytoma or primary adrenal insufficiency (e.g. Addison's disease)

• Medical condition likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.