Trial Outcomes & Findings for G-Pen™ for Hypoglycemia Rescue in T1D Patients (NCT NCT02423980)

Last Updated: 2017-07-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

0-90 minutes

Results posted on

2017-07-07

Participant Flow

A total of 7 adults with type 1 diabetes were recruited at a clinical research center over a period of 1 month.

One subject was given the 1 mg dose of glucagon at both treatment visits, so only 6 subjects received the 0.5 mg dose.

Participant milestones

Participant milestones
Measure	G-Pen™ (Glucagon Injection) 1 mg First, Followed by 0.5 mg 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.
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

G-Pen™ for Hypoglycemia Rescue in T1D Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	G-Pen™ (Glucagon Injection) 1 mg First, Followed by 0.5 mg n=7 Participants 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.
Region of Enrollment United States	7 Participants n=5 Participants
Age, Continuous	42 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0-90 minutes

Population: All treated subjects

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.

Outcome measures

Outcome measures
Measure	Glucagon 1 mg n=7 Participants 1 mg G-Pen™ (glucagon injection) Glucagon	Glucagon 0.5 mg n=6 Participants 0.5 mg G-Pen™ (glucagon injection) Glucagon
Number of Subjects With Plasma Glucose > 70 mg/dL at 30 Minutes Post-treatment	7 participants with positive response	6 participants with positive response

SECONDARY outcome

Timeframe: 0-90 minutes

Population: All treated subjects

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.

Outcome measures

Outcome measures
Measure	Glucagon 1 mg n=7 Participants 1 mg G-Pen™ (glucagon injection) Glucagon	Glucagon 0.5 mg n=6 Participants 0.5 mg G-Pen™ (glucagon injection) Glucagon
Time to Plasma Glucose > 70 mg/dL	15 minutes Interval 10.0 to 20.0	15 minutes Interval 10.0 to 20.0

SECONDARY outcome

Timeframe: 0-30 minutes

Population: Subjects with symptoms of hypoglycemia at time of treatment

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.

Outcome measures

Outcome measures
Measure	Glucagon 1 mg n=6 Participants 1 mg G-Pen™ (glucagon injection) Glucagon	Glucagon 0.5 mg n=4 Participants 0.5 mg G-Pen™ (glucagon injection) Glucagon
Time to Resolution of Induced Hypoglycemia Symptoms	20 minutes Interval 5.0 to 30.0	27.5 minutes Interval 25.0 to 30.0

Adverse Events

Glucagon 1 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Glucagon 0.5 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Glucagon 1 mg n=7 participants at risk 1 mg G-Pen™ (glucagon injection) Glucagon	Glucagon 0.5 mg n=6 participants at risk 0.5 mg G-Pen™ (glucagon injection) Glucagon
Nervous system disorders Vasovagal syncope	14.3% 1/7 • Number of events 1 • Total evaluation time was up to 3 weeks per subject. 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.	0.00% 0/6 • Total evaluation time was up to 3 weeks per subject. 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.

Other adverse events

Other adverse events
Measure	Glucagon 1 mg n=7 participants at risk 1 mg G-Pen™ (glucagon injection) Glucagon	Glucagon 0.5 mg n=6 participants at risk 0.5 mg G-Pen™ (glucagon injection) Glucagon
Gastrointestinal disorders Nausea	42.9% 3/7 • Number of events 4 • Total evaluation time was up to 3 weeks per subject. 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.	33.3% 2/6 • Number of events 2 • Total evaluation time was up to 3 weeks per subject. 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.
Gastrointestinal disorders Vomiting	42.9% 3/7 • Number of events 3 • Total evaluation time was up to 3 weeks per subject. 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.	0.00% 0/6 • Total evaluation time was up to 3 weeks per subject. 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.
General disorders Fatigue	0.00% 0/7 • Total evaluation time was up to 3 weeks per subject. 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.	16.7% 1/6 • Number of events 1 • Total evaluation time was up to 3 weeks per subject. 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.

Additional Information

Martin Cummins, VP Drug Development

Xeris Pharmaceuticals, Inc.

Phone: 512-498-2675

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place