Evaluate the Immunogenicity of a Novel Glucagon Formulation
Condition: Drug-specific Antibodies; Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Intervention: Nasal Glucagon (NG); Glucagon IM
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus; Hypoglycemia; Glucagon; Anti-glucagon Antibody; Immunogenicity

Summary:

      This study provides information on immunogenicity of Nasal Glucagon (AMG504-1) with regards
      to the potential development of treatment-emergent anti-glucagon antibodies.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Availability for the entire study period

          2. Motivated volunteer and absence of intellectual problems likely to limit the validity
             of consent to participate in the study or the compliance with protocol requirements;
             ability to cooperate adequately; ability to understand and observe the instructions of
             the physician or designee

          3. Male or female patient with a history of Type 1 or Type 2 diabetes of at least 2 years
             duration

          4. A female volunteer must meet one of the following criteria:

               1. Participant is of childbearing potential and agrees to use one of the accepted
                  contraceptive regimens throughout the entire duration of the study (from the
                  screening visit until study completion). Additionally, if the participant is
                  using systemic contraceptives, she must use an additional form of acceptable
                  contraception. An acceptable method of contraception includes one of the
                  following:

                    -  Abstinence from heterosexual intercourse

                    -  Systemic contraceptives (birth control pills, injectable/implant /insertable
                       hormonal birth control products, transdermal patch)

                    -  Intrauterine device (with and without hormones)

                    -  Condom with spermicide

                  or

               2. 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)

          5. Volunteer aged of at least 18 years but not older than 70 years

          6. Volunteer with a BMI greater than or equal to 18.50 and below 35.00 kg/m2

          7. Light-, non- or ex-smokers. A light smoker is defined as someone smoking 10 cigarettes
             or less per day for at least 3 months before day 1 of this study. An ex- smoker is
             defined as someone who completely stopped smoking for at least 6 months before day 1
             of this study

          8. 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

          9. Willingness to adhere to the protocol requirements as evidenced by the informed
             consent form (ICF) duly read, signed and dated by the volunteer

        The informed consent form must be signed by all volunteers, prior to their participation in
        the study.

        Exclusion Criteria:

          1. Females who are pregnant, actively attempting to get pregnant, or are lactating

          2. History of significant hypersensitivity to glucagon or any related products as well as
             severe hypersensitivity reactions (such as angioedema) to any drugs

          3. Presence of significant 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. Suicidal tendency, history of or disposition to seizures, state of confusion,
             clinically relevant psychiatric diseases

          5. Known presence of rare hereditary problems of galactose and /or lactose intolerance

          6. Known presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma
             (i.e. insulin secreting pancreas tumor)

          7. Presence of clinically significant findings on nasal examination or bilateral anterior
             rhinoscopy, such as structural abnormalities, nasal polyps, marked septal deviation,
             nasal tumors

          8. Nasal surgery in the previous 28 days before Day 1 of this study

          9. Use of a systemic beta-blocker drug, indomethacin, warfarin or anticholinergic drugs
             in the previous 28 days before Day 1 of this study

         10. Use of an immunomodulator medication (including steroids, glucocorticoids, tacrolimus,
             etc.) in the 28 days before day 1 of this study

         11. Any other concomitant maintenance therapy that would influence the outcome of the
             trial or compromise the safety of the patient, at the discretion of the Investigator
             and the Sponsor, in the previous 28 days before day 1 of this study

         12. Significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day,
             intake of excessive alcohol, acute or chronic)

         13. Any clinically significant illness in the previous 28 days before day 1 of this study

         14. Any history of tuberculosis and/or prophylaxis for tuberculosis

         15. Positive urine screening of alcohol and/or drugs of abuse

         16. Females who are pregnant according to a positive pregnancy test

         17. Concurrent participation or intention of participating in another clinical trial
             during this study

         18. Volunteers who took an Investigational Product (in another clinical trial) or donated
             50 mL or more of blood in the previous 28 days before day 1 of this study

         19. 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

        No participants will be allowed to enroll in this study more than once (i.e. if the study
        is conducted with more than 1 group).