Trial Outcomes & Findings for Phase 2, Randomized, Open-Label, Crossover, PD/PK Study of a Novel Pram-Insulin Co-Formulation in Adults With T1D (NCT NCT04074317)
NCT ID: NCT04074317
Last Updated: 2024-03-27
Results Overview
The PD effects on plasma glucose levels were compared among the treatment arms as defined by AUC0-180 (mg/dL \* minutes) for plasma glucose \>180 mg/dL
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
0-180 minutes following administration of study drug
Results posted on
2024-03-27
Participant Flow
The study was a 3-treatment, 6-sequence, 3-period crossover design where 18 eligible subjects randomized to 6 treatment sequences (3 subjects per sequence), with each subject scheduled to receive all 3 treatments.
Participant milestones
| Measure |
PRAM9 to Regular Insulin to Regular Insulin+Pramlintide
PRAM9 (Xeris pramlintide + insulin co-formulation): SC injection Regular Insulin (Humulin®): SC injection Regular Insulin (Humulin®) + Pramlintide (Symlin®): Separate SC injections
|
Regular Insulin to Regular Insulin+Pramlintide to PRAM9
PRAM9 (Xeris pramlintide + insulin co-formulation): SC injection Regular Insulin (Humulin®): SC injection Regular Insulin (Humulin®) + Pramlintide (Symlin®): Separate SC injections
|
Regular Insulin+Pramlintide to PRAM9 to Regular Insulin
PRAM9 (Xeris pramlintide + insulin co-formulation): SC injection Regular Insulin (Humulin®): SC injection Regular Insulin (Humulin®) + Pramlintide (Symlin®): Separate SC injections
|
PRAM9 to Regular Insulin+Pramlintide to Regular Insulin
PRAM9 (Xeris pramlintide + insulin co-formulation): SC injection Regular Insulin (Humulin®): SC injection Regular Insulin (Humulin®) + Pramlintide (Symlin®): Separate SC injections
|
Regular Insulin to PRAM9 to Regular Insulin+Pramlintide
PRAM9 (Xeris pramlintide + insulin co-formulation): SC injection Regular Insulin (Humulin®): SC injection Regular Insulin (Humulin®) + Pramlintide (Symlin®): Separate SC injections
|
Regular Insulin+Pramlintide to Regular Insulin to PRAM9
PRAM9 (Xeris pramlintide + insulin co-formulation): SC injection Regular Insulin (Humulin®): SC injection Regular Insulin (Humulin®) + Pramlintide (Symlin®): Separate SC injections
|
|---|---|---|---|---|---|---|
|
First Period
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
First Period
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
First Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Period
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Second Period
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Second Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Period
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Third Period
COMPLETED
|
3
|
3
|
3
|
2
|
3
|
3
|
|
Third Period
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
PRAM9 to Regular Insulin to Regular Insulin+Pramlintide
PRAM9 (Xeris pramlintide + insulin co-formulation): SC injection Regular Insulin (Humulin®): SC injection Regular Insulin (Humulin®) + Pramlintide (Symlin®): Separate SC injections
|
Regular Insulin to Regular Insulin+Pramlintide to PRAM9
PRAM9 (Xeris pramlintide + insulin co-formulation): SC injection Regular Insulin (Humulin®): SC injection Regular Insulin (Humulin®) + Pramlintide (Symlin®): Separate SC injections
|
Regular Insulin+Pramlintide to PRAM9 to Regular Insulin
PRAM9 (Xeris pramlintide + insulin co-formulation): SC injection Regular Insulin (Humulin®): SC injection Regular Insulin (Humulin®) + Pramlintide (Symlin®): Separate SC injections
|
PRAM9 to Regular Insulin+Pramlintide to Regular Insulin
