Trial Outcomes & Findings for Glucagon Ready-to-Use (RTU) for Prevention of Exercise-Induced Hypoglycemia During Aerobic Exercise in Adults With T1D (NCT NCT03841526)

NCT ID: NCT03841526

Last Updated: 2025-08-22

Results Overview

Mean incidence rate of hypoglycemia during and after sessions of moderate to high intensity aerobic exercise in 12-week Outpatient Phase. Incidence rate is defined as the number of hypoglycemic events divided by the total number of qualified exercise sessions, assessed at group level. Qualified exercise session is: (1) confirmed blood glucose of 100-180 mg/dL prior to start of exercise, (2) self-administered study drug no more than 10 min prior to exercise (5 min target), (3) conducted a protocol allowed exercise of moderate to high intensity for at least 30 min and no longer than 75 min, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during session. Exercise sessions were to occur at least 2-3 times per week. Only 1 qualified exercise session/subject/day was included in the analysis (the first if \>1). Hypoglycemic event defined as any hypoglycemic event occurring within 30 (+2) min after completion of a qualified exercise session.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 48 participants
• Primary outcome timeframe: Daily; During the 12-week Outpatient Phase qualified exercise sessions were assessed daily and associated hypoglycemia events were assessed continuously during and within the 30 (+2) minute period following a qualified exercise session.
• Results posted on: 2025-08-22

Participant Flow

The study enrolled 48 subjects to participate in the study with a CRC phase followed by an Outpatient phase. The 45 subjects that completed the CRC phase were re-randomized prior to entering the Outpatient phase of the study.

Participant milestones

Measure	CRC: Glucagon RTU to Vehicle With 50% Reduction to Outpatient: Glucagon RTU With 50% Reduction CRC Phase (2-arm randomized double-blind crossover): Glucagon RTU Injection 0.15 mg injection with 50% reduction in the insulin pump to Vehicle for Glucagon RTU Injection with 50% reduction in the insulin pump to Outpatient Phase (3-arm randomized comparison, 2-arm double-blind, 1-arm open-label): Glucagon RTU Injection 0.15 mg injection with 50% reduction in the insulin pump (double-blind arm)	CRC: Glucagon RTU to Vehicle With 50% Reduction to Outpatient: Vehicle With 50% Reduction CRC Phase (2-arm randomized double-blind crossover): Glucagon RTU Injection 0.15 mg injection with 50% reduction in the insulin pump to Vehicle for Glucagon RTU Injection with 50% reduction in the insulin pump to Outpatient Phase (3-arm randomized comparison, 2-arm double-blind, 1-arm open-label): Vehicle for Glucagon RTU Injection with 50% reduction in the insulin pump (double-blind arm)	CRC: Glucagon RTU to Vehicle With 50% Reduction to Outpatient: Glucagon RTU Without Reduction CRC Phase (2-arm randomized double-blind crossover): Glucagon RTU Injection 0.15 mg injection with 50% reduction in the insulin pump to Vehicle for Glucagon RTU Injection with 50% reduction in the insulin pump to Outpatient Phase (3-arm randomized comparison, 2-arm double-blind, 1-arm open-label): Glucagon RTU Injection 0.15 mg injection without reduction in the insulin pump (open-label arm)	CRC: Vehicle to Glucagon RTU With 50% Reduction to Outpatient: Glucagon RTU With 50% Reduction CRC Phase (2-arm randomized double-blind crossover): Vehicle for Glucagon RTU Injection with 50% reduction in the insulin pump to Glucagon RTU Injection 0.15 mg injection with 50% reduction in the insulin pump to Outpatient Phase (3-arm randomized comparison, 2-arm double-blind, 1-arm open-label): Glucagon RTU Injection 0.15 mg injection with 50% reduction in the insulin pump (double-blind arm)	CRC: Vehicle to Glucagon RTU With 50% Reduction to Outpatient: Vehicle With 50% Reduction CRC Phase (2-arm randomized double-blind crossover): Vehicle for Glucagon RTU Injection with 50% reduction in the insulin pump to Glucagon RTU Injection 0.15 mg injection with 50% reduction in the insulin pump to Outpatient Phase (3-arm randomized comparison, 2-arm double-blind, 1-arm open-label): Vehicle for Glucagon RTU Injection with 50% reduction in the insulin pump (double-blind arm)	CRC: Vehicle to Glucagon RTU With 50% Reduction to Outpatient: Glucagon RTU Without Reduction CRC Phase (2-arm randomized double-blind crossover): Vehicle for Glucagon RTU Injection with 50% reduction in the insulin pump to Glucagon RTU Injection 0.15 mg injection with 50% reduction in the insulin pump to Outpatient Phase (3-arm randomized comparison, 2-arm double-blind, 1-arm open-label): Glucagon RTU Injection 0.15 mg injection without reduction in the insulin pump (open-label arm)
CRC Phase: First Treatment STARTED	8	10	6	11	5	8
CRC Phase: First Treatment Received 1st CRC Dose	8	10	6	11	5	8
CRC Phase: First Treatment COMPLETED	8	10	6	11	5	8
CRC Phase: First Treatment NOT COMPLETED	0	0	0	0	0	0
CRC Phase: Second Treatment STARTED	8	10	6	11	5	8
CRC Phase: Second Treatment Received 2nd CRC Dose	7	10	6	9	5	8
CRC Phase: Second Treatment COMPLETED	7	10	6	9	5	8
CRC Phase: Second Treatment NOT COMPLETED	1	0	0	2	0	0
Outpatient Phase Treatment STARTED	7	10	6	9	5	8
Outpatient Phase Treatment Received at Least 1 Outpatient Dose	7	9	6	9	5	8
Outpatient Phase Treatment COMPLETED	7	9	5	9	5	7
Outpatient Phase Treatment NOT COMPLETED	0	1	1	0	0	1

