Trial Outcomes & Findings for Safety and Efficacy Study of Mini-Dose Glucagon (G-Pen Mini) in Patients With Type 1 Diabetes (NCT NCT02081014)
NCT ID: NCT02081014
Last Updated: 2018-04-05
Results Overview
Number of serious adverse events (SAEs) per treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
From first dose until follow-up call, up to 7 weeks per subject
Results posted on
2018-04-05
Participant Flow
A total of 13 adults \< 50 years of age with type 1 diabetes were recruited over a period of 5 months to receive treatment at a university-affiliated state hospital-based endocrinology clinic.
A total of 13 subjects were randomized to treatment. Due to poor venous access an IV could not be started in one subject, so only 12 subjects received treatment.
Participant milestones
| Measure |
G-Pen Mini™ Dose Order: 75, 150 & 300 Micrograms
G-Pen Mini™ (glucagon injection): two 75 microgram (ug) subcutaneous (SC) injections at treatment visit 1, followed by a 2-21 day washout, then two 150 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 300 ug SC injections at treatment visit 3.
|
G-Pen Mini™ Dose Order: 75, 300 & 150 Micrograms
G-Pen Mini™ (glucagon injection): two 75 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 300 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 150 ug SC injections at treatment visit 3.
|
G-Pen Mini™ Dose Order: 150, 75 & 300 Micrograms
G-Pen Mini™ (glucagon injection): two 150 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 75 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 300 ug SC injections at treatment visit 3.
|
G-Pen Mini™ Dose Order: 150, 300 & 75 Micrograms
G-Pen Mini™ (glucagon injection): two 150 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 300 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 150 ug SC injections at treatment visit 3.
|
G-Pen Mini™ Dose Order: 300, 75 & 150 Micrograms
G-Pen Mini™ (glucagon injection): two 300 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 75 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 150 ug SC injections at treatment visit 3.
|
G-Pen Mini™ Dose Order: 300, 150 & 75 Micrograms
G-Pen Mini™ (glucagon injection): two 300 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 150 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 75 ug SC injections at treatment visit 3.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study of Mini-Dose Glucagon (G-Pen Mini) in Patients With Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Total Study Group
n=12 Participants
Includes all 12 treated subjects
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
26.4 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 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
|
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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 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
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
|
HbA1c
|
7.7 percent
STANDARD_DEVIATION 0.48 • n=5 Participants
|
|
Body Weight
|
73.6 kg
STANDARD_DEVIATION 12.08 • n=5 Participants
|
|
Duration of Diabetes
|
11.6 years
STANDARD_DEVIATION 6.02 • n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose until follow-up call, up to 7 weeks per subjectPopulation: All randomized subjects who received at least one dose of study drug
Number of serious adverse events (SAEs) per treatment
Outcome measures
| Measure |
G-Pen Mini™ (Glucagon Injection) 75 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart
|
G-Pen Mini™ (Glucagon Injection) 150 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart
|
G-Pen Mini™ (Glucagon Injection) 300 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart
|
|---|---|---|---|
|
Serious Adverse Events
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injectionPopulation: All randomized subjects who received at least one dose of study drug
Pharmacokinetic parameter: Maximum concentration of glucagon
Outcome measures
| Measure |
G-Pen Mini™ (Glucagon Injection) 75 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart
|
G-Pen Mini™ (Glucagon Injection) 150 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart
|
G-Pen Mini™ (Glucagon Injection) 300 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart
|
|---|---|---|---|
|
Glucagon Cmax (Fasting)
|
233.8 pg/ml
Standard Error 34
|
380.7 pg/ml
Standard Error 34
|
663.6 pg/ml
Standard Error 34
|
SECONDARY outcome
Timeframe: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injectionPopulation: All randomized subject who received at least one dose of study drug
Pharmacokinetic parameter: Maximum concentration of glucagon
Outcome measures
| Measure |
G-Pen Mini™ (Glucagon Injection) 75 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart
|
G-Pen Mini™ (Glucagon Injection) 150 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart
|
G-Pen Mini™ (Glucagon Injection) 300 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart
