PK/PD Study With G-Pump (Glucagon Infusion) in T1DM Patients
Condition: Hypoglycemia
MeSH terms: Hypoglycemia
Intervention: Novo Nordisk GlucaGen®; G-Pump™ (glucagon infusion)
Intervention description: single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg; single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg
Intervention MeSH terms: Glucagon
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Hypoglycemia; Glucagon; Artificial Pancreas

Summary:

      The purpose of the study is to assess the safety, speed of absorption, and onset of action of
      G-Pump™ (glucagon infusion) at three subcutaneous doses as compared to Novo GlucaGen®, all
      delivered via an OmniPod® infusion pump to patients with type 1 diabetes.
    

Eligibility criteria:

        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