Reasons for withdrawal

Measure	CRC: Glucagon RTU to Vehicle With 50% Reduction to Outpatient: Glucagon RTU With 50% Reduction CRC Phase (2-arm randomized double-blind crossover): Glucagon RTU Injection 0.15 mg injection with 50% reduction in the insulin pump to Vehicle for Glucagon RTU Injection with 50% reduction in the insulin pump to Outpatient Phase (3-arm randomized comparison, 2-arm double-blind, 1-arm open-label): Glucagon RTU Injection 0.15 mg injection with 50% reduction in the insulin pump (double-blind arm)	CRC: Glucagon RTU to Vehicle With 50% Reduction to Outpatient: Vehicle With 50% Reduction CRC Phase (2-arm randomized double-blind crossover): Glucagon RTU Injection 0.15 mg injection with 50% reduction in the insulin pump to Vehicle for Glucagon RTU Injection with 50% reduction in the insulin pump to Outpatient Phase (3-arm randomized comparison, 2-arm double-blind, 1-arm open-label): Vehicle for Glucagon RTU Injection with 50% reduction in the insulin pump (double-blind arm)	CRC: Glucagon RTU to Vehicle With 50% Reduction to Outpatient: Glucagon RTU Without Reduction CRC Phase (2-arm randomized double-blind crossover): Glucagon RTU Injection 0.15 mg injection with 50% reduction in the insulin pump to Vehicle for Glucagon RTU Injection with 50% reduction in the insulin pump to Outpatient Phase (3-arm randomized comparison, 2-arm double-blind, 1-arm open-label): Glucagon RTU Injection 0.15 mg injection without reduction in the insulin pump (open-label arm)	CRC: Vehicle to Glucagon RTU With 50% Reduction to Outpatient: Glucagon RTU With 50% Reduction CRC Phase (2-arm randomized double-blind crossover): Vehicle for Glucagon RTU Injection with 50% reduction in the insulin pump to Glucagon RTU Injection 0.15 mg injection with 50% reduction in the insulin pump to Outpatient Phase (3-arm randomized comparison, 2-arm double-blind, 1-arm open-label): Glucagon RTU Injection 0.15 mg injection with 50% reduction in the insulin pump (double-blind arm)	CRC: Vehicle to Glucagon RTU With 50% Reduction to Outpatient: Vehicle With 50% Reduction CRC Phase (2-arm randomized double-blind crossover): Vehicle for Glucagon RTU Injection with 50% reduction in the insulin pump to Glucagon RTU Injection 0.15 mg injection with 50% reduction in the insulin pump to Outpatient Phase (3-arm randomized comparison, 2-arm double-blind, 1-arm open-label): Vehicle for Glucagon RTU Injection with 50% reduction in the insulin pump (double-blind arm)	CRC: Vehicle to Glucagon RTU With 50% Reduction to Outpatient: Glucagon RTU Without Reduction CRC Phase (2-arm randomized double-blind crossover): Vehicle for Glucagon RTU Injection with 50% reduction in the insulin pump to Glucagon RTU Injection 0.15 mg injection with 50% reduction in the insulin pump to Outpatient Phase (3-arm randomized comparison, 2-arm double-blind, 1-arm open-label): Glucagon RTU Injection 0.15 mg injection without reduction in the insulin pump (open-label arm)
CRC Phase: Second Treatment Withdrawal by Subject	1	0	0	1	0	0
CRC Phase: Second Treatment Adverse Event	0	0	0	1	0	0
Outpatient Phase Treatment Physician Decision	0	1	0	0	0	0
Outpatient Phase Treatment Withdrawal by Subject	0	0	1	0	0	1

Baseline Characteristics

Glucagon Ready-to-Use (RTU) for Prevention of Exercise-Induced Hypoglycemia During Aerobic Exercise in Adults With T1D

