Trial Outcomes & Findings for G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes (NCT NCT03738865)

NCT ID: NCT03738865

Last Updated: 2020-05-22

Results Overview

Number of subjects with an increase in plasma glucose concentration from below 54 mg/dL (3 mmol/L) to greater than 70 mg/dL (3.89 mmol/L) or an increase in plasma glucose concentration \> 20 mg/dL (\> 1.11 mmol/L) within 30 minutes after administration of glucagon

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 132 participants
• Primary outcome timeframe: At 30 minutes following administration of study drug
• Results posted on: 2020-05-22

Participant Flow

132 subjects were randomized, however 1 subject withdrew prior to dosing, therefore 131 subjects received study drug.

Participant milestones

Measure	G-Pen, Then Novo Glucagon Participants first received G-Pen 1 mg subcutaneous injection each. After a washout period of 7-28 days, they then received Novo Glucagon 1 mg subcutaneous injection	Novo Glucagon, Then G-Pen Participants first received Novo Glucagon 1 mg subcutaneous injection each. After a washout period of 7-28 days, they then received G-Pen 1 mg subcutaneous injection
Overall Study STARTED	66	66
Overall Study COMPLETED	61	62
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Measure	G-Pen, Then Novo Glucagon Participants first received G-Pen 1 mg subcutaneous injection each. After a washout period of 7-28 days, they then received Novo Glucagon 1 mg subcutaneous injection	Novo Glucagon, Then G-Pen Participants first received Novo Glucagon 1 mg subcutaneous injection each. After a washout period of 7-28 days, they then received G-Pen 1 mg subcutaneous injection
Overall Study Withdrawal by Subject	3	3
Overall Study Adverse Event	2	0
Overall Study Physician Decision	0	1

Baseline Characteristics

G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes

Baseline characteristics by cohort

Measure	G-Pen, Then Novo Glucagon n=66 Participants Participants first received G-Pen 1 mg subcutaneous injection each. After a washout period of 7-28 days, they then received Novo Glucagon 1 mg subcutaneous injection.	Novo Glucagon, Then G-Pen n=66 Participants Participants first received Novo Glucagon 1 mg subcutaneous injection each. After a washout period of 7-28 days, they then received G-Pen 1 mg subcutaneous injection.	Total n=132 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	63 Participants n=5 Participants	63 Participants n=7 Participants	126 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	33 Participants n=7 Participants	62 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	33 Participants n=7 Participants	70 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	65 Participants n=5 Participants	63 Participants n=7 Participants	128 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	62 Participants n=5 Participants	61 Participants n=7 Participants	123 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 30 minutes following administration of study drug

Population: Intent-to-Treat Population

Number of subjects with an increase in plasma glucose concentration from below 54 mg/dL (3 mmol/L) to greater than 70 mg/dL (3.89 mmol/L) or an increase in plasma glucose concentration > 20 mg/dL (> 1.11 mmol/L) within 30 minutes after administration of glucagon

Outcome measures

Measure	G-Pen n=128 Participants Participants received G-Pen 1 mg subcutaneous injection each.	Novo Glucagon n=123 Participants Participants received Novo Glucagon 1 mg subcutaneous injection each.
Severe Hypoglycemia Rescue	127 Participants	123 Participants

SECONDARY outcome

Timeframe: At 30 minutes following a decision to administer study drug

Population: Intent-to-Treat Population

Number of subjects with an increase in plasma glucose concentration from below 54 mg/dL (3 mmol/L) to greater than 70 mg/dL (3.89 mmol/L) within 30 minutes of a decision to dose

Outcome measures

Measure	G-Pen n=128 Participants Participants received G-Pen 1 mg subcutaneous injection each.	Novo Glucagon n=123 Participants Participants received Novo Glucagon 1 mg subcutaneous injection each.
Plasma Glucose Response 1	127 Participants	123 Participants

SECONDARY outcome

Timeframe: At 0-30 minutes following a decision to administer study drug

Population: Intent-to-Treat Population

Number of subjects with an increase in plasma glucose concentration > 20 mg/dL (> 1.11 mmol/L) after administration of glucagon.