PRAM9 (Xeris pramlintide + insulin co-formulation): SC injection Regular Insulin (Humulin®): SC injection Regular Insulin (Humulin®) + Pramlintide (Symlin®): Separate SC injections
|
Regular Insulin to PRAM9 to Regular Insulin+Pramlintide
PRAM9 (Xeris pramlintide + insulin co-formulation): SC injection Regular Insulin (Humulin®): SC injection Regular Insulin (Humulin®) + Pramlintide (Symlin®): Separate SC injections
|
Regular Insulin+Pramlintide to Regular Insulin to PRAM9
PRAM9 (Xeris pramlintide + insulin co-formulation): SC injection Regular Insulin (Humulin®): SC injection Regular Insulin (Humulin®) + Pramlintide (Symlin®): Separate SC injections
|
|---|---|---|---|---|---|---|
|
Third Period
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Phase 2, Randomized, Open-Label, Crossover, PD/PK Study of a Novel Pram-Insulin Co-Formulation in Adults With T1D
Baseline characteristics by cohort
| Measure |
PRAM9 to Regular Insulin to Regular Insulin+Pramlintide
n=3 Participants
PRAM9 (Xeris pramlintide + insulin co-formulation): SC injection Regular Insulin (Humulin®): SC injection Regular Insulin (Humulin®) + Pramlintide (Symlin®): Separate SC injections
|
Regular Insulin to Regular Insulin+Pramlintide to PRAM9
n=3 Participants
PRAM9 (Xeris pramlintide + insulin co-formulation): SC injection Regular Insulin (Humulin®): SC injection Regular Insulin (Humulin®) + Pramlintide (Symlin®): Separate SC injections
|
Regular Insulin+Pramlintide to PRAM9 to Regular Insulin
n=3 Participants
PRAM9 (Xeris pramlintide + insulin co-formulation): SC injection Regular Insulin (Humulin®): SC injection Regular Insulin (Humulin®) + Pramlintide (Symlin®): Separate SC injections
|
PRAM9 to Regular Insulin+Pramlintide to Regular Insulin
n=3 Participants
PRAM9 (Xeris pramlintide + insulin co-formulation): SC injection Regular Insulin (Humulin®): SC injection Regular Insulin (Humulin®) + Pramlintide (Symlin®): Separate SC injections
|
Regular Insulin to PRAM9 to Regular Insulin+Pramlintide
n=3 Participants
PRAM9 (Xeris pramlintide + insulin co-formulation): SC injection Regular Insulin (Humulin®): SC injection Regular Insulin (Humulin®) + Pramlintide (Symlin®): Separate SC injections
|
Regular Insulin+Pramlintide to Regular Insulin to PRAM9
n=3 Participants
PRAM9 (Xeris pramlintide + insulin co-formulation): SC injection Regular Insulin (Humulin®): SC injection Regular Insulin (Humulin®) + Pramlintide (Symlin®): Separate SC injections
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
18 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Age, Continuous
|
46.7 years
STANDARD_DEVIATION 21.36 • n=99 Participants
|
45.0 years
STANDARD_DEVIATION 18.68 • n=107 Participants
|
42.3 years
STANDARD_DEVIATION 14.50 • n=206 Participants
|
38.0 years
STANDARD_DEVIATION 5.57 • n=7 Participants
|
42.0 years
STANDARD_DEVIATION 9.54 • n=31 Participants
|
49.3 years
STANDARD_DEVIATION 4.73 • n=30 Participants
|
43.9 years
STANDARD_DEVIATION 12.27 • n=3 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
10 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
8 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
12 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
17 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
3 participants
n=7 Participants
|
3 participants
n=31 Participants
|
3 participants
n=30 Participants
|
18 participants
n=3 Participants
|
|
Weight
|
81.30 kg
STANDARD_DEVIATION 4.952 • n=99 Participants
|
72.23 kg
STANDARD_DEVIATION 2.902 • n=107 Participants
|
83.43 kg
STANDARD_DEVIATION 22.74 • n=206 Participants
|
62.27 kg
STANDARD_DEVIATION 4.099 • n=7 Participants
|
76.20 kg
STANDARD_DEVIATION 11.888 • n=31 Participants
|
80.53 kg
STANDARD_DEVIATION 11.869 • n=30 Participants