Baseline characteristics by cohort

Measure	Glucagon RTU Crossover to Placebo n=24 Participants CRC Stage: Glucagon RTU to Placebo Crossover Group (Glucagon RTU Injection 30 microliters of 0.15 mg injection crossover to vehicle injection of 30 microliters) with 50% reduction in the insulin pump	Placebo Crossover to Glucagon RTU n=24 Participants CRC Stage: Placebo to Glucagon RTU Crossover Group (vehicle injection of 30 microliters crossover to Glucagon RTU Injection 30 microliters of 0.15 mg injection) with 50% reduction in the insulin pump	Total n=48 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	24 Participants n=5 Participants	24 Participants n=7 Participants	48 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	39.8 years STANDARD_DEVIATION 11.47 • n=5 Participants	34.7 years STANDARD_DEVIATION 10.54 • n=7 Participants	37.3 years STANDARD_DEVIATION 11.20 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	14 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants	22 Participants n=7 Participants	46 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	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	20 Participants n=7 Participants	39 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	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants	24 participants n=7 Participants	48 participants n=5 Participants
Weight	82.15 kg STANDARD_DEVIATION 16.344 • n=5 Participants	75.91 kg STANDARD_DEVIATION 16.769 • n=7 Participants	79.03 kg STANDARD_DEVIATION 16.681 • n=5 Participants
BMI	27.051 kg/m^2 STANDARD_DEVIATION 4.6277 • n=5 Participants	26.515 kg/m^2 STANDARD_DEVIATION 4.7469 • n=7 Participants	26.783 kg/m^2 STANDARD_DEVIATION 4.6454 • n=5 Participants

PRIMARY outcome

Timeframe: Daily; During the 12-week Outpatient Phase qualified exercise sessions were assessed daily and associated hypoglycemia events were assessed continuously during and within the 30 (+2) minute period following a qualified exercise session.

Population: All randomized subjects in the Outpatient Phase with data.

Mean incidence rate of hypoglycemia during and after sessions of moderate to high intensity aerobic exercise in 12-week Outpatient Phase. Incidence rate is defined as the number of hypoglycemic events divided by the total number of qualified exercise sessions, assessed at group level.

Qualified exercise session is: (1) confirmed blood glucose of 100-180 mg/dL prior to start of exercise, (2) self-administered study drug no more than 10 min prior to exercise (5 min target), (3) conducted a protocol allowed exercise of moderate to high intensity for at least 30 min and no longer than 75 min, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during session.

Exercise sessions were to occur at least 2-3 times per week. Only 1 qualified exercise session/subject/day was included in the analysis (the first if >1).

Hypoglycemic event defined as any hypoglycemic event occurring within 30 (+2) min after completion of a qualified exercise session.

Outcome measures

Measure	Outpatient Phase: Glucagon RTU With Insulin Pump Reduction n=16 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection with 50% reduction in the insulin pump (double-blind arm)	Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction n=14 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Vehicle for Glucagon RTU Injection 30 microliters vehicle with 50% reduction in the insulin pump (double-blind arm)	Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction n=14 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-amr open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection without a reduction in the insulin pump (open-label arm)	Outpatient Phase: Overall n=44 Participants All 3 treatment groups in the Outpatient Phase
Outpatient Phase: Incidence Rate of Hypoglycemia During and After Moderate to High Intensity Aerobic Exercise.	0.12 events/session	0.39 events/session	0.16 events/session	0.24 events/session

PRIMARY outcome

Timeframe: Daily; During the 12-week Outpatient Phase qualified exercise sessions were assessed daily and associated hypoglycemia events were assessed continuously throughout the 30 (+2) minute period following a qualified exercise session.

Population: All randomized subjects in the Outpatient Phase with data.

Outpatient Phase: Mean number of hypoglycemic events associated with the qualified exercise sessions, assessed at group level.

A qualified exercise session was defined as one were (1) a confirmed blood glucose value of 100-180 mg/dL prior to start of exercise, (2) self-administered the study drug no more than 10 minutes prior to exercise (5 minutes was the target), (3) conducted a protocol allowed exercise for moderate to high intensity for at least 30 minutes and no longer than 75 minutes, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during the session.

A hypoglycemic event was defined as any hypoglycemic event occurring during or within 30 (+2) minutes after completion of a qualified exercise session.

Exercise sessions were expected to occur at least 2 to 3 times per week. Only 1 qualified exercise session per subject per day was included in the analysis (the first if >1).

Outcome measures

Measure	Outpatient Phase: Glucagon RTU With Insulin Pump Reduction n=16 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection with 50% reduction in the insulin pump (double-blind arm)	Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction n=14 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Vehicle for Glucagon RTU Injection 30 microliters vehicle with 50% reduction in the insulin pump (double-blind arm)	Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction n=14 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-amr open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection without a reduction in the insulin pump (open-label arm)	Outpatient Phase: Overall n=44 Participants All 3 treatment groups in the Outpatient Phase
Outpatient Phase: Mean Number of Hypoglycemic Events	1.94 mean number of events/participant	8.43 mean number of events/participant	2.86 mean number of events/participant	4.3 mean number of events/participant

PRIMARY outcome

Timeframe: Daily; During the 12-week Outpatient Phase the occurrence of qualified exercise sessions were assessed daily.

