Trial Outcomes & Findings for Protege Extension Trial - Long Term Follow Up Trial for Subjects Who Completed the Protege Study (CP-MGA031-01) (NCT NCT00870818)
NCT ID: NCT00870818
Last Updated: 2023-08-09
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
219 participants
Primary outcome timeframe
Duration of study participation up to 15 months
Results posted on
2023-08-09
Participant Flow
Participant milestones
| Measure |
Open-label Herold Regimen
Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Herold Regimen
Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind 33.3% Herold Regimen
Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Curtailed Herold Regimen
Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Placebo
Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
32
|
73
|
38
|
38
|
38
|
|
Overall Study
Completed 6 Months
|
31
|
22
|
13
|
13
|
11
|
|
Overall Study
Completed 12 Months
|
27
|
2
|
3
|
2
|
2
|
|
Overall Study
Completed 18 Months
|
5
|
0
|
0
|
0
|
0
|
|
Overall Study
Completed 21 Months
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
32
|
73
|
38
|
38
|
38
|
Reasons for withdrawal
| Measure |
Open-label Herold Regimen
Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Herold Regimen
Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind 33.3% Herold Regimen
Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Curtailed Herold Regimen
Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Placebo
Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
2
|
0
|
|
Overall Study
Terminated by sponsor
|
29
|
70
|
36
|
36
|
38
|
|
Overall Study
Other
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Protege Extension Trial - Long Term Follow Up Trial for Subjects Who Completed the Protege Study (CP-MGA031-01)
Baseline characteristics by cohort
| Measure |
Open-label Herold Regimen
n=32 Participants
Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Herold Regimen
n=73 Participants
Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind 33.3% Herold Regimen
n=38 Participants
Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Curtailed Herold Regimen
n=38 Participants
Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Placebo
n=38 Participants
Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Total
n=219 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
14.0 years
n=5 Participants
|
18.0 years
n=7 Participants
|
18.5 years
n=5 Participants
|
16.0 years
n=4 Participants
|
16.5 years
n=21 Participants
|
18.0 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
74 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
145 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
214 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
72 Participants
n=10 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
146 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
19 participants
n=7 Participants
|
11 participants
n=5 Participants
|
11 participants
n=4 Participants
|
8 participants
n=21 Participants
|
65 participants
n=10 Participants
|
|
Region of Enrollment
Czechia
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
4 participants
n=21 Participants
|
27 participants
n=10 Participants
|
|
Region of Enrollment
India
|
5 participants
n=5 Participants
|
26 participants
n=7 Participants
|
12 participants
n=5 Participants
|
13 participants
n=4 Participants
|
15 participants
n=21 Participants
|
71 participants
n=10 Participants
|
|
Region of Enrollment
Romania
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
12 participants
n=10 Participants
|
|
Region of Enrollment
Ukraine
|
0 participants
n=5 Participants
|
6 participants
n=7 Participants
|
4 participants
n=5 Participants
|
3 participants
n=4 Participants
|
2 participants
n=21 Participants
|
15 participants
n=10 Participants
|
|
Region of Enrollment
Israel
|
0 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
2 participants
n=4 Participants
|
4 participants
n=21 Participants
|
14 participants
n=10 Participants
|
|
Region of Enrollment
Spain
|
0 participants
n=5 Participants
|
4 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
9 participants
n=10 Participants
|
|
Region of Enrollment
Estonia
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
4 participants
n=10 Participants
|
|
Region of Enrollment
Latvia
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
|
Region of Enrollment
Poland
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
|
Region of Enrollment
Sweden
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Duration of study participation up to 15 monthsOutcome measures
| Measure |
Open-label Herold Regimen
n=32 Participants
Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Herold Regimen
n=73 Participants
Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind 33.3% Herold Regimen
n=38 Participants
Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Curtailed Herold Regimen
n=38 Participants
Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Placebo
n=38 Participants
Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
|---|---|---|---|---|---|
|
The Number of Participants Who Experience an Adverse Event, Serious Adverse Event or Adverse Event of Special Interest.
|
8 Participants
|
8 Participants
|
3 Participants
|
10 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Month 6Population: Because the study was terminated early with a limited number of subjects and subject visits, the data are only summarized. Too few data are available for meaningful analysis.
