Trial Outcomes & Findings for Efficacy and Safety of Nasal Glucagon for Treatment of Hypoglycemia in Adults (NCT NCT01994746)

NCT ID: NCT01994746

Last Updated: 2019-09-23

Results Overview

Increase in blood glucose to ≥70 mg/dL or an increase of ≥20 mg/dL from glucose nadir within 30 minutes after receiving study glucagon, without receiving additional actions to increase the blood glucose level defines treatment success. Due to the residual activity of circulating insulin, glucose nadir was defined as the minimum glucose measurement at the time of, or within 10 minutes following glucagon administration.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

77 participants

Primary outcome timeframe

Within 30 minutes after receiving glucagon at both dosing visits (glucose was measured at pre-dose; 5, 10, 15, 20, 25, and 30 minutes following glucagon administration)

Results posted on

2019-09-23

Participant Flow

77 Type 1 (T1D) and 6 Type 2 diabetes (T2D) participants were recruited. Results reported include T1D participants only since this was the pre-specified primary population.

Participant milestones

Participant milestones
Measure	NG 1st/IM Glucagon 2nd At the first visit, 3 milligrams (mg) of nasal glucagon (NG). At the second visit, 1 mg of intramuscular (IM) glucagon.	IM Glucagon 1st/NG 2nd At the first visit, 1 mg of IM glucagon. At the second visit, 3 mg of NG glucagon.
First Visit STARTED	39	38
First Visit Received At Least 1 Dose	39	38
First Visit COMPLETED	39	38
First Visit NOT COMPLETED	0	0
Second Visit STARTED	38	38
Second Visit Completed Both Dosing Visits	38	38
Second Visit COMPLETED	38	38
Second Visit NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of Nasal Glucagon for Treatment of Hypoglycemia in Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=77 Participants At one visit, a nasal glucagon (NG) dose of 3 mg. At another visit, 1 mg intramuscular (IM) glucagon The order of the visits were randomized.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	77 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	33 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	75 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	1 Participants n=5 Participants
Race (NIH/OMB) White	74 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	77 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 30 minutes after receiving glucagon at both dosing visits (glucose was measured at pre-dose; 5, 10, 15, 20, 25, and 30 minutes following glucagon administration)

Population: All enrolled participants who completed both eligible Study/Dosing Visits.

Outcome measures

Outcome measures
Measure	Nasal Glucagon (NG) n=75 Participants At one visit, 3 mg of NG.	Intramuscular (IM) Glucagon n=75 Participants At a separate visit, 1 mg of IM glucagon.
Increase in Plasma Glucose Level to >=70mg/dL or an Increase of >=20mg/dL From Glucose Nadir	98.7 percentage of participants	100 percentage of participants

SECONDARY outcome

Timeframe: Pre-dose; 15, 30, 60, and 90 post glucagon administration

Population: All enrolled T1D participants that completed the required dosing visits. Study dosing visits occur on Day 0 and then again after the washout period between Day 7 to Day 28.

Symptoms of runny nose, nasal congestion and/or itching, sneezing, watery and/or itchy eyes, redness of eyes, and itching of ears and/or throat were assessed. This was done via the "Nasal Non-nasal Score Questionnaire". Each of the 9 symptoms is assigned an integer value from 0 to 3; higher values indicate more severe symptoms (a score of 0 indicates no symptoms). The reported results indicate the cohort median out of a possible maximum value of 27 (summing all 9 questions for each subject and reporting the median/IQR across participants).

Outcome measures

Outcome measures
Measure	Nasal Glucagon (NG) n=77 Participants At one visit, 3 mg of NG.	Intramuscular (IM) Glucagon n=76 Participants At a separate visit, 1 mg of IM glucagon.
Nasal and Non-nasal Effects/Symptoms Pre-dose	0.00 units on a scale Interval 0.0 to 1.0	0.00 units on a scale Interval 0.0 to 1.0
Nasal and Non-nasal Effects/Symptoms 15 minutes post glucagon administration	2.00 units on a scale Interval 1.0 to 5.0	0.00 units on a scale Interval 0.0 to 0.0
Nasal and Non-nasal Effects/Symptoms 30 minutes post glucagon administration	1.00 units on a scale Interval 0.0 to 3.0	0.00 units on a scale Interval 0.0 to 0.5
Nasal and Non-nasal Effects/Symptoms 60 minutes post glucagon administration	1.00 units on a scale Interval 0.0 to 3.0	0.00 units on a scale Interval 0.0 to 0.0
Nasal and Non-nasal Effects/Symptoms 90 minutes post glucagon administration	1.00 units on a scale Interval 0.0 to 2.5	0.00 units on a scale Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Pre-dose;15, 30, 45 and 60 minutes following administration of glucagon

Population: All enrolled participants who completed at least one post administration survey.

Recovery from hypoglycemia symptoms were assessed using the Edinburgh Hypoglycemia Scale. The Edinburgh Hypoglycemia Symptom Scale measures the intensity of 15 commonly experienced hypoglycemic symptoms on a 7-point Likert scale (1 = not present, 7 = very intense). The higher the score, the more intense the hypoglycemia symptoms. The sum of each symptom score would yield a range of 15 to 105 (i.e., 15 x 7 =105). The total score was calculated as the sum of each symptom score minus 15, and summarized at each time point by treatment group.

Outcome measures

Outcome measures
Measure	Nasal Glucagon (NG) n=77 Participants At one visit, 3 mg of NG.	Intramuscular (IM) Glucagon n=76 Participants At a separate visit, 1 mg of IM glucagon.
Recovery From Symptoms of Hypoglycemia Pre-dose	8.0 units on a scale Standard Deviation 7.7	7.8 units on a scale Standard Deviation 7.1
Recovery From Symptoms of Hypoglycemia 15 minutes post glucagon administration	8.8 units on a scale Standard Deviation 8.3	5.3 units on a scale Standard Deviation 5.2
Recovery From Symptoms of Hypoglycemia 30 minutes post glucagon administration	4.9 units on a scale Standard Deviation 4.7	3.5 units on a scale Standard Deviation 3.9
Recovery From Symptoms of Hypoglycemia 45 minutes post glucagon administration	3.8 units on a scale Standard Deviation 3.1	3.0 units on a scale Standard Deviation 3.0
Recovery From Symptoms of Hypoglycemia 60 minutes post glucagon administration	3.9 units on a scale Standard Deviation 3.1	3.1 units on a scale Standard Deviation 2.9

SECONDARY outcome

Timeframe: Pre-dose; 5, 10, 15, 20, 25, and 30 minutes following glucagon administration

Population: All enrolled participants that completed the required dosing visits with eligible glucose and glucagon levels. Study dosing visits occur on Day 0 and then again after the washout period between Day 7 to Day 28.

The mean time from glucagon administration to blood glucose \>/=70 mg/dL or an increase ≥20 mg/dL in blood glucose from nadir.