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

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xeris Pharmaceuticals
• Collaborators: Emissary International LLC; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Glucagon; Glucagon-Like Peptide 1

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