Outcome measures
| Measure |
Open-label Herold Regimen
n=29 Participants
Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Herold Regimen
n=20 Participants
Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind 33.3% Herold Regimen
n=10 Participants
Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Curtailed Herold Regimen
n=11 Participants
Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Placebo
n=8 Participants
Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
|---|---|---|---|---|---|
|
Proportion of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%.
|
3 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Month 12Population: Because the study was terminated early with a limited number of subjects and subject visits, the data are only summarized. Too few data are available for meaningful analysis.
Outcome measures
| Measure |
Open-label Herold Regimen
n=26 Participants
Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Herold Regimen
n=2 Participants
Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind 33.3% Herold Regimen
n=2 Participants
Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Curtailed Herold Regimen
n=2 Participants
Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Placebo
n=2 Participants
Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
|---|---|---|---|---|---|
|
Proportion of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%.
|
4 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Month 6Outcome measures
| Measure |
Open-label Herold Regimen
n=30 Participants
Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Herold Regimen
n=13 Participants
Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind 33.3% Herold Regimen
n=13 Participants
Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Curtailed Herold Regimen
n=13 Participants
Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Placebo
n=11 Participants
Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
|---|---|---|---|---|---|
|
Proportion of Subjects With HbA1c <6.5%
|
5 Participants
|
6 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Because the study was terminated early with a limited number of subjects and subject visits, the data are only summarized. Too few data are available for meaningful analysis.
Outcome measures
| Measure |
Open-label Herold Regimen
n=30 Participants
Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Herold Regimen
n=22 Participants
Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind 33.3% Herold Regimen
n=13 Participants
Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Curtailed Herold Regimen
n=13 Participants
Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Placebo
n=11 Participants
Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
|---|---|---|---|---|---|
|
Mean HbA1c at 6 Months
|
8.24 percentage of glycosylated hemoglobin
Standard Deviation 2.063
|
8.25 percentage of glycosylated hemoglobin
Standard Deviation 0.262
|
8.25 percentage of glycosylated hemoglobin
Standard Deviation 2.709
|
7.83 percentage of glycosylated hemoglobin
Standard Deviation 1.489
|
8.10 percentage of glycosylated hemoglobin
Standard Deviation 1.009
|
SECONDARY outcome
Timeframe: Month 12Population: Because the study was terminated early with a limited number of subjects and subject visits, the data are only summarized. Too few data are available for meaningful analysis.
Outcome measures
| Measure |
Open-label Herold Regimen
n=27 Participants
Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Herold Regimen
n=2 Participants
Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind 33.3% Herold Regimen
n=2 Participants
Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Curtailed Herold Regimen
n=2 Participants
Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Placebo
n=2 Participants
Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
|---|---|---|---|---|---|
|
Mean HbA1c at 12 Months
|
7.81 percentage of glycosylated hemoglobin
Standard Deviation 2.155
|
6.30 percentage of glycosylated hemoglobin
Standard Deviation 0.141
|
6.35 percentage of glycosylated hemoglobin
Standard Deviation 0.354
|
6.05 percentage of glycosylated hemoglobin
Standard Deviation 0.778
|
6.95 percentage of glycosylated hemoglobin
Standard Deviation 0.919
|
SECONDARY outcome
Timeframe: Month 6Population: Because the study was terminated early with a limited number of subjects and subject visits, the data are only summarized. Too few data are available for meaningful analysis.
This outcome measure summarizes the mean and standard deviation of the observed value.
