Safety and Efficacy Study of Mini-Dose Glucagon (G-Pen Mini) in Patients With Type 1 Diabetes
Condition: Hypoglycemia
MeSH terms: Hypoglycemia
Intervention: G-Pen Mini™ (glucagon injection)
Intervention description: stable, pre-mixed, liquid glucagon for subcutaneous injection
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Hypoglycemia; Glucagon; Diabetes

Summary:

      The purpose of the study is to demonstrate that mini-doses of stable liquid glucagon (G-Pen
      Mini) produced by Xeris Pharmaceuticals are safe and effective as a treatment for mild to
      moderate hypoglycemia, a complication of diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female subjects on insulin infusion pump therapy for treatment of type 1
             diabetes

          2. Between the ages of 18 and 50 years of age, inclusive, at Screening.

          3. Females of childbearing potential with a negative serum pregnancy test prior at
             screening and negative urine pregnancy tests prior to the Treatment visits, using an
             approved forms of contraception for the duration of participation in the study (i.e.
             until after last dose).

          4. Male subjects are required to use a condom and another of the methods of contraception
             in #3 above starting at Randomization and for the duration of the study.

          5. Hemoglobin A1c (HbA1c) < 9.0 %.

          6. Evidence of a personally signed and dated informed consent document indicating that
             the subject has been informed of all pertinent aspects of the study.

          7. Subjects must be willing and able to comply with scheduled visits, treatment,
             laboratory tests and study procedures.

        Exclusion Criteria:

          1. Clinical evidence of microvascular complication(s) other than mild microalbuminuria or
             history of mild non-proliferative retinopathy

          2. Any chronic diseases or illness that interferes with glucose metabolism, except for
             T1DM, or medications other than hypothyroidism on appropriate thyroid hormone
             replacement.

          3. Blood pressure (BP) readings at Screening where Systemic BP <90 or >140 mm Hg, and
             Diastolic BP <50 or >90 mm Hg.

          4. Cardiovascular event within 6 months prior to screening such as unstable angina, acute
             coronary syndrome, myocardial infarction, therapeutic coronary procedure (e.g., stent
             placement, Percutaneous Transluminal Coronary Angioplasty (PTCA), Coronary Artery
             By-pass Grafting (CABG)), stroke or transient ischemic attack.

          5. Study participants who are pregnant at Screening.

          6. Breast feeding must be discontinued if a subject wishes to participate in this study.

          7. Positive test for hepatitis B, hepatitis C, or HIV found at Screening.

          8. Positive urine drug test for illicit drugs at Screening.

          9. History of allergies to glucagon, glucagon-like products or to any of the excipients
             in the investigational formulation.

         10. Known presence of hereditary problems of glycogen storage disease, galactose and /or
             lactose intolerance

         11. Administration of glucagon more than once within the three (3) months prior to
             Screening

         12. Subjects with any of the following abnormalities in clinical laboratory tests at
             Screening, confirmed by a single repeat, if necessary:

               -  Hemoglobin (Hb) below the lower limits of normal for the laboratory

               -  Total bilirubin above the upper limits of normal for the laboratory

               -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) above the
                  upper limits of normal for the laboratory

               -  Creatinine above the upper limits of normal for the laboratory

         13. History of regular alcohol consumption as defined by alcohol intake in a quantity
             exceeding 7 drinks per week for females or 14 drinks per week for males, where 1 drink
             = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of
             hard liquor.

         14. Participation in other studies involving administration of an investigational drug or
             device within 30 days or 5 half-lives, whichever is longer, before screening for the
             current study and during participation in the current study

         15. Whole blood donation of 1 pint (500 mL) within 8 weeks prior to Screening. Donations
             of plasma, packed red blood cells, platelets or quantities less than 500 mL are
             allowed at investigator discretion.

         16. Other severe acute or chronic medical or psychiatric condition or laboratory
             abnormality that may increase the risk associated with study participation or
             investigational product administration or may interfere with the interpretation of
             study results and, in the judgment of the investigator, would make the subject
             inappropriate for entry into this study.