Population: All randomized subjects in the Outpatient Phase with data.

Outpatient Phase: Mean number of qualified exercise sessions, assessed at group level.

A qualified exercise session was defined as one were (1) a confirmed blood glucose value of 100-180 mg/dL prior to start of exercise, (2) self-administered the study drug no more than 10 minutes prior to exercise (5 minutes was the target), (3) conducted a protocol allowed exercise for moderate to high intensity for at least 30 minutes and no longer than 75 minutes, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during the session.

Exercise sessions were expected to occur at least 2 to 3 times per week. Only 1 qualified exercise session per subject per day was included in the analysis (the first if >1).

Outcome measures

Measure	Outpatient Phase: Glucagon RTU With Insulin Pump Reduction n=16 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection with 50% reduction in the insulin pump (double-blind arm)	Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction n=14 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Vehicle for Glucagon RTU Injection 30 microliters vehicle with 50% reduction in the insulin pump (double-blind arm)	Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction n=14 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-amr open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection without a reduction in the insulin pump (open-label arm)	Outpatient Phase: Overall n=44 Participants All 3 treatment groups in the Outpatient Phase
Outpatient Phase: Mean Number of Qualified High Intensity Aerobic Exercise Sessions	15.69 mean number of sessions/participant	21.64 mean number of sessions/participant	17.36 mean number of sessions/participant	18.11 mean number of sessions/participant

SECONDARY outcome

Timeframe: Visit 3 (Day 1) and Visit 4 (Day 3 or any day up to Day 29); Assessed continuously 0-300 minutes following the start of the exercise session corresponding to each of the treatments during the corresponding in-clinic visit during the CRC Phase.

Population: All randomized subjects in the CRC phase.

Analysis of interstitial glucose (IG) was performed by treatment, independent of the order of treatment during the randomized cross-over CRC Phase. The number of participants are categorized by the following IG levels:

Below range, as defined by IG <= 70 mg/dl (<=3.89 mmol/L); Between range, as defined by IG between 54 to 70 mg/dL (3 to 3.89 mmol/L); Below range, as defined by IG <54 mg/dL (<3 mmol/L)

Outcome measures

Measure	Outpatient Phase: Glucagon RTU With Insulin Pump Reduction n=48 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection with 50% reduction in the insulin pump (double-blind arm)	Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction n=48 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Vehicle for Glucagon RTU Injection 30 microliters vehicle with 50% reduction in the insulin pump (double-blind arm)	Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction n=48 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-amr open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection without a reduction in the insulin pump (open-label arm)	Outpatient Phase: Overall All 3 treatment groups in the Outpatient Phase
CRC Phase: Interstitial Glucose Below Target Range Below range (<=70 mg/dL)	4 Participants	5 Participants	9 Participants	—
CRC Phase: Interstitial Glucose Below Target Range Between range (54-70 mg/dL)	4 Participants	5 Participants	9 Participants	—
CRC Phase: Interstitial Glucose Below Target Range Below range (<54 mg/dL)	1 Participants	1 Participants	2 Participants	—

SECONDARY outcome

Timeframe: Visit 3 (Day 1) and Visit 4 (Day 3 or any day up to Day 29); Assessed continuously 0-300 minutes following the start of each qualified exercise session corresponding to each of the treatments during the Outpatient Phase.

Population: All randomized subjects in the Outpatient Phase with data.

Analysis of interstitial glucose (IG) was performed by treatment, during the randomized Outpatient Phase. The number of participants are categorized by the following IG levels:

Below range, as defined by IG <= 70 mg/dl (<=3.89 mmol/L); Between range, as defined by IG between 54 to 70 mg/dL (3 to 3.89 mmol/L); Below range, as defined by IG <54 mg/dL (<3 mmol/L)

Outcome measures

Measure	Outpatient Phase: Glucagon RTU With Insulin Pump Reduction n=16 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection with 50% reduction in the insulin pump (double-blind arm)	Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction n=15 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Vehicle for Glucagon RTU Injection 30 microliters vehicle with 50% reduction in the insulin pump (double-blind arm)	Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction n=14 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-amr open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection without a reduction in the insulin pump (open-label arm)	Outpatient Phase: Overall n=45 Participants All 3 treatment groups in the Outpatient Phase
Outpatient Phase: Interstitial Glucose Levels Below Target Range Below range <=70 mg/dL	14 Participants	14 Participants	12 Participants	40 Participants
Outpatient Phase: Interstitial Glucose Levels Below Target Range Between Range 54-70 mg/dL	14 Participants	14 Participants	12 Participants	40 Participants
Outpatient Phase: Interstitial Glucose Levels Below Target Range Below range <54 mg/dL	11 Participants	14 Participants	9 Participants	34 Participants

