Safety and Efficacy Study of Mini-Dose Glucagon (G-Pen Mini) in Patients With Type 1 Diabetes

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.