PK/PD Study With G-Pump (Glucagon Infusion) in T1DM Patients

Inclusion Criteria:

- Males or females diagnosed with type 1 diabetes mellitus for at least 24 months

- Current usage of subcutaneous insulin pump treatment

- Age 18-65 years

- C-peptide level < 0.5 ng/ml

- Willingness to follow all study procedures, including attending all clinic visits

- Subject has provided informed consent and has signed and dated an informed consent
form before any trial-related activities

Exclusion Criteria:

- Pregnant and/ or Lactating: For women of childbearing potential: there is a
requirement for a negative urine pregnancy test and for agreement to use contraception
during the study and for at least 1 month after participating in the study.

- HbA1c >10.0%

- Renal insufficiency (serum creatinine of 1.2 mg/dL or greater)

- Serum ALT or AST equal to or greater than 3 times the upper limit of normal; hepatic
synthetic insufficiency as defined as a serum albumin of less than 3.0 g/dL; or serum
bilirubin of over 2.0.

- Hematocrit of less than or equal to 34%

- Congestive heart failure, NYHA class II, III or IV

- History of coronary artery disease

- Active foot ulceration

- History of a cerebrovascular accident

- Active alcohol abuse or substance abuse

- Active malignancy, except basal cell or squamous cell skin cancers

- Major surgical operation within 30 days prior to screening

- Seizure disorder

- Current administration of oral or parenteral corticosteroids

- Use of an investigational drug within 30 days prior to screening

- Bleeding disorder, treatment with warfarin, or platelet count below 50,000

- Proliferative or severe non-proliferative retinopathy

- Gastroparesis

- Personal or family history of pheochromocytoma or disorder with increased risk of
pheochromocytoma (MEN 2, neurofibromatosis, or Von Hippel-Lindau disease)

- Insulinoma

- Allergies to glucagon or glucagon-like products, or any history of significant
hypersensitivity to glucagon or any related products.

- Glycogen storage disease

- Any concurrent illness, other than diabetes, that is not controlled by a stable
therapeutic regimen

- Whole blood donation of 1 pint (500 mL) within 8 weeks prior to Screening.

- Any reason the principal investigator deems exclusionary