SECONDARY outcome

Timeframe: Insulin use measured continuously from Study Baseline to End of Study and assessed during Outpatient Phase as Change from Outpatient Phase Baseline at Study Weeks 4, 8, and 12

Population: All randomized subjects in the Outpatient Phase with change from Outpatient Phase Baseline data available at Study Weeks 4, 8, and 12

Insulin use as reported by subject as Change from Outpatient Phase Baseline at Study Weeks 4, 8, and 12

Outcome measures

Measure	Outpatient Phase: Glucagon RTU With Insulin Pump Reduction n=11 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection with 50% reduction in the insulin pump (double-blind arm)	Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction n=12 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Vehicle for Glucagon RTU Injection 30 microliters vehicle with 50% reduction in the insulin pump (double-blind arm)	Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction n=7 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-amr open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection without a reduction in the insulin pump (open-label arm)	Outpatient Phase: Overall All 3 treatment groups in the Outpatient Phase
Outpatient Phase: Insulin Use Change From Baseline NovoRapid (Insulin Aspart) - Change from Baseline at Week 4	-2.43 units of insulin Standard Deviation 1.559	-1.57 units of insulin Standard Deviation 2.558	-2.85 units of insulin Standard Deviation 3.041	—
Outpatient Phase: Insulin Use Change From Baseline Fiasp (Insluin Aspart) - Change from Baseline at Week 4	-2.80 units of insulin	2.60 units of insulin Standard Deviation 0.141	0.10 units of insulin	—
Outpatient Phase: Insulin Use Change From Baseline Fiasp (Insluin Aspart) - Change from Baseline at Week 8	—	-2.10 units of insulin Standard Deviation 1.353	—	—
Outpatient Phase: Insulin Use Change From Baseline Fiasp (Insluin Aspart) - Change from Baseline at Week 12	-7.60 units of insulin	-1.70 units of insulin Standard Deviation 4.808	—	—
Outpatient Phase: Insulin Use Change From Baseline Humalog (Insulin Lispro) - Change from Baseline at Week 4	—	3.05 units of insulin Standard Deviation 1.909	6.20 units of insulin	—
Outpatient Phase: Insulin Use Change From Baseline Humalog (Insulin Lispro) - Change from Baseline at Week 8	0.90 units of insulin	7.20 units of insulin	3.20 units of insulin Standard Deviation 9.758	—
Outpatient Phase: Insulin Use Change From Baseline Humalog (Insulin Lispro) - Change from Baseline at Week 12	0.60 units of insulin	1.05 units of insulin Standard Deviation 3.041	-0.85 units of insulin Standard Deviation 5.498	—
Outpatient Phase: Insulin Use Change From Baseline NovoRapid (Insulin Aspart) - Change from Baseline at Week 8	-0.15 units of insulin Standard Deviation 3.901	-2.85 units of insulin Standard Deviation 3.834	—	—
Outpatient Phase: Insulin Use Change From Baseline NovoRapid (Insulin Aspart) - Change from Baseline at Week 12	-0.05 units of insulin Standard Deviation 10.872	-4.20 units of insulin	—	—

SECONDARY outcome

Timeframe: Baseline to End of Study measured at Outpatient Phase Baseline (Visit 3, Day 1) and Follow-up (Visit 11, 14-21 days after last exercise session, up to Day 134) or Early Termination (at time of discontinuation)

Population: All randomized subjects in the Outpatient Phase with data.

Change from Baseline to End of the Outpatient Phase in Score on Barriers to Physical Activity in Type 1 Diabetes (BAPAD-1) Questionnaire A total of 12 factors were scored from 1=unlikely (min.) to 7=extremely likely (max.) for their propensity to keep the subject from practicing regular physical exercise during the next 6 months. Lower scores are considered better, while higher scores are considered worse outcomes. The higher the score (1 to 7), the less likely the subject was to engage in exercise.

The mean of the scores of the 12 factors were calculated for each subject and the overall mean for the subjects was calculated at a group level with overall mean and standard deviation calculated at Baseline (Visit 3) and Follow-up/Early Termination (Visit 11) to calculate change from Baseline. Subject level and overall means could range from 1 to 7.

