This study will evaluate the usefulness of a mini-glucagon dose for treatment of low blood sugar. They are looking for individuals 18-50 years old that have been diagnosed with type 1 diabetes for more than one year. To qualify, your diabetes must be well controlled and you must be on an insulin infusion pump.
- Male and female subjects who have documentation of or with laboratory evidence of GAD and/or ICA antibody positive type 1 diabetes (anti-insulin or anti-islet cell antibodies).
- Between the ages of 18 and 50 years of age, inclusive, at Screening.
- Well controlled/managed insulin-using patients without clinical evidence of chronic complications of diabetes or any other chronic disease except hypothyroidism.
- 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).
- Male subjects are required to use a condom and another of the methods of contraception in #4 above starting at Randomization and for the duration of the study.
- HgA1c < 9.0 %.
- All subjects must be on an insulin infusion pump
- No other medications other than thyroid replacement and insulin
- No other chronic illnesses other than well controlled hypothyroidism.
- Normal plasma concentrations of Hgb, AST and ALT.
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- Subjects must be willing and able to comply with scheduled visits, treatment, laboratory tests and study procedures.