Assessment of Intranasal Glucagon in Children and Adolescents With Type 1 Diabetes

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to assess how glucagon administered nasally, using a nasal dosing delivery device, works in children and adolescents compared with commercially-available glucagon given by injection. In addition, the safety and tolerability of glucagon given nasally was evaluated.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company; Jaeb Center for Health Research
• Collaborators: Jaeb Center for Health Research; Locemia Solutions ULC
• Treatments: Glucagon; Glucagon-Like Peptide 1

Criteria

Inclusion Criteria:

To be eligible, the following inclusion criteria were met:

• History of type 1 diabetes and receiving daily insulin therapy from the time of diagnosis for at least 12 months

• At least 4 years of age and less than 17 years

• Females must have met one of the following criteria:

• Of childbearing potential but agreed to use an accepted contraceptive regimen as described in the study procedure manual throughout the entire duration of the study (from screening until study completion)

• Of non-childbearing potential, defined as a female who had a hysterectomy or tubal ligation, was clinically considered infertile or had not yet reached menarche

• In good general health with no conditions that could have influenced the outcome of the trial, and in the judgment of the Investigator was a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations

• Willingness to adhere to the study requirements

Exclusion Criteria:

An individual was not eligible if any of the following exclusion criteria were present:

• Females who were pregnant according to a positive urine pregnancy test, actively attempting to get pregnant, or were lactating

• History of hypersensitivity to glucagon or any related products or severe hypersensitivity reactions (such as angioedema) to any drugs

• Presence of cardiovascular, gastrointestinal, liver or kidney disease, or any other conditions which in the judgment of the investigator could have interfered with the absorption, distribution, metabolism or excretion of drugs or could potentiate or predispose to undesired effects

• History of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma

• History of an episode of severe hypoglycemia (as defined by an episode that required third party assistance for treatment) in the 1 month prior to enrolling in the study

• Use of daily systemic beta-blocker, indomethacin, warfarin or anticholinergic drugs

• History of epilepsy or seizure disorder

• Use of an Investigational Product in another clinical trial within the past 30 days

• Blood donation in 3 months prior to first glucagon dosing