Outcome measures

Measure	Outpatient Phase: Glucagon RTU With Insulin Pump Reduction n=16 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection with 50% reduction in the insulin pump (double-blind arm)	Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction n=15 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Vehicle for Glucagon RTU Injection 30 microliters vehicle with 50% reduction in the insulin pump (double-blind arm)	Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction n=14 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-amr open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection without a reduction in the insulin pump (open-label arm)	Outpatient Phase: Overall All 3 treatment groups in the Outpatient Phase
Outpatient Phase: Barriers to Physical Activity Diabetes (Type 1): BAPAD-1 Change From Baseline Baseline BAPAD-1 (Study Visit 3)	2.25 score on a scale Standard Deviation 0.894	2.17 score on a scale Standard Deviation 0.857	2.59 score on a scale Standard Deviation 0.957	—
Outpatient Phase: Barriers to Physical Activity Diabetes (Type 1): BAPAD-1 Change From Baseline Change from Baseline at Follow-up in BAPAD-1 (Study Visit 11)	0.01 score on a scale Standard Deviation 0.988	-0.38 score on a scale Standard Deviation 0.781	-0.34 score on a scale Standard Deviation 0.890	—
Outpatient Phase: Barriers to Physical Activity Diabetes (Type 1): BAPAD-1 Change From Baseline Change from Baseline at Early Termination in BAPAD-1	—	—	-1.00 score on a scale Standard Deviation 0.141	—

SECONDARY outcome

Timeframe: Baseline to End of Study measured at Outpatient Phase Baseline (Visit 3, Day 1) and Follow-up (Visit 11, 14-21 days after last exercise session, up to Day 134) or Early Termination (at time of discontinuation)

Population: All randomized subjects in the Outpatient Phase with data.

Change from Baseline in Score on Hypoglycemia Fear Survey-II (HFS-II)

A total of 33 items were scored from 0=never (min.) to 4=almost always (max.) for how often in the past 6 months they had done the following:

Behavior (15 items): things that people with diabetes often do to avoid low blood sugar.

Worry (18 items): things that people with diabetes often worry about because of low blood sugar.

Lower scores are considered better outcomes, higher scores are considered worse outcomes.

The higher the score (0 to 4), the greater the subject's fear of hypoglycemia. The mean of the scores of the 33 items were calculated for each subject and the overall mean for the subjects was calculated at a group level with overall mean and standard deviation calculated at Baseline (Visit 3) and Follow-up/Early Termination (Visit 11) to calculate change from Baseline. Subject level and overall means could range from 0 to 4.

Outcome measures

Measure	Outpatient Phase: Glucagon RTU With Insulin Pump Reduction n=16 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection with 50% reduction in the insulin pump (double-blind arm)	Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction n=15 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Vehicle for Glucagon RTU Injection 30 microliters vehicle with 50% reduction in the insulin pump (double-blind arm)	Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction n=14 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-amr open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection without a reduction in the insulin pump (open-label arm)	Outpatient Phase: Overall All 3 treatment groups in the Outpatient Phase
Outpatient Phase: HFS-II Overall Score Change From Baseline Baseline	1.28 score on a scale Standard Deviation 0.293	1.16 score on a scale Standard Deviation 0.479	1.50 score on a scale Standard Deviation 0.746	—
Outpatient Phase: HFS-II Overall Score Change From Baseline Change from Baseline at Follow-up (Visit 11)	-0.19 score on a scale Standard Deviation 0.424	-0.01 score on a scale Standard Deviation 0.290	-0.03 score on a scale Standard Deviation 0.280	—
Outpatient Phase: HFS-II Overall Score Change From Baseline Change from Baseline at Early Termination	—	—	-0.60 score on a scale Standard Deviation 0.849	—

SECONDARY outcome

Timeframe: Baseline to End of Study measured at Outpatient Phase Baseline (Visit 3, Day 1) and Follow-up (Visit 11, 14-21 days after last exercise session, up to Day 134) or Early Termination (at time of discontinuation)

Population: All randomized subjects in the Outpatient Phase with data.

Change from Baseline in Score on Hypoglycemia Confidence Scale (HCS)

The 9-item scale assessed a subject's confidence about safety regarding hypoglycemia. The questionnaire had 4 responses possible for each question, ranging from 1=not confident at all (min.) to 4=very confident (max.). Higher scores are considered better outcomes, while lower scores are considered worse outcomes. The lower the score (1 to 4), the less likely the subject was to engage in exercise.

The mean of the scores of the 9 items were calculated for each subject and the overall mean for the subjects was calculated at a group level with overall mean and standard deviation calculated at Baseline (Visit 3) and Follow-up/Early Termination (Visit 11) to calculate change from Baseline. Subject level and overall means could range from 1 to 4.

Outcome measures

Measure	Outpatient Phase: Glucagon RTU With Insulin Pump Reduction n=16 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection with 50% reduction in the insulin pump (double-blind arm)	Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction n=15 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Vehicle for Glucagon RTU Injection 30 microliters vehicle with 50% reduction in the insulin pump (double-blind arm)	Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction n=14 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-amr open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection without a reduction in the insulin pump (open-label arm)	Outpatient Phase: Overall All 3 treatment groups in the Outpatient Phase
Outpatient Phase: Hypoglycemic Confidence Scale (HCS) Change From Baseline Baseline	3.23 score on a scale Standard Deviation 0.541	3.34 score on a scale Standard Deviation 0.616	3.20 score on a scale Standard Deviation 0.447	—
Outpatient Phase: Hypoglycemic Confidence Scale (HCS) Change From Baseline Change from Baseline at Follow-up (Visit 11)	0.07 score on a scale Standard Deviation 0.413	0.17 score on a scale Standard Deviation 0.298	0.20 score on a scale Standard Deviation 0.357	—
Outpatient Phase: Hypoglycemic Confidence Scale (HCS) Change From Baseline Change from Baseline at Early Termination	—	—	0.15 score on a scale Standard Deviation 0.778	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Visit 3 (Day 1) and Visit 4 (Day 3 or any day up to Day 29); At each visit, the associated hypoglycemia events were assessed continuously throughout the 30 (+2) minute period following a qualified exercise session.

