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

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