G-Pen™ for Hypoglycemia Rescue in T1D Patients
G-Pen™ (Glucagon Injection) for Induced Hypoglycemia Rescue in Adult Patients With T1D
1 other identifier
interventional
7
1 country
1
Brief Summary
This is an open-label, exploratory pilot study in patients with T1D. The study will involve two daytime clinical research center visits 7-14 days apart. Subjects will receive a single injection of G-Pen™ (glucagon injection) at each visit.
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 Apr 2015
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
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 9, 2015
CompletedFirst Posted
Study publicly available on registry
April 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
April 24, 2017
CompletedJuly 7, 2017
June 1, 2017
1 month
April 9, 2015
February 12, 2017
June 7, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Subjects With Plasma Glucose > 70 mg/dL at 30 Minutes Post-treatment
For 90 minutes following treatment, plasma glucose was measured every 5 minutes, with an increase in plasma glucose to \>70 mg/dL within 30 minutes of treatment being considered a positive response.
0-90 minutes
Secondary Outcomes (2)
Time to Plasma Glucose > 70 mg/dL
0-90 minutes
Time to Resolution of Induced Hypoglycemia Symptoms
0-30 minutes
Study Arms (1)
Glucagon
EXPERIMENTAL1 mg G-Pen™ (glucagon injection) first, followed by 0.5 mg
Interventions
Eligibility Criteria
You may qualify if:
- Type 1 diabetes mellitus for at least 24 months
You may not qualify if:
- Pregnant or Lactating
- HbA1c \>10.5% at screening
- Use of \> 2.0 U/kg total insulin dose per day
- Inadequate bilateral venous access in both arms
- Renal insufficiency
- Congestive heart failure, NYHA class II, III or IV
- Active malignancy within 5 years from screening
- Major surgical operation within 30 days prior to screening
- Seizure or bleeding disorder
- Glycogen storage disease
- Active substance or alchohol abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Martin Cummins, VP Drug Development
- Organization
- Xeris Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2015
First Posted
April 22, 2015
Study Start
April 1, 2015
Primary Completion
May 1, 2015
Study Completion
June 1, 2015
Last Updated
July 7, 2017
Results First Posted
April 24, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share