|
|---|---|---|---|
|
Glucagon Cmax (Post-insulin)
|
253.4 pg/ml
Standard Error 30.1
|
335.4 pg/ml
Standard Error 30.1
|
561.7 pg/ml
Standard Error 29.9
|
SECONDARY outcome
Timeframe: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injectionPopulation: All randomized subjects who received at least one dose of study drug
Pharmacokinetic parameter: Area under the glucagon concentration curve from 0 to 120 minutes
Outcome measures
| Measure |
G-Pen Mini™ (Glucagon Injection) 75 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart
|
G-Pen Mini™ (Glucagon Injection) 150 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart
|
G-Pen Mini™ (Glucagon Injection) 300 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart
|
|---|---|---|---|
|
Glucagon Area Under the Curve (AUC) (Fasting)
|
265.4 (pg/ml)*hour
Standard Error 35.4
|
389.6 (pg/ml)*hour
Standard Error 35.4
|
735.3 (pg/ml)*hour
Standard Error 35.4
|
SECONDARY outcome
Timeframe: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injectionPopulation: All randomized subjects who received at least one dose of study drug
Pharmacokinetic parameter: Area under the glucagon concentration curve from 0 to 120 minutes
Outcome measures
| Measure |
G-Pen Mini™ (Glucagon Injection) 75 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart
|
G-Pen Mini™ (Glucagon Injection) 150 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart
|
G-Pen Mini™ (Glucagon Injection) 300 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart
|
|---|---|---|---|
|
Glucagon AUC (Post-insulin)
|
277.4 (pg/ml)*hour
Standard Error 29.9
|
386.8 (pg/ml)*hour
Standard Error 29.9
|
635.3 (pg/ml)*hour
Standard Error 29.7
|
SECONDARY outcome
Timeframe: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injectionPopulation: All randomized subjects who received at least one dose of study drug
Pharmacokinetic parameter: Time to reach maximum concentration of glucagon
Outcome measures
| Measure |
G-Pen Mini™ (Glucagon Injection) 75 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart
|
G-Pen Mini™ (Glucagon Injection) 150 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart
|
G-Pen Mini™ (Glucagon Injection) 300 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart
|
|---|---|---|---|
|
Glucagon Tmax (Fasting)
|
29.2 minutes
Standard Error 3.6
|
29.8 minutes
Standard Error 3.6
|
36.5 minutes
Standard Error 3.6
|
SECONDARY outcome
Timeframe: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injectionPopulation: All randomized subjects who received at least one dose of study drug
Pharmacokinetic parameter: Time to reach maximum concentration of glucagon
Outcome measures
| Measure |
G-Pen Mini™ (Glucagon Injection) 75 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart
|
G-Pen Mini™ (Glucagon Injection) 150 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart
|
G-Pen Mini™ (Glucagon Injection) 300 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart
|
|---|---|---|---|
|
Glucagon Tmax (Post-insulin)
|
24 minutes
Standard Error 2.7
|
33.1 minutes
Standard Error 2.7
|
34.1 minutes
Standard Error 2.7
|
SECONDARY outcome
Timeframe: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injectionPopulation: All randomized subjects who received at least one dose of study drug
Pharmacodynamic parameter: Maximum concentration of glucose
Outcome measures
| Measure |
G-Pen Mini™ (Glucagon Injection) 75 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart
|
G-Pen Mini™ (Glucagon Injection) 150 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart
|
G-Pen Mini™ (Glucagon Injection) 300 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart
|
|---|---|---|---|
|
Glucose Cmax (Fasting)
|
155.1 mg/dl
Standard Error 11.2
|
186.2 mg/dl
Standard Error 11.1
|
213.5 mg/dl
Standard Error 11.2
|
SECONDARY outcome
Timeframe: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injectionPopulation: All randomized subjects who received at least one dose of study drug
Pharmacodynamic parameter: Maximum concentration of glucose
Outcome measures
| Measure |
G-Pen Mini™ (Glucagon Injection) 75 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart
|
G-Pen Mini™ (Glucagon Injection) 150 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart
|
G-Pen Mini™ (Glucagon Injection) 300 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart
|
|---|---|---|---|
|
Glucose Cmax (Post-insulin)
|
99.7 mg/dl
Standard Error 8.6
|
105.7 mg/dl
Standard Error 8.6
|
122.6 mg/dl
Standard Error 8.4
|
SECONDARY outcome
Timeframe: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injectionPopulation: All randomized subjects who received at least one dose of study drug
Pharmacodynamic parameter: baseline adjusted area under the glucagon concentration curve from 0 to 120 minutes
Outcome measures
| Measure |
G-Pen Mini™ (Glucagon Injection) 75 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart
|