|
75.99 kg
STANDARD_DEVIATION 12.407 • n=3 Participants
|
|
Height
|
175.43 cm
STANDARD_DEVIATION 7.643 • n=99 Participants
|
173.20 cm
STANDARD_DEVIATION 15.552 • n=107 Participants
|
170.47 cm
STANDARD_DEVIATION 14.332 • n=206 Participants
|
160.17 cm
STANDARD_DEVIATION 5.299 • n=7 Participants
|
169.17 cm
STANDARD_DEVIATION 17.208 • n=31 Participants
|
175.00 cm
STANDARD_DEVIATION 9.034 • n=30 Participants
|
170.57 cm
STANDARD_DEVIATION 11.642 • n=3 Participants
|
|
Body Mass Index
|
26.543 kg/m^2
STANDARD_DEVIATION 3.060 • n=99 Participants
|
24.340 kg/m^2
STANDARD_DEVIATION 3.196 • n=107 Participants
|
28.267 kg/m^2
STANDARD_DEVIATION 3.248 • n=206 Participants
|
24.313 kg/m^2
STANDARD_DEVIATION 2.039 • n=7 Participants
|
26.620 kg/m^2
STANDARD_DEVIATION 1.257 • n=31 Participants
|
26.183 kg/m^2
STANDARD_DEVIATION 1.669 • n=30 Participants
|
26.044 kg/m^2
STANDARD_DEVIATION 2.562 • n=3 Participants
|
PRIMARY outcome
Timeframe: 0-180 minutes following administration of study drugPopulation: The number of participants analyzed were the number of participants with glucose \>180 mg/dL.
The PD effects on plasma glucose levels were compared among the treatment arms as defined by AUC0-180 (mg/dL \* minutes) for plasma glucose \>180 mg/dL
Outcome measures
| Measure |
PRAM9
n=14 Participants
PRAM9 (Xeris pramlintide + insulin co-formulation): SC injection
|
Regular Insulin + Pramlintide
n=16 Participants
Regular Insulin (Humulin®) + Pramlintide (Symlin®): Separate SC injections
|
Regular Insulin
n=14 Participants
Regular Insulin (Humulin®): SC injection
|
|---|---|---|---|
|
Area Under the Curve 0-180 Minutes for Plasma Glucose >180 mg/dL
|
5019.6 min*mg/dL
Standard Deviation 4276.53
|
4591.9 min*mg/dL
Standard Deviation 3095.53
|
13317.5 min*mg/dL
Standard Deviation 5262.42
|
SECONDARY outcome
Timeframe: Up to 360 minutes following administration of study drugPopulation: The number of participants analyzed were the number of participants 0 to 90, 0 to 180, and 0 to 360 minutes after study drug administration with any evaluable plasma glucose concentration data. (While the number of participants noted for each datapoint had evaluable plasma glucose concentration data, not all of the participants had values in the range of plasma glucose concentration required for the analysis of the proportion of time with glucose concentrations in the specified range.)
The mean proportional times were evaluated for the following Plasma Glucose Levels: \>180 mg/dL, \>250 mg/dL, \<54 mg/dL, and \<70 The mean proportional times evaluated for each Plasma Glucose Level were during the following post-study drug injection periods: 0 to 90 minutes, 0 to 180 minutes, 0 to 360 minutes
Outcome measures
| Measure |
PRAM9
n=18 Participants
PRAM9 (Xeris pramlintide + insulin co-formulation): SC injection
|
Regular Insulin + Pramlintide
n=18 Participants
Regular Insulin (Humulin®) + Pramlintide (Symlin®): Separate SC injections
|
Regular Insulin
n=17 Participants
Regular Insulin (Humulin®): SC injection
|
|---|---|---|---|
|
Mean Proportional Time for Plasma Glucose Levels
>180 mg/dL: 0 to 90 minutes
|
5.6 percentage of time
Standard Deviation 13.61
|
0.0 percentage of time
Standard Deviation 0.00
|
17.6 percentage of time
Standard Deviation 16.72
|
|
Mean Proportional Time for Plasma Glucose Levels
>180 mg/dL: 0 to 180 minutes
|
33.3 percentage of time
Standard Deviation 19.61
|
31.3 percentage of time
Standard Deviation 13.44
|
58.7 percentage of time
Standard Deviation 14.57
|
|
Mean Proportional Time for Plasma Glucose Levels
>180 mg/dL: 0 to 360 minutes
|
45.8 percentage of time
Standard Deviation 24.79
