Back to resultsG-Pen™ for Hypoglycemia Rescue in T1D Patients
Primary Purpose
Hypoglycemia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Glucagon
Sponsored by
About this trial
This is an interventional treatment trial for Hypoglycemia
Eligibility Criteria
Inclusion Criteria:
- Type 1 diabetes mellitus for at least 24 months
Exclusion Criteria:
- 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
Sites / Locations
- Diablo Clinical Research, Inc.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Glucagon
Arm Description
1 mg G-Pen™ (glucagon injection) first, followed by 0.5 mg
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Time to Plasma Glucose > 70 mg/dL
Following treatment, plasma glucose was measured every 5 minutes. The first such measurement at which plasma glucose concentration was observed to be >70 mg/dL was reported as the time to response.
Time to Resolution of Induced Hypoglycemia Symptoms
Prior to and every 5 minutes after treatment, subjects were asked to rate the severity of each of 8 symptoms on a scale from 1 to 6, with 1 indicating the symptom was absent and 6 indicating the symptom was severe. The sum of the scores for the 8 individual symptoms was reported as the total hypoglycemia symptom score, which ranged from 8-48. The first time point post-treatment at which total hypoglycemia symptom score = 8 (i.e., all symptoms were absent) was considered the time to resolution. One and two subjects were unevaluable for response to the 1 mg and 0.5 mg doses of glucagon, respectively, as they reported no symptoms (i.e., total symptom score = 8) prior to treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02423980
Brief Title
G-Pen™ for Hypoglycemia Rescue in T1D Patients
Official Title
G-Pen™ (Glucagon Injection) for Induced Hypoglycemia Rescue in Adult Patients With T1D
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xeris Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Following eligibility confirmation, each study participant will undergo two episodes of insulin-induced hypoglycemia with plasma glucose < 50 mg/dL. Both episodes will be treated with a single subcutaneous injection of G-Pen™ glucagon. For the first treatment visit, all subjects will receive a 1 mg dose of G-Pen™ glucagon. The investigator will have discretion to repeat this same dose at the second treatment visit or give a 0.5 mg dose of G-Pen™ glucagon. A follow-up phone call will be conducted 3-7 days following administration of the final dose of study drug as a safety check.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoglycemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glucagon
Arm Type
Experimental
Arm Description
1 mg G-Pen™ (glucagon injection) first, followed by 0.5 mg
Intervention Type
Drug
Intervention Name(s)
Glucagon
Other Intervention Name(s)
G-Pen™ (glucagon injection)
Primary Outcome Measure Information:
Title
Number of Subjects With Plasma Glucose > 70 mg/dL at 30 Minutes Post-treatment
Description
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.
Time Frame
0-90 minutes
Secondary Outcome Measure Information:
Title
Time to Plasma Glucose > 70 mg/dL
Description
Following treatment, plasma glucose was measured every 5 minutes. The first such measurement at which plasma glucose concentration was observed to be >70 mg/dL was reported as the time to response.
Time Frame
0-90 minutes
Title
Time to Resolution of Induced Hypoglycemia Symptoms
Description
Prior to and every 5 minutes after treatment, subjects were asked to rate the severity of each of 8 symptoms on a scale from 1 to 6, with 1 indicating the symptom was absent and 6 indicating the symptom was severe. The sum of the scores for the 8 individual symptoms was reported as the total hypoglycemia symptom score, which ranged from 8-48. The first time point post-treatment at which total hypoglycemia symptom score = 8 (i.e., all symptoms were absent) was considered the time to resolution. One and two subjects were unevaluable for response to the 1 mg and 0.5 mg doses of glucagon, respectively, as they reported no symptoms (i.e., total symptom score = 8) prior to treatment.
Time Frame
0-30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 1 diabetes mellitus for at least 24 months
Exclusion Criteria:
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
Facility Information:
Facility Name
Diablo Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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G-Pen™ for Hypoglycemia Rescue in T1D Patients
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