G-Pen™ for Hypoglycemia Rescue in T1D Patients

• Sponsor: Xeris Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02423980
• Collaborator: (none)
• Enrollment: 7
• Location: 1
• Arm: 1
• Duration (Months): 2
• Patients Per Site Per Month: 3.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypoglycemia	Drug: Glucagon	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: G-Pen™ (Glucagon Injection) for Induced Hypoglycemia Rescue in Adult Patients With T1D
• Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: May 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Glucagon 1 mg G-Pen™ (glucagon injection) first, followed by 0.5 mg	Drug: Glucagon; Other Names: G-Pen™ (glucagon injection)

Outcome Measures

Primary Outcome Measures

1. Number of Subjects With Plasma Glucose > 70 mg/dL at 30 Minutes Post-treatment [0-90 minutes]

   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

1. Time to Plasma Glucose > 70 mg/dL [0-90 minutes]

   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.

2. Time to Resolution of Induced Hypoglycemia Symptoms [0-30 minutes]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Diablo Clinical Research, Inc.	Walnut Creek	California	United States	94598

Sponsors and Collaborators

• Xeris Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xeris Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02423980
• Other Study ID Numbers: XSGP-202
• First Posted: Apr 22, 2015
• Last Update Posted: Jul 7, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Hypoglycemia; Glucagon; Glucagon-Like Peptide 1

Study Results

Participant Flow

Recruitment Details	A total of 7 adults with type 1 diabetes were recruited at a clinical research center over a period of 1 month.
Pre-assignment Detail	One subject was given the 1 mg dose of glucagon at both treatment visits, so only 6 subjects received the 0.5 mg dose.

Arm/Group Title	G-Pen™ (Glucagon Injection) 1 mg First, Followed by 0.5 mg
Arm/Group Description	A 1 mg dose of glucagon at an initial clinic visit, followed by a 0.5 mg dose of glucagon given at a subsequent clinic visit after a 1-2 week wash-out.
Period Title: Overall Study
STARTED	7
COMPLETED	7
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	G-Pen™ (Glucagon Injection) 1 mg First, Followed by 0.5 mg
Arm/Group Description	A 1 mg dose of G-Pen was given at an initial clinic visit. After a 1-2 week wash-out, subjects received a 0.5 mg dose of G-Pen™ at a second visit.
Overall Participants	7
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	42
Sex: Female, Male (Count of Participants)
Female	6 85.7%
Male	1 14.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 14.3%
Not Hispanic or Latino	6 85.7%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 14.3%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	6 85.7%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	7 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All treated subjects

Arm/Group Title	Glucagon 1 mg	Glucagon 0.5 mg
Arm/Group Description	1 mg G-Pen™ (glucagon injection) Glucagon	0.5 mg G-Pen™ (glucagon injection) Glucagon
Measure Participants	7	6
Number [participants with positive response]	7 100%	6 NaN

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All treated subjects

Arm/Group Title	Glucagon 1 mg	Glucagon 0.5 mg
Arm/Group Description	1 mg G-Pen™ (glucagon injection) Glucagon	0.5 mg G-Pen™ (glucagon injection) Glucagon
Measure Participants	7	6
Median (Full Range) [minutes]	15	15

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Subjects with symptoms of hypoglycemia at time of treatment

Arm/Group Title	Glucagon 1 mg	Glucagon 0.5 mg
Arm/Group Description	1 mg G-Pen™ (glucagon injection) Glucagon	0.5 mg G-Pen™ (glucagon injection) Glucagon
Measure Participants	6	4
Median (Full Range) [minutes]	20	27.5

Adverse Events

Time Frame	Total evaluation time was up to 3 weeks per subject.
Adverse Event Reporting Description	Treatment-emergent events observed during the dosing visits or subsequently reported by the subjects between visits or at the follow-up phone call occurring 3-7 days after the second treatment visit were recorded.
Arm/Group Title	Glucagon 1 mg		Glucagon 0.5 mg
Arm/Group Description	1 mg G-Pen™ (glucagon injection) Glucagon		0.5 mg G-Pen™ (glucagon injection) Glucagon
All Cause Mortality
	Glucagon 1 mg		Glucagon 0.5 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Glucagon 1 mg		Glucagon 0.5 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/7 (14.3%)		0/6 (0%)
Nervous system disorders
Vasovagal syncope	1/7 (14.3%)	1	0/6 (0%)	0
Other (Not Including Serious) Adverse Events
	Glucagon 1 mg		Glucagon 0.5 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/7 (42.9%)		2/6 (33.3%)
Gastrointestinal disorders
Nausea	3/7 (42.9%)	4	2/6 (33.3%)	2
Vomiting	3/7 (42.9%)	3	0/6 (0%)	0
General disorders
Fatigue	0/7 (0%)	0	1/6 (16.7%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.