|
45.1 percentage of time
Standard Deviation 23.21
|
50.8 percentage of time
Standard Deviation 18.25
|
|
Mean Proportional Time for Plasma Glucose Levels
>250 mg/dL: 0 to 180 minutes
|
19.7 percentage of time
Standard Deviation 17.98
|
18.0 percentage of time
Standard Deviation 15.90
|
40.3 percentage of time
Standard Deviation 15.01
|
|
Mean Proportional Time for Plasma Glucose Levels
>250 mg/dL: 0 to 360 minutes
|
27.1 percentage of time
Standard Deviation 21.41
|
28.6 percentage of time
Standard Deviation 19.81
|
33.3 percentage of time
Standard Deviation 16.67
|
|
Mean Proportional Time for Plasma Glucose Levels
<54 mg/dL: 0 to 90 minutes
|
14.8 percentage of time
Standard Deviation 16.97
|
19.4 percentage of time
Standard Deviation 24.64
|
0 percentage of time
Standard Deviation 0
|
|
Mean Proportional Time for Plasma Glucose Levels
<54 mg/dL: 0 to 180 minutes
|
7.4 percentage of time
Standard Deviation 8.49
|
9.7 percentage of time
Standard Deviation 12.32
|
0 percentage of time
Standard Deviation 0
|
|
Mean Proportional Time for Plasma Glucose Levels
<54 mg/dL: 0 to 360 minutes
|
3.7 percentage of time
Standard Deviation 4.25
|
43.1 percentage of time
Standard Deviation 49.72
|
52.1 percentage of time
Standard Deviation 40.15
|
|
Mean Proportional Time for Plasma Glucose Levels
<70 mg/dL: 0 to 90 minutes
|
46.7 percentage of time
Standard Deviation 26.53
|
41.3 percentage of time
Standard Deviation 25.43
|
19.4 percentage of time
Standard Deviation 5.56
|
|
Mean Proportional Time for Plasma Glucose Levels
<70 mg/dL: 0 to 180 minutes
|
30.0 percentage of time
Standard Deviation 23.76
|
20.6 percentage of time
Standard Deviation 12.72
|
22.2 percentage of time
Standard Deviation 34.47
|
|
Mean Proportional Time for Plasma Glucose Levels
<70 mg/dL: 0 to 360 minutes
|
15.0 percentage of time
Standard Deviation 11.88
|
28.1 percentage of time
Standard Deviation 39.88
|
52.3 percentage of time
Standard Deviation 42.33
|
SECONDARY outcome
Timeframe: During 40 to 180 minutes post-injection of study drugPopulation: The number of participants analyzed were the number of participants 0 to 90, 0 to 180, and 0 to 360 minutes after study drug administration with any evaluable plasma glucose concentration data. (While the number of participants noted for each data point had evaluable plasma glucose concentration data, not all of the participants had values in the range of plasma glucose concentration required for the analysis of the proportion of time with glucose concentrations in the specified range.)
The mean proportional times to plasma glucose levels between 126 to 180 mg/dL following a glucose challenge administered 30 minutes post study drug administration.
Outcome measures
| Measure |
PRAM9
n=15 Participants
PRAM9 (Xeris pramlintide + insulin co-formulation): SC injection
|
Regular Insulin + Pramlintide
n=12 Participants
Regular Insulin (Humulin®) + Pramlintide (Symlin®): Separate SC injections
|
Regular Insulin
n=16 Participants
Regular Insulin (Humulin®): SC injection
|
|---|---|---|---|
|
Mean Proportional Time After Glucose Challenge for Plasma Glucose Levels Between 126 to 180 mg/dL
|
11.0 percentage of time
Standard Deviation 11.41
|
10.7 percentage of time
Standard Deviation 19.38
|
9.8 percentage of time
Standard Deviation 11.92
|
SECONDARY outcome
Timeframe: Up to 360 minutes following administration of study drugPopulation: The number of participants analyzed were the number of participants after study drug administration with evaluable glucose measurements. (The time period of 0 to 90 minutes after study drug administration with glucose \>250 mg/dL was not quantifiable.)