Population: All randomized subjects in the CRC Phase.

Mean incidence rate of hypoglycemia during or after moderate to high intensity aerobic exercise at each CRC Phase visit. With crossover, each subject had 2 exercise sessions; 1 visit and exercise session with each treatment (the combined data are presented in the Overall category) and assessed at the group level.

Incidence rate is defined as the number of hypoglycemic events divided by the total number of qualified exercise sessions, assessed at group level.

Qualified exercise session is: (1) confirmed blood glucose of 100-180 mg/dL prior to start of exercise, (2) study drug administered no more than 10 min prior to exercise (5 min target), (3) conducted exercise of moderate to high intensity for at least 30 min and no longer than 75 min, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during session.

Hypoglycemic event defined as any hypoglycemic event occurring within 30 (+2) min after completion of a qualified exercise session.

Outcome measures

Measure	Outpatient Phase: Glucagon RTU With Insulin Pump Reduction n=46 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection with 50% reduction in the insulin pump (double-blind arm)	Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction n=47 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Vehicle for Glucagon RTU Injection 30 microliters vehicle with 50% reduction in the insulin pump (double-blind arm)	Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction n=48 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-amr open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection without a reduction in the insulin pump (open-label arm)	Outpatient Phase: Overall All 3 treatment groups in the Outpatient Phase
CRC Phase: Incidence Rate of Hypoglycemia During and After Moderate to High Intensity Aerobic Exercise Exercise.	0.02 events/session	0.19 events/session	0.11 events/session	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Visit 3 (Day 1) and Visit 4 (Day 3 or any day up to Day 29); At each visit, the associated hypoglycemia events were assessed continuously throughout the 30 (+2) minute period following a qualified exercise session.

Population: All randomized subjects in the CRC Phase.

CRC Phase: Mean number of hypoglycemic events associated with the qualified exercise sessions at each CRC Phase visit. With crossover, each subject had 2 exercise sessions; 1 visit and exercise session with each treatment (the combined data are presented in the Overall category) assessed at group level.

A qualified exercise session is: (1) confirmed blood glucose of 100-180 mg/dL prior to start of exercise, (2) study drug administered no more than 10 min prior to exercise (5 min target), (3) conducted exercise of moderate to high intensity for at least 30 min and no longer than 75 min, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during session.

A hypoglycemic event defined as any hypoglycemic event occurring within 30 (+2) min after completion of a qualified exercise session.

Outcome measures

Measure	Outpatient Phase: Glucagon RTU With Insulin Pump Reduction n=46 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection with 50% reduction in the insulin pump (double-blind arm)	Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction n=47 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Vehicle for Glucagon RTU Injection 30 microliters vehicle with 50% reduction in the insulin pump (double-blind arm)	Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction n=48 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-amr open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection without a reduction in the insulin pump (open-label arm)	Outpatient Phase: Overall All 3 treatment groups in the Outpatient Phase
CRC Phase: Mean Number of Hypoglycemic Events Exercise.	0.02 number of events/participant	0.19 number of events/participant	0.21 number of events/participant	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Visit 3 (Day 1) and Visit 4 (Day 3 or any day up to Day 29); At each visit, the number of qualified exercise sessions that occurred.

Population: All randomized subjects in the CRC Phase.

Mean number of high intensity aerobic exercise sessions at each CRC Phase visit. With crossover, each subject was to have 2 exercise sessions; 1 visit and exercise session with each treatment (the combined data are presented in the Overall category) and assessed at the group level.

A qualified exercise session was defined as one where (1) confirmed blood glucose of 100-180 mg/dL prior to start of exercise, (2) study drug administered no more than 10 min prior to exercise (5 min target), (3) conducted exercise of moderate to high intensity for at least 30 min and no longer than 75 min, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during session.

