Safety Study of Repeated Doses of Glucagon on Animal Starch in the Liver

Inclusion Criteria

• Type 1 diabetes mellitus diagnosed for at least 6 months
• Current usage of subcutaneous insulin pump treatment
• Age 18-65 years
• HbA1c of 5.5 - 7.7% at screening visit
• BMI 18-35 kg/m2
• Willingness to follow all study procedures, including attending all clinic visits
• Willingness to sign informed consent and HIPAA documents

Exclusion Criteria

• Pregnancy or Lactation: For women of childbearing potential: there is a requirement for a negative urine pregnancy test.
• Renal insufficiency (serum creatinine of 2.0 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 3.3 g/dL; or serum bilirubin of over 2.
• Hematocrit of less than or equal to 34%.
• Congestive heart failure, NYHA class II, III or IV.
• Coronary artery or cerebrovascular disease.
• Active foot ulceration.
• Active alcohol abuse, substance abuse, or severe mental illness (as judged by the principal investigator).
• Active malignancy, except basal cell or squamous cell skin cancers.
• Major surgical operation within 30 days prior to screening.
• Seizure disorder (epilepsy).
• Contraindication to an MRI scan, including having metallic splinters in the eye, a cardiac pacemaker, defibrillator, or any other ferromagnetic or electronically charged implanted device, or ferromagnetic clip(s) in the central nervous system.
• Currently 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.
• History weight loss of ≥ 5 lbs over the prior month.
• Weight ≥ 300 lbs.
• Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen.
• Any reason the principal investigator deems exclusionary.