AUC0-t (mg/dL\*minutes) for plasma glucose X mg/dL, in which X = (\>180 mg/dL, \>250 mg/dL) and t = 90, 180, and 360 minutes
Outcome measures
| Measure |
PRAM9
n=18 Participants
PRAM9 (Xeris pramlintide + insulin co-formulation): SC injection
|
Regular Insulin + Pramlintide
n=18 Participants
Regular Insulin (Humulin®) + Pramlintide (Symlin®): Separate SC injections
|
Regular Insulin
n=17 Participants
Regular Insulin (Humulin®): SC injection
|
|---|---|---|---|
|
Area Under the Concentration (AUC) Curve for Plasma Glucose
AUC 0-90: >180 mg/dL
|
475.0 min*mg/dL
Standard Deviation 1163.51
|
0 min*mg/dL
Standard Deviation 0
|
1108.3 min*mg/dL
Standard Deviation 1193.57
|
|
Area Under the Concentration (AUC) Curve for Plasma Glucose
AUC 0-180: >180 mg/dL
|
5019.6 min*mg/dL
Standard Deviation 4276.53
|
4591.9 min*mg/dL
Standard Deviation 3095.53
|
13317.5 min*mg/dL
Standard Deviation 5262.42
|
|
Area Under the Concentration (AUC) Curve for Plasma Glucose
AUC 0-360: >180 mg/dL
|
16255.8 min*mg/dL
Standard Deviation 13128.46
|
16101.2 min*mg/dL
Standard Deviation 11859.68
|
22334.6 min*mg/dL
Standard Deviation 13794.26
|
|
Area Under the Concentration (AUC) Curve for Plasma Glucose
AUC 0-180: >250 mg/dL
|
1592.7 min*mg/dL
Standard Deviation 1813.87
|
1455.0 min*mg/dL
Standard Deviation 1783.26
|
6302.5 min*mg/dL
Standard Deviation 3495.22
|
|
Area Under the Concentration (AUC) Curve for Plasma Glucose
AUC 0-360: >250 mg/dL
|
6506.3 min*mg/dL
Standard Deviation 8153.00
|
6847.5 min*mg/dL
Standard Deviation 7282.23
|
16572.5 min*mg/dL
Standard Deviation 26676.00
|
SECONDARY outcome
Timeframe: Up to 360 minutes following administration of study drugPopulation: The number of participants analyzed were the number of participants after study drug administration with evaluable glucose measurements. (There was no data available for the analysis of AOC0-90 for plasma glucose \<54 mg/dL.)
AOC0-t (mg/dL\*minutes) for plasma glucose X mg/dL, in which X = \<54 mg/dL and \<70 mg/dL and t = 90, 180, and 360 minutes
Outcome measures
| Measure |
PRAM9
n=18 Participants
PRAM9 (Xeris pramlintide + insulin co-formulation): SC injection
|
Regular Insulin + Pramlintide
n=18 Participants
Regular Insulin (Humulin®) + Pramlintide (Symlin®): Separate SC injections
|
Regular Insulin
n=17 Participants
Regular Insulin (Humulin®): SC injection
|
|---|---|---|---|
|
Area Over the Concentration (AOC) Curve for Plasma Glucose
AUC 0-90: <54 mg/dL
|
658.3 min*mg/dL
Standard Deviation 753.40
|
677.5 min*mg/dL
Standard Deviation 890.36
|
0.0 min*mg/dL
Standard Deviation 0.00
|
|
Area Over the Concentration (AOC) Curve for Plasma Glucose
AOC 0-180: <54 mg/dL
|
658.3 min*mg/dL
Standard Deviation 753.40
|
677.5 min*mg/dL
Standard Deviation 890.36
|
0 min*mg/dL
Standard Deviation 0
|
|
Area Over the Concentration (AOC) Curve for Plasma Glucose
AOC 0-360: <54 mg/dL
|
658.3 min*mg/dL
Standard Deviation 753.40
|
3545.0 min*mg/dL
Standard Deviation 6603.37
|
7531.3 min*mg/dL
Standard Deviation 5681.44
|
|
Area Over the Concentration (AOC) Curve for Plasma Glucose
AOC 0-90: <70 mg/dL
|
2565.0 min*mg/dL
Standard Deviation 1665.80
