Phase 3
Completed N=48
Assessment of Intranasal Glucagon in Children and Adolescents With Type 1 Diabetes
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT01997411 ↗
Enrolled (actual)
48
Serious AEs
1.2%
Results posted
Mar 2017
Primary outcomePrimary: Maximum Change From Baseline Concentration (Cmax) of Glucagon — 6290.33; 3463.55; 3958.58; 4743.00 picograms per millilitre (pg/mL)
◆ Published Evidence
Highly cited
121citations · ~12 / year
Glucagon Nasal Powder: A Promising Alternative to Intramuscular Glucagon in Youth With Type 1 Diabetes.
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.
Linked Publications
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Glucagon Nasal Powder: A Promising Alternative to Intramuscular Glucagon in Youth With Type 1 Diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Change From Baseline Concentration (Cmax) of Glucagon |
6290.33; 3463.55; 3958.58; 4743.00; 2776.27; 5664.33 | — |
| PRIMARY Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon |
0.29; 0.25; 0.29; 0.29; 0.25; 0.25 | — |
| PRIMARY Area Under the Curve (AUC0-1.5) of Baseline Adjusted Glucagon |
4078.68; 1744.36; 2472.40; 3635.77; 1506.23; 2939.31 | — |
| PRIMARY Maximum Concentration (Cmax) of Baseline-Adjusted Glucose |
138.17; 118.18; 137.50; 130.50; 125.09; 132.82 | — |
| PRIMARY Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose |
1.00; 0.67; 1.00; 1.50; 1.00; 1.00 | — |
| PRIMARY Area Under the Effect Concentration Time Curve (AUEC0-1.5) of Baseline-Adjusted Glucose From Time Zero up to 90 Minutes |
145.86; 118.82; 142.38; 132.42; 128.82; 138.12 | — |
| SECONDARY Nasal and Non-nasal Effects/Symptoms |
0.50; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Number of Participants Achieving at Least a 25 mg/dL Rise in Blood Glucose Above Nadir Level Within 30 Minutes |
6; 11; 12; 6; 11; 12 | — |
| SECONDARY Time to Achieving ≥25 mg/dL Rise in Plasma Glucose Above Nadir Level Within 30 Minutes |
10; 20; 15; 20; 20; 15 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01997411) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.