Phase 3
Completed N=77
Efficacy and Safety of Nasal Glucagon for Treatment of Hypoglycemia in Adults
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT01994746 ↗
Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcomePrimary: Increase in Plasma Glucose Level to >=70mg/dL or an Increase of >=20mg/dL From Glucose Nadir — 98.7; 100 percentage of participants
◆ Published Evidence
Emerging
2citations · ~1 / year
Nasal Glucagon Reverses Insulin-induced Hypoglycemia With Less Rebound Hyperglycemia: Pooled Analysis of Clinical Trials.
Summary
The purpose of this study is to assess the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), and safety of 3 milligrams (mg) glucagon (glucagon nasal powder) administered nasally compared with commercially available glucagon given by intramuscular injection.
Linked Publications
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Nasal Glucagon Reverses Insulin-induced Hypoglycemia With Less Rebound Hyperglycemia: Pooled Analysis of Clinical Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Increase in Plasma Glucose Level to >=70mg/dL or an Increase of >=20mg/dL From Glucose Nadir |
98.7; 100 | — |
| SECONDARY Nasal and Non-nasal Effects/Symptoms |
0.00; 0.00; 2.00; 0.00; 1.00; 0.00 | — |
| SECONDARY Recovery From Symptoms of Hypoglycemia |
8.0; 7.8; 8.8; 5.3; 4.9; 3.5 | — |
| SECONDARY Time From Glucagon Administration to Blood Glucose >/=70 mg/dL or an Increase ≥20 mg/dL in Blood Glucose From Nadir |
16.2; 12.2 | — |
| SECONDARY Area Under the Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of Baseline-Adjusted Glucagon |
1882.48; 2521.87 | — |
| SECONDARY Maximum Change From Baseline Concentration (Cmax) of Glucagon |
3025.37; 3553.43 | — |
| SECONDARY Time to Maximum Change From Baseline Concentration (Tmax) of Glucagon |
0.33; 0.25 | — |
| SECONDARY Area Under the Effect Concentration Time Curve (AUEC0-1.5) of Baseline-Adjusted Glucose From Time Zero up to 90 Minutes |
106.39; 124.47 | — |
| SECONDARY Maximum Change From Baseline Concentration (Cmax) of Glucose |
114.80; 130.72 | — |
| SECONDARY Time to Maximum Change From Baseline Concentration (Tmax) of Glucose |
1.5; 1.5 | — |
Eligibility Criteria
Inclusion Criteria
To be eligible, the following inclusion criteria must be met:
- Clinical diagnosis of either type 1 diabetes receiving daily insulin since the time of diagnosis for at least 2 years or type 2 diabetes receiving multiple daily insulin doses for at least 2 years
- At least 18.0 years of age and less than 65.0 years
- Body mass index (BMI) greater than or equal to 20.0 and below or equal to 35.0 kilograms per meter squared (kg/m²)
- Weighs at least 50 kg (110 pounds)
- Females must meet one of the following criteria:
- Of childbearing potential but agree to use an accepted contraceptive regimen as described in the study procedure manual throughout the entire duration of the study (from the screening until study completion)
- Of non-childbearing potential, defined as a female who has had a hysterectomy or tubal ligation, is clinically considered infertile or is in a menopausal state (at least 1 year without menses)
- 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
- Willingness to adhere to the study requirements
Exclusion Criteria
An individual is not eligible if any of the following exclusion criteria are present:
- Females who are pregnant according to a positive urine pregnancy test, actively attempting to get pregnant, or are 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 interfere 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
- Regularly consumes 3 or more alcoholic beverages per day
- Use of an Investigational Product in another clinical trial within the past 30 days
- Donated 225 milliliters (mL) or more of blood in the previous 8 weeks before the first glucagon dosing
Data sourced from ClinicalTrials.gov (NCT01994746) 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.