Clinical trial NCT02081001: PK/PD Study With G-Pump (Glucagon Infusion) in T1DM Patients
Official title: Comparison of Pharmacokinetic and Pharmacodynamic Profiles of G-Pump™ (Glucagon Infusion) vs. GlucaGen® Delivered Subcutaneously to Subjects With Type 1 Diabetes (T1DM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypoglycemia
Keywords: Hypoglycemia
Glucagon
Artificial Pancreas
Lead sponsor: Xeris Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Emissary International LLC
First posted: 2014-03-07
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Time to Reach 50% of Maximum Glucose Concentration (Glucose T50%-Early)
timeFrame: 0 to 150 minutes post-dosing
measure: Time to Reach 50% of Maximum Glucagon Concentration (Glucagon T50%-Early)
timeFrame: 0 to 150 minutes post-dosing
Secondary outcomes:
measure: Glucagon Cmax
timeFrame: From 0 to 150 minutes post-dosing
measure: Glucose Cmax
timeFrame: From 0 to 150 minutes post-dosing
measure: Glucagon Tmax
timeFrame: From 0 to 150 minutes post-dosing
measure: Glucose Tmax
timeFrame: From 0 to 150 minutes post-dosing
measure: Glucagon AUC
timeFrame: From 0 to 150 minutes post-dosing
measure: Glucose AUC
timeFrame: From 0 to 150 minutes post-dosing
measure: Infusion Site Discomfort Score at 10 Minutes
timeFrame: At 10 minutes post-dosing
measure: Infusion Site Discomfort Score at 30 Minutes
timeFrame: At 30 minutes post-dosing
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Jessica Castle, MD
role: PRINCIPAL_INVESTIGATOR
References: