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

NCT ID: NCT02081001

Last Updated: 2018-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-09-30

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.

Conditions

Hypoglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

G-Pump™ (glucagon infusion)

G-Pump™ (glucagon infusion); single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg

Group Type: EXPERIMENTAL

Novo Nordisk GlucaGen®

Intervention Type: DRUG

single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg

G-Pump™ (glucagon infusion)

Intervention Type: DRUG

single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg

Novo Nordisk GlucaGen®

Novo Nordisk GlucaGen®; single subcutaneous infusion doses 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg

Group Type: ACTIVE_COMPARATOR

Novo Nordisk GlucaGen®

Intervention Type: DRUG

single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg

G-Pump™ (glucagon infusion)

Intervention Type: DRUG

single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg

Interventions

Novo Nordisk GlucaGen®

single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg

Intervention Type: DRUG

G-Pump™ (glucagon infusion)

single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Emissary International LLC

INDUSTRY

Sponsor Role: collaborator

Xeris Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Castle, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

4R44DK096706-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

XSGO-201

Identifier Type: -

Identifier Source: org_study_id