|
2086.4 min*mg/dL
Standard Deviation 1355.66
|
1010.0 min*mg/dL
Standard Deviation 337.27
|
|
Area Over the Concentration (AOC) Curve for Plasma Glucose
AOC 0-180: <70 mg/dL
|
3243.0 min*mg/dL
Standard Deviation 2611.35
|
2086.4 min*mg/dL
Standard Deviation 1355.66
|
1874.0 min*mg/dL
Standard Deviation 2587.66
|
|
Area Over the Concentration (AOC) Curve for Plasma Glucose
AOC 0-360: <70 mg/dL
|
3243.0 min*mg/dL
Standard Deviation 2611.35
|
3797.5 min*mg/dL
Standard Deviation 6070.52
|
8242.5 min*mg/dL
Standard Deviation 6016.84
|
SECONDARY outcome
Timeframe: Up to 360 minutes following administration of study drugPopulation: The number of participants analyzed were the number of participants after study drug administration with evaluable glucose measurements.
The maximum measured glucose concentrations over the time span.
Outcome measures
| Measure |
PRAM9
n=18 Participants
PRAM9 (Xeris pramlintide + insulin co-formulation): SC injection
|
Regular Insulin + Pramlintide
n=18 Participants
Regular Insulin (Humulin®) + Pramlintide (Symlin®): Separate SC injections
|
Regular Insulin
n=17 Participants
Regular Insulin (Humulin®): SC injection
|
|---|---|---|---|
|
Plasma Glucose Cmax
|
301.4 mg/dL
Standard Deviation 66.72
|
303.3 mg/dL
Standard Deviation 73.37
|
339.9 mg/dL
Standard Deviation 162.73
|
SECONDARY outcome
Timeframe: Up to 360 minutes following administration of study drugPopulation: The number of participants analyzed were the number of participants after study drug administration with evaluable glucose measurements.
The time to maximum measured glucose concentrations.
Outcome measures
| Measure |
PRAM9
n=18 Participants
PRAM9 (Xeris pramlintide + insulin co-formulation): SC injection
|
Regular Insulin + Pramlintide
n=18 Participants
Regular Insulin (Humulin®) + Pramlintide (Symlin®): Separate SC injections
|
Regular Insulin
n=17 Participants
Regular Insulin (Humulin®): SC injection
|
|---|---|---|---|
|
Plasma Glucose Tmax
|
251.7 minutes
Standard Deviation 83.68
|
208.3 minutes
Standard Deviation 47.68
|
150.0 minutes
Standard Deviation 49.75
|
SECONDARY outcome
Timeframe: Up to 360 minutes following administration of study drugPopulation: The number of participants analyzed were the number of participants after study drug administration with evaluable pramlintide measurements.
The maximum measured pramlintide concentrations (arithmetic mean).
Outcome measures
| Measure |
PRAM9
n=18 Participants
PRAM9 (Xeris pramlintide + insulin co-formulation): SC injection
|
Regular Insulin + Pramlintide
n=18 Participants
Regular Insulin (Humulin®) + Pramlintide (Symlin®): Separate SC injections
|
Regular Insulin
Regular Insulin (Humulin®): SC injection
|
|---|---|---|---|
|
Pramlintide Cmax
|
99.22 pg/mL
Standard Deviation 41.403
|
278.37 pg/mL
Standard Deviation 148.512
|
—
|
SECONDARY outcome
Timeframe: Up to 360 minutes following administration of study drugPopulation: The number of participants analyzed were the number of participants after study drug administration with evaluable pramlintide concentrations.
The time to maximum measured pramlintide concentrations.
