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

Conditions: Type 1 diabetes
MedDRA version: 18.0Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

Registration Number: EUCTR2015-003252-40-Outside-EU/EEA

Lead Sponsor: T1D Exchange Clinic Network Coordinating Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 48

Inclusion Criteria

1. History of type 1 diabetes and receiving daily insulin therapy from the time of diagnosis for at least 12 months.
2.At least 4.0 years of age and less than 17.0 years.
3.Females must meet one of the following criteria:
a) Of childbearing potential but agrees to use an accepted contraceptive regimen as described in the study procedure manual throughout the entire duration of the study (from the screening visit until study completion).
or
b) Of non-childbearing potential, defined as a female who has had a hysterectomy or tubal ligation, is clinically considered infertile or has not yet reached menarche.
4. In good general health with no conditions that could influence the outcome of the trial, and in the judgment of the Investigator is a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations.
5. Willingness to adhere to the protocol requirements

Are the trial subjects under 18? yes
Number of subjects for this age range: 48
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Females who are pregnant according to a positive urine pregnancy test, actively attempting to get pregnant, or are lactating.
2.History of hypersensitivity to glucagon or any related products or severe hypersensitivity reactions (such as angioedema) to any drugs.
3.Presence of cardiovascular, gastrointestinal, liver or kidney disease, or any other conditions which in the judgment of the investigator could interfere with the absorption, distribution, metabolism or excretion of drugs or could potentiate or predispose to undesired effects.
4.History of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma.
5.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.
6.Use of daily systemic beta-blocker, indomethacin, warfarin or anticholinergic drugs.
7.History of epilepsy or seizure disorder.
8.Use of an Investigational Product in another clinical trial within the past 30 days
9.Blood donation in 3 months prior to first glucagon dosing visit.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the pharmacokinetics and pharmacodynamics of glucagon administered intranasally in comparison with commercially-available intramuscular glucagon;Secondary Objective: Safety and tolerability of intranasal glucagon will be evaluated.;Primary end point(s): PK/PD relationship as measured by blood levels of glucagon and glucose following glucagon administration.;Timepoint(s) of evaluation of this end point: 90 minutes

Secondary Outcome Measures