Outcome measures
| Measure |
Open-label Herold Regimen
n=30 Participants
Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Herold Regimen
n=22 Participants
Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind 33.3% Herold Regimen
n=13 Participants
Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Curtailed Herold Regimen
n=11 Participants
Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Placebo
n=10 Participants
Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
|---|---|---|---|---|---|
|
C-peptide Area Under the Curve (AUC) at 6 Months
|
0.30 min*nmol/L
Standard Deviation 0.195
|
0.45 min*nmol/L
Standard Deviation 0.360
|
0.25 min*nmol/L
Standard Deviation 0.301
|
0.25 min*nmol/L
Standard Deviation 0.248
|
0.37 min*nmol/L
Standard Deviation 0.399
|
SECONDARY outcome
Timeframe: Month 12Population: Because the study was terminated early with a limited number of subjects and subject visits, the data are only summarized. Too few data are available for meaningful analysis.
This outcome measure summarizes the mean and standard deviation of the observed value.
Outcome measures
| Measure |
Open-label Herold Regimen
n=27 Participants
Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Herold Regimen
n=2 Participants
Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind 33.3% Herold Regimen
n=2 Participants
Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Curtailed Herold Regimen
n=2 Participants
Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Placebo
n=2 Participants
Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
|---|---|---|---|---|---|
|
C-peptide AUC at 12 Months
|
0.32 min*nmol/L
Standard Deviation 0.183
|
0.56 min*nmol/L
Standard Deviation 0.123
|
0.26 min*nmol/L
Standard Deviation 0.276
|
0.59 min*nmol/L
Standard Deviation 0.036
|
0.19 min*nmol/L
Standard Deviation 0.058
|
SECONDARY outcome
Timeframe: Month 6Outcome measures
| Measure |
Open-label Herold Regimen
n=30 Participants
Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Herold Regimen
n=20 Participants
Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind 33.3% Herold Regimen
n=10 Participants
Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Curtailed Herold Regimen
n=11 Participants
Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Placebo
n=8 Participants
Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
|---|---|---|---|---|---|
|
Total Daily Insulin Usage at 6 Months
|
0.71 units/kg/day
Standard Deviation 0.362
|
0.71 units/kg/day
Standard Deviation 0.451
|
0.64 units/kg/day
Standard Deviation 0.274
|
0.81 units/kg/day
Standard Deviation 0.433
|
0.60 units/kg/day
Standard Deviation 0.251
|
SECONDARY outcome
Timeframe: Month 12Outcome measures
| Measure |
Open-label Herold Regimen
n=26 Participants
Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Herold Regimen
n=2 Participants
Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind 33.3% Herold Regimen
n=2 Participants
Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Curtailed Herold Regimen
n=2 Participants
Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Placebo
n=2 Participants
Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
|---|---|---|---|---|---|
|
Total Daily Insulin Usage at 12 Months
|
0.67 units/kg/day
Standard Deviation 0.280
|
0.47 units/kg/day
Standard Deviation 0.073
|
0.49 units/kg/day
Standard Deviation 0.076
|
0.40 units/kg/day
Standard Deviation 0.147
|
0.76 units/kg/day
Standard Deviation 0.272
|
SECONDARY outcome
Timeframe: Month 6Population: Because the study was terminated early with a limited number of subjects and subject visits, the data are only summarized. Too few data are available for meaningful analysis.
The EQ-5D is a self-reported survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 3-level severity ranking that ranges from "no problems", "some problems", and "extreme problems". The lowest possible score is 5 and the highest possible score is 15. Lower scores indicate better quality of life.
Outcome measures
| Measure |
Open-label Herold Regimen
n=27 Participants
Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Herold Regimen
n=18 Participants
Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind 33.3% Herold Regimen
n=10 Participants
Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Curtailed Herold Regimen
n=11 Participants
Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Placebo
n=9 Participants
Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
|---|---|---|---|---|---|
|
Mean Values for Participant-reported Outcomes on the 5-dimension European Quality of Life Questionnaire. (EQ-5D)
|
5.3 units on a scale
Standard Deviation 0.53
|
5.8 units on a scale
Standard Deviation 1.25
|
5.2 units on a scale
Standard Deviation 0.63
|
5.1 units on a scale
Standard Deviation 0.30
|
5.7 units on a scale
Standard Deviation 1.12
|
SECONDARY outcome
Timeframe: Month 12Population: Because the study was terminated early with a limited number of subjects and subject visits, the data are only summarized. Too few data are available for meaningful analysis.