Outcome measures

Measure	Outpatient Phase: Glucagon RTU With Insulin Pump Reduction n=46 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection with 50% reduction in the insulin pump (double-blind arm)	Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction n=47 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Vehicle for Glucagon RTU Injection 30 microliters vehicle with 50% reduction in the insulin pump (double-blind arm)	Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction n=48 Participants Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-amr open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection without a reduction in the insulin pump (open-label arm)	Outpatient Phase: Overall All 3 treatment groups in the Outpatient Phase
CRC Phase: Mean Number of Qualified High Intensity Aerobic Exercise Sessions	1 mean number of sessions/participant	1 mean number of sessions/participant	1.94 mean number of sessions/participant	—

Adverse Events

CRC Phase: Glucagon RTU With Insulin Pump Reduction

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

CRC Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Outpatient Phase: Glucagon RTU With Insulin Pump Reduction

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	CRC Phase: Glucagon RTU With Insulin Pump Reduction n=46 participants at risk CRC Phase: 2-arm randomized double-blind crossover, Glucagon RTU Injection 30 microliters of 0.15 mg injection with 50% reduction in the insulin pump	CRC Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction n=47 participants at risk CRC Phase: 2-arm randomized double-blind crossover, Vehicle for Glucagon RTU Injection 30 microliters vehicle with 50% reduction in insulin pump	Outpatient Phase: Glucagon RTU With Insulin Pump Reduction n=16 participants at risk Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection with 50% reduction in the insulin pump (double-blind arm)	Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction n=14 participants at risk Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Vehicle for Glucagon RTU Injection 30 microliters vehicle with 50% reduction in insulin pump (double-blind arm)	Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction n=14 participants at risk Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection without a reduction in the insulin pump (open-label arm)
General disorders Injection site pain	32.6% 15/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	38.3% 18/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	37.5% 6/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	57.1% 8/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	21.4% 3/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
General disorders Injection site discomfort	8.7% 4/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	2.1% 1/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	6.2% 1/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	7.1% 1/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	7.1% 1/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
General disorders Injection site irritation	2.2% 1/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	6.4% 3/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	7.1% 1/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
General disorders Injection site reaction	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	6.4% 3/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	7.1% 1/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
General disorders Injection site paresthesia	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	2.1% 1/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	6.2% 1/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
General disorders Application site erythema	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	7.1% 1/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
General disorders Application site rash	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	6.2% 1/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
General disorders Injection site haematoma	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	7.1% 1/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
General disorders Injection site haemorrhage	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	7.1% 1/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
General disorders Malaise	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	6.2% 1/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Nervous system disorders Dizziness	8.7% 4/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	2.1% 1/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	6.2% 1/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	7.1% 1/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Nervous system disorders Carpal tunnel syndrome	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	7.1% 1/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Infections and infestations Upper respiratory tract infection	2.2% 1/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	4.3% 2/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	6.2% 1/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	14.3% 2/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Infections and infestations Nasopharyngitis	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	4.3% 2/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	7.1% 1/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	14.3% 2/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Infections and infestations Urinary tract infection	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	2.1% 1/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	6.2% 1/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	14.3% 2/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Infections and infestations Gastroenteritis viral	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	6.2% 1/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	7.1% 1/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	7.1% 1/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Infections and infestations Ear infection	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	6.2% 1/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Infections and infestations Gastroenteritis	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	7.1% 1/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Infections and infestations Influenza	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	7.1% 1/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Infections and infestations Onychomycosis	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	7.1% 1/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Infections and infestations Tinea pedis	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	7.1% 1/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Gastrointestinal disorders Nausea	4.3% 2/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	2.1% 1/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	12.5% 2/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	7.1% 1/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	14.3% 2/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Injury, poisoning and procedural complications Abdominal distension	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	2.1% 1/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	6.2% 1/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Gastrointestinal disorders Vomiting	2.2% 1/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	6.2% 1/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	14.3% 2/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Gastrointestinal disorders Abdominal discomfort	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	7.1% 1/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Gastrointestinal disorders Flatulence	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	6.2% 1/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Skin and subcutaneous tissue disorders Toothache	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	7.1% 1/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	7.1% 1/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	6.2% 1/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	6.2% 1/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Injury, poisoning and procedural complications Fall	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	14.3% 2/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	7.1% 1/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Injury, poisoning and procedural complications Muscle strain	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	6.2% 1/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Injury, poisoning and procedural complications Procedural pain	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	6.2% 1/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	14.3% 2/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	14.3% 2/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Metabolism and nutrition disorders Decreased appetiate	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	6.2% 1/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Skin and subcutaneous tissue disorders Anhidrosis	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	7.1% 1/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	6.2% 1/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	7.1% 1/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Skin and subcutaneous tissue disorders Rash	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	6.2% 1/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	6.2% 1/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	7.1% 1/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Reproductive system and breast disorders Metrorrhagia	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	6.2% 1/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Investigations Weight increased	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	7.1% 1/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Psychiatric disorders Depression	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	7.1% 1/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/46 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/47 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/16 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	0.00% 0/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).	7.1% 1/14 • From signing of Informed Consent Form through the followup visit (week 12) Adverse events were reported and summarized separately for the 2 phases of the study (CRC Phase and Outpatient Phase).

Additional Information

Dawn Harper, VP Clinical Devlopment

Xeris Pharmaceuticals

Phone: 1-877-XERIS-37

Email: clinicaltrials@xerispharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place