PK/PD Study With G-Pump (Glucagon Infusion) in T1DM Patients
Comparison of Pharmacokinetic and Pharmacodynamic Profiles of G-Pump™ (Glucagon Infusion) vs. GlucaGen® Delivered Subcutaneously to Subjects With Type 1 Diabetes (T1DM)
2 other identifiers
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2014
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 4, 2014
CompletedFirst Posted
Study publicly available on registry
March 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedResults Posted
Study results publicly available
August 1, 2016
CompletedApril 6, 2018
March 1, 2018
5 months
March 4, 2014
May 13, 2016
March 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Time to Reach 50% of Maximum Glucose Concentration (Glucose T50%-Early)
The onset of action was assessed by determining the time in minutes required to achieve 50% of the maximum plasma concentration of glucose following each dose of glucagon.
0 to 150 minutes post-dosing
Time to Reach 50% of Maximum Glucagon Concentration (Glucagon T50%-Early)
The speed of absorption was assessed by determining the time in minutes required to achieve 50% of the maximum plasma concentration of glucagon following each dose of glucagon.
0 to 150 minutes post-dosing
Secondary Outcomes (8)
Glucagon Cmax
From 0 to 150 minutes post-dosing
Glucose Cmax
From 0 to 150 minutes post-dosing
Glucagon Tmax
From 0 to 150 minutes post-dosing
Glucose Tmax
From 0 to 150 minutes post-dosing
Glucagon AUC
From 0 to 150 minutes post-dosing
- +3 more secondary outcomes
Study Arms (2)
G-Pump™ (glucagon infusion)
EXPERIMENTALG-Pump™ (glucagon infusion); single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg
Novo Nordisk GlucaGen®
ACTIVE COMPARATORNovo Nordisk GlucaGen®; single subcutaneous infusion doses 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oregon Health & Science University
Portland, Oregon, 97239, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Martin J. Cummins, VP for Drug Development
- Organization
- Xeris Pharmaceuticals, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Jessica Castle, MD
Oregon Health and Science University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2014
First Posted
March 7, 2014
Study Start
March 1, 2014
Primary Completion
August 1, 2014
Study Completion
September 1, 2014
Last Updated
April 6, 2018
Results First Posted
August 1, 2016
Record last verified: 2018-03