Outcome measures
| Measure |
PRAM9
n=18 Participants
PRAM9 (Xeris pramlintide + insulin co-formulation): SC injection
|
Regular Insulin + Pramlintide
n=18 Participants
Regular Insulin (Humulin®) + Pramlintide (Symlin®): Separate SC injections
|
Regular Insulin
Regular Insulin (Humulin®): SC injection
|
|---|---|---|---|
|
Pramlintide Tmax
|
40.5 minutes
Interval 21.0 to 150.0
|
10.0 minutes
Interval 10.0 to 24.0
|
—
|
SECONDARY outcome
Timeframe: Up to 360 minutes following administration of study drugPopulation: The number of participants analyzed were the number of participants after study drug administration with evaluable pramlintide concentrations.
The pramlintide area under the concentration time curve after study drug administration (arithmetic mean).
Outcome measures
| Measure |
PRAM9
n=18 Participants
PRAM9 (Xeris pramlintide + insulin co-formulation): SC injection
|
Regular Insulin + Pramlintide
n=18 Participants
Regular Insulin (Humulin®) + Pramlintide (Symlin®): Separate SC injections
|
Regular Insulin
Regular Insulin (Humulin®): SC injection
|
|---|---|---|---|
|
Pramlintide Area Under the Concentration (AUC) Curve
AUC 0-90
|
5752.239 min*pg/mL
Standard Deviation 2964.0340
|
10317.775 min*pg/mL
Standard Deviation 6782.4249
|
—
|
|
Pramlintide Area Under the Concentration (AUC) Curve
AUC 0-180
|
9021.278 min*pg/mL
Standard Deviation 4669.0851
|
11079.075 min*pg/mL
Standard Deviation 7836.2702
|
—
|
|
Pramlintide Area Under the Concentration (AUC) Curve
AUC 0-360
|
9491.208 min*pg/mL
Standard Deviation 4974.9490
|
11132.408 min*pg/mL
Standard Deviation 7948.9301
|
—
|
SECONDARY outcome
Timeframe: Up to 360 minutes following administration of study drugPopulation: The number of participants analyzed were the number of participants after study drug administration with evaluable insulin measurements.
The maximum measured insulin concentrations (arithmetic mean)
Outcome measures
| Measure |
PRAM9
n=18 Participants
PRAM9 (Xeris pramlintide + insulin co-formulation): SC injection
|
Regular Insulin + Pramlintide
n=18 Participants
Regular Insulin (Humulin®) + Pramlintide (Symlin®): Separate SC injections
|
Regular Insulin
n=17 Participants
Regular Insulin (Humulin®): SC injection
|
|---|---|---|---|
|
Insulin Cmax
|
724.97 pg/mL
Standard Deviation 345.106
|
912.09 pg/mL
Standard Deviation 393.686
|
1198.70 pg/mL
Standard Deviation 439.528
|
SECONDARY outcome
Timeframe: Up to 360 minutes following administration of study drugPopulation: The number of participants analyzed were the number of participants after study drug administration with evaluable insulin concentrations.
The time to maximum measured insulin concentrations.
Outcome measures
| Measure |
PRAM9
n=18 Participants
PRAM9 (Xeris pramlintide + insulin co-formulation): SC injection
|
Regular Insulin + Pramlintide
n=18 Participants
Regular Insulin (Humulin®) + Pramlintide (Symlin®): Separate SC injections
|
Regular Insulin
n=17 Participants
Regular Insulin (Humulin®): SC injection
|
|---|---|---|---|
|
Insulin Tmax
|
120.0 minutes
Interval 0.0 to 241.0
|
90.5 minutes
Interval 40.0 to 300.0
|
121.0 minutes
Interval 30.0 to 360.0
|
SECONDARY outcome
Timeframe: Up to 360 minutes following administration of study drugPopulation: The number of participants analyzed were the number of participants after study drug administration with evaluable insulin concentrations.
The insulin area under the concentration time curve after study drug administration.
