Efficacy and Safety of Nasal Glucagon for Treatment of Hypoglycemia in Adults
Condition: Diabetes Mellitus, Type 1
MeSH terms: Hypoglycemia; Diabetes Mellitus, Type 1
Intervention: Nasal Glucagon; Intramuscular Glucagon
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

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.
    

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