The EQ-5D is a self-reported survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 3-level severity ranking that ranges from "no problems", "some problems", and "extreme problems". The lowest possible score is 5 and the highest possible score is 15. Lower scores indicate better quality of life.
Outcome measures
| Measure |
Open-label Herold Regimen
n=26 Participants
Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Herold Regimen
n=2 Participants
Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind 33.3% Herold Regimen
n=2 Participants
Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Curtailed Herold Regimen
n=2 Participants
Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Placebo
n=2 Participants
Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
|---|---|---|---|---|---|
|
Mean Values for Participant-reported Outcomes on the EQ-5D
|
5.1 units on a scale
Standard Deviation 0.33
|
6.52 units on a scale
Standard Deviation 2.12
|
5.0 units on a scale
Standard Deviation 0.00
|
5.0 units on a scale
Standard Deviation 0.00
|
6.0 units on a scale
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: Month 6Population: Pediatric patients who completed the questionnaire. Because the study was terminated early with a limited number of subjects and subject visits, the data are only summarized. Too few data are available for meaningful analysis.
The 23-item PEDs QL generic core scales were designed to measure the core dimensions of health (physical, emotional, social and school functioning). Answers are scored from 0 meaning never to 4 meaning almost always. Lower scores indicated higher quality of life. Items on the questionnaire were reversely scored and linearly transformed to a 0-100 scale, so that higher scores indicated better patient reported outcome. The mean was computed as the sum of the items over the number of items answered (to account for missing data). If more than 50% of the items in the scale were missing, the score was not computed.
Outcome measures
| Measure |
Open-label Herold Regimen
n=26 Participants
Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Herold Regimen
n=18 Participants
Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind 33.3% Herold Regimen
n=10 Participants
Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Curtailed Herold Regimen
n=10 Participants
Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Placebo
n=10 Participants
Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
|---|---|---|---|---|---|
|
Pediatric Quality of Life Questionnaire Total Score
|
7.7 units on a scale
Standard Deviation 6.82
|
13.5 units on a scale
Standard Deviation 13.07
|
12.2 units on a scale
Standard Deviation 8.82
|
9.3 units on a scale
Standard Deviation 10.52
|
13.8 units on a scale
Standard Deviation 15.66
|
SECONDARY outcome
Timeframe: Month 12Population: Pediatric patients completing PedQL questionnaire. Because the study was terminated early with a limited number of subjects and subject visits, the data are only summarized. Too few data are available for meaningful analysis.
The 23-item PEDs QL generic core scales were designed to measure the core dimensions of health (physical, emotional, social and school functioning). Answers are scored from 0 meaning never to 4 meaning almost always. Lower scores indicated higher quality of life. Items on the questionnaire were reversely scored and linearly transformed to a 0-100 scale, so that higher scores indicated better patient reported outcome. The mean was computed as the sum of the items over the number of items answered (to account for missing data). If more than 50% of the items in the scale were missing, the score was not computed.
Outcome measures
| Measure |
Open-label Herold Regimen
n=27 Participants
Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Herold Regimen
n=2 Participants
Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind 33.3% Herold Regimen
n=2 Participants
Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Curtailed Herold Regimen
n=2 Participants
Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Placebo
n=2 Participants
Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
|---|---|---|---|---|---|
|
Pediatric Quality of Life Questionnaire Total Score
|
6.3 units on a scale
Standard Deviation 6.39
|
21.0 units on a scale
Standard Deviation 26.87
|
6.5 units on a scale
Standard Deviation 2.12
|
11.0 units on a scale
Standard Deviation 9.90
|
30.5 units on a scale
Standard Deviation 7.78
|
SECONDARY outcome
Timeframe: Month 6Outcome measures
| Measure |
Open-label Herold Regimen
n=9 Participants
Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Herold Regimen
n=5 Participants
Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind 33.3% Herold Regimen
n=4 Participants
Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Curtailed Herold Regimen
n=6 Participants
Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Placebo
n=3 Participants
Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
|---|---|---|---|---|---|
|
Percentage of Cells by Immunophenotype
%