Outcome measures
| Measure |
PRAM9
n=18 Participants
PRAM9 (Xeris pramlintide + insulin co-formulation): SC injection
|
Regular Insulin + Pramlintide
n=18 Participants
Regular Insulin (Humulin®) + Pramlintide (Symlin®): Separate SC injections
|
Regular Insulin
n=17 Participants
Regular Insulin (Humulin®): SC injection
|
|---|---|---|---|
|
Insulin Area Under the Concentration (AUC) Curve
AUC 0-90
|
4332.201 min*pg/mL
Standard Deviation 27662.1733
|
52936.566 min*pg/mL
Standard Deviation 25400.6054
|
59727.578 min*pg/mL
Standard Deviation 26405.0845
|
|
Insulin Area Under the Concentration (AUC) Curve
AUC 0-180
|
90807.346 min*pg/mL
Standard Deviation 45238.6643
|
114109.946 min*pg/mL
Standard Deviation 49208.9630
|
143606.541 min*pg/mL
Standard Deviation 54329.1923
|
|
Insulin Area Under the Concentration (AUC) Curve
AUC 0-360
|
150580.775 min*pg/mL
Standard Deviation 73403.0839
|
182852.584 min*pg/mL
Standard Deviation 100930.8761
|
269913.163 min*pg/mL
Standard Deviation 100898.6768
|
Adverse Events
PRAM9
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Regular Insulin + Pramlintide
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Regular Insulin
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PRAM9
n=18 participants at risk
PRAM9 (Xeris pramlintide + insulin co-formulation): SC injection
|
Regular Insulin + Pramlintide
n=18 participants at risk
Regular Insulin (Humulin®) + Pramlintide (Symlin®): Separate SC injections
|
Regular Insulin
n=17 participants at risk
Regular Insulin (Humulin®): SC injection
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
11.1%
2/18 • Number of events 2 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
5.6%
1/18 • Number of events 1 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
0.00%
0/17 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
|
General disorders
Asthenia
|
5.6%
1/18 • Number of events 1 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
0.00%
0/18 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
0.00%
0/17 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
|
General disorders
Injection site bruising
|
0.00%
0/18 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
5.6%
1/18 • Number of events 1 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
0.00%
0/17 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
|
General disorders
Injection site discomfort
|
5.6%
1/18 • Number of events 1 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
5.6%
1/18 • Number of events 1 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
0.00%
0/17 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
|
General disorders
Thirst
|
0.00%
0/18 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
0.00%
0/18 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
5.9%
1/17 • Number of events 1 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
|
General disorders
Vessel puncture site thrombosis
|
0.00%
0/18 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
0.00%
0/18 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
5.9%
1/17 • Number of events 1 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/18 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
5.6%
1/18 • Number of events 1 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
0.00%
0/17 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
33.3%
6/18 • Number of events 9 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
44.4%
8/18 • Number of events 13 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
41.2%
7/17 • Number of events 9 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/18 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
0.00%
0/18 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
5.9%
1/17 • Number of events 1 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
|
Nervous system disorders
Dizziness
|
0.00%
0/18 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
5.6%
1/18 • Number of events 1 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
5.9%
1/17 • Number of events 1 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
|
Nervous system disorders
Headache
|
11.1%
2/18 • Number of events 2 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
5.6%
1/18 • Number of events 1 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
5.9%
1/17 • Number of events 1 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
|
Nervous system disorders
Migraine
|
5.6%
1/18 • Number of events 2 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
0.00%
0/18 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
0.00%
0/17 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
|
Nervous system disorders
Presyncope
|
5.6%
1/18 • Number of events 1 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
0.00%
0/18 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
0.00%
0/17 • AEs were collected from time of ICF signature to up to the follow-up visit (7 to 11 days of last dose of study drug).
A TEAE with onset on or after the first dose of study drug, any preexisting AE worsened in severity on or after first dose of study drug. Assignment of a TEAE to a specific treatment group: * treatment received immediately before onset (including Washout Period) * If severity increased in a later period, TEAE at increased severity assigned to the treatment received immediately before the increase TEAEs missing relationship were assumed to be related to study drug for analysis purposes
|
Additional Information
Dawn Harper, VP Clinical Devlopment
Xeris Pharmaceuticals Inc.
Phone: (215) 704-7290
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place