Outcome measures

Measure	G-Pen n=128 Participants Participants received G-Pen 1 mg subcutaneous injection each.	Novo Glucagon n=123 Participants Participants received Novo Glucagon 1 mg subcutaneous injection each.
Plasma Glucose Response 2	127 Participants	123 Participants

SECONDARY outcome

Timeframe: At 0-10 minutes from a decision to administer study drug

Population: Intent-to-Treat Population

Mean time (minutes) to administer study drug from a decision to dose

Outcome measures

Measure	G-Pen n=128 Participants Participants received G-Pen 1 mg subcutaneous injection each.	Novo Glucagon n=123 Participants Participants received Novo Glucagon 1 mg subcutaneous injection each.
Administration Time	0.79 minutes Standard Deviation 0.530	1.76 minutes Standard Deviation 0.678

SECONDARY outcome

Timeframe: At 0-90 minutes following administration of study drug

Population: Intent-to-Treat Population

Mean time (minutes) to complete resolution of the overall sensation of hypoglycemia from a decision to dose

Outcome measures

Measure	G-Pen n=128 Participants Participants received G-Pen 1 mg subcutaneous injection each.	Novo Glucagon n=123 Participants Participants received Novo Glucagon 1 mg subcutaneous injection each.
Hypoglycemia Resolution	15.69 minutes Standard Deviation 7.428	15.32 minutes Standard Deviation 8.479

Adverse Events

G-Pen

Serious events: 0 serious events

Other events: 67 other events

Deaths: 0 deaths

Novo Glucagon

Serious events: 0 serious events

Other events: 57 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	G-Pen n=127 participants at risk G-Pen: 1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector	Novo Glucagon n=123 participants at risk Novo Glucagon: 1 mg subcutaneous injection of Novo Glucagon (glucagon injection)
Gastrointestinal disorders Nausea	42.5% 54/127 • Adverse events were collected for up to 5 weeks, from the time of consent through the follow-up visit. Treatment-Emergent Adverse Events (TEAE) Note: Some subjects experienced multiple adverse events. Consequently, the sum of the number of subjects experiencing each individual adverse events is greater than the number of unique subjects experiencing at least one adverse event	44.7% 55/123 • Adverse events were collected for up to 5 weeks, from the time of consent through the follow-up visit. Treatment-Emergent Adverse Events (TEAE) Note: Some subjects experienced multiple adverse events. Consequently, the sum of the number of subjects experiencing each individual adverse events is greater than the number of unique subjects experiencing at least one adverse event
Gastrointestinal disorders Vomiting	12.6% 16/127 • Adverse events were collected for up to 5 weeks, from the time of consent through the follow-up visit. Treatment-Emergent Adverse Events (TEAE) Note: Some subjects experienced multiple adverse events. Consequently, the sum of the number of subjects experiencing each individual adverse events is greater than the number of unique subjects experiencing at least one adverse event	13.8% 17/123 • Adverse events were collected for up to 5 weeks, from the time of consent through the follow-up visit. Treatment-Emergent Adverse Events (TEAE) Note: Some subjects experienced multiple adverse events. Consequently, the sum of the number of subjects experiencing each individual adverse events is greater than the number of unique subjects experiencing at least one adverse event
Nervous system disorders Headache	5.5% 7/127 • Adverse events were collected for up to 5 weeks, from the time of consent through the follow-up visit. Treatment-Emergent Adverse Events (TEAE) Note: Some subjects experienced multiple adverse events. Consequently, the sum of the number of subjects experiencing each individual adverse events is greater than the number of unique subjects experiencing at least one adverse event	7.3% 9/123 • Adverse events were collected for up to 5 weeks, from the time of consent through the follow-up visit. Treatment-Emergent Adverse Events (TEAE) Note: Some subjects experienced multiple adverse events. Consequently, the sum of the number of subjects experiencing each individual adverse events is greater than the number of unique subjects experiencing at least one adverse event

Additional Information

Chelsea Boundy

Xeris Pharmaceuticals, Inc.

Phone: 312-517-1466

Email: cboundy@xerispharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee Neither the Institution nor the principal investigator may submit for publication or presentation, the results of this trial without prior written consent of the sponsor.
• Publication restrictions are in place

Restriction type: OTHER