G-Pen Mini™ (Glucagon Injection) 150 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart
|
G-Pen Mini™ (Glucagon Injection) 300 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart
|
|---|---|---|---|
|
Glucose AUC (Fasting)
|
4872.0 (mg/dl)*minutes
Standard Error 1495.9
|
8565.2 (mg/dl)*minutes
Standard Error 1492.8
|
12420.0 (mg/dl)*minutes
Standard Error 1500.6
|
SECONDARY outcome
Timeframe: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injectionPopulation: All randomized subjects who received at least one dose of study drug
Pharmacodynamic parameter: baseline adjusted area under the glucose concentration curve from 0-120 minutes
Outcome measures
| Measure |
G-Pen Mini™ (Glucagon Injection) 75 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart
|
G-Pen Mini™ (Glucagon Injection) 150 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart
|
G-Pen Mini™ (Glucagon Injection) 300 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart
|
|---|---|---|---|
|
Glucose AUC (Post-insulin)
|
2263.2 (mg/dl)*minutes
Standard Error 717.1
|
2408.1 (mg/dl)*minutes
Standard Error 718.4
|
3928.5 (mg/dl)*minutes
Standard Error 703.4
|
SECONDARY outcome
Timeframe: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injectionPopulation: All randomized subjects who received at least one dose of study drug
Pharmacodynamic parameter: Time to reach maximum concentration of glucose
Outcome measures
| Measure |
G-Pen Mini™ (Glucagon Injection) 75 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart
|
G-Pen Mini™ (Glucagon Injection) 150 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart
|
G-Pen Mini™ (Glucagon Injection) 300 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart
|
|---|---|---|---|
|
Glucose Tmax (Fasting)
|
81.5 minutes
Standard Error 10.2
|
80.7 minutes
Standard Error 10.2
|
67.8 minutes
Standard Error 10.3
|
SECONDARY outcome
Timeframe: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injectionPopulation: All randomized subjects who received at least one dose of study drug
Pharmacodynamic parameter: Time to reach maximum concentration of glucose
Outcome measures
| Measure |
G-Pen Mini™ (Glucagon Injection) 75 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart
|
G-Pen Mini™ (Glucagon Injection) 150 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart
|
G-Pen Mini™ (Glucagon Injection) 300 ug
n=12 Participants
G-Pen Mini™ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart
|
|---|---|---|---|
|
Glucose Tmax (Post-insulin)
|
53.5 minutes
Standard Error 7.1
|
69.5 minutes
Standard Error 7.1
|
57.4 minutes
Standard Error 6.9
|
Adverse Events
G-Pen Mini™ (Glucagon Injection) 75 ug
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
G-Pen Mini™ (Glucagon Injection) 150 ug
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
G-Pen Mini™ (Glucagon Injection) 300 ug
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
G-Pen Mini™ (Glucagon Injection) 75 ug
n=12 participants at risk
G-Pen Mini™ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart
|
G-Pen Mini™ (Glucagon Injection) 150 ug
n=12 participants at risk
G-Pen Mini™ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart
|
G-Pen Mini™ (Glucagon Injection) 300 ug
n=12 participants at risk
G-Pen Mini™ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart
|
|---|---|---|---|
|
Eye disorders
blurred vision
|
8.3%
1/12 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/12
|
0.00%
0/12
|
33.3%
4/12 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
paresthesia
|
66.7%
8/12 • Number of events 13
|
66.7%
8/12 • Number of events 13
|
75.0%
9/12 • Number of events 16
|
|
Skin and subcutaneous tissue disorders
hypoesthesia
|
16.7%
2/12 • Number of events 2
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
nodule
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
pain
|
16.7%
2/12 • Number of events 3
|
16.7%
2/12 • Number of events 4
|
25.0%
3/12 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
bruising
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
erythema
|
50.0%
6/12 • Number of events 7
|
58.3%
7/12 • Number of events 7
|
50.0%
6/12 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
edema
|
16.7%
2/12 • Number of events 2
|
41.7%
5/12 • Number of events 5
|
33.3%
4/12 • Number of events 5
|
|
Injury, poisoning and procedural complications
hypoglycemia
|
16.7%
2/12 • Number of events 3
|
16.7%
2/12 • Number of events 2
|
8.3%
1/12 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
muscle twitching
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
headache
|
8.3%
1/12 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
pruritus
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
paresthesia
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Injury, poisoning and procedural complications
Skin reaction
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
Additional Information
Martin J. 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