A Study of Single or Repeated Doses of Glucagon in Participants With Diabetes
Condition: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Intervention: Nasal Glucagon
Intervention description: Administered intranasally.
Intervention MeSH terms: Glucagon
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study will investigate how the body processes nasal glucagon (NG) and the effect of
      nasal glucagon on the body. The study is expected to last about 50 days for each participant.
      The study is open to adults with type 1 or type 2 diabetes and will last about 50 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female with a history of Type 1 or Type 2 insulin-using diabetes of at least 1
             year duration (basal only, basal bolus, meal-time only, or twice a day pre-mixed
             insulin)

          -  A female participant must meet one of the following criteria:

               -  Participant is of childbearing potential and agrees to use one of the accepted
                  contraceptive regimens from at least 28 days prior to the first administration of
                  the study drug, during the study and for at least 30 days after the last dose of
                  the study drug

               -  Participant is of non-childbearing potential, defined as surgically sterile (i.e.
                  has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation)
                  or in a menopausal state (at least 1 year without menses)

          -  Participant with a body mass index (BMI) greater than or equal to 18.50 kilograms per
             square meter (kg/m²) and below 35.00 kg/m²

          -  Light-, non- or ex-smokers

          -  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

        Exclusion Criteria:

          -  Females who are pregnant, actively attempting to get pregnant, or are lactating

          -  History of significant hypersensitivity to glucagon or any related products as well as
             severe hypersensitivity reactions (such as angioedema) to any drugs

          -  Presence of significant gastrointestinal, liver or kidney disease, or any other
             conditions known to interfere with the absorption, distribution, metabolism or
             excretion of drugs or known to potentiate or predispose to undesired effects

          -  Suicidal tendency, history of or disposition to seizures, state of confusion,
             clinically relevant psychiatric diseases

          -  Known presence of rare hereditary problems of galactose and /or lactose intolerance,
             Lapp lactase deficiency or glucose-galactose malabsorption

          -  Presence of clinically significant findings on nasal examination or bilateral anterior
             rhinoscopy, such as structural abnormalities, nasal polyps, marked septal deviation,
             nasal tumors

          -  Nasal surgery in the previous 28 days before Day 1 of this study

          -  Daily use of a systemic beta-blocker drug, indomethacin, warfarin or anticholinergic
             drugs in the previous 28 days before Day 1 of this study

          -  Any other concomitant maintenance therapy that would influence the outcome of the
             trial or compromise the safety of the participant, at the discretion of the
             Investigator and the Sponsor, in the previous 28 days before Day 1 of this study

          -  Significant history of drug dependency or alcohol abuse

          -  Any clinically significant illness in the previous 28 days before Day 1 of this study

          -  Any history of tuberculosis and/or prophylaxis for tuberculosis

          -  Positive urine screening of alcohol and/or drugs of abuse

          -  Positive results to human immunodeficiency virus (HIV) Antigen/Antibody (Ag/Ab) Combo,
             Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or anti-Hepatitis C Virus (HCV
             (C)) tests

          -  Concurrent participation or intention of participating in another clinical trial
             during this study

          -  Participants who took an Investigational Product (in another clinical trial) in the
             previous 28 days before Day 1 of this study or who have already participated in this
             clinical study

          -  Participants who donated 50 milliliters (mL) or more of blood in the previous 28 days
             before Day 1 of this study

          -  Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical
             studies, etc.) in the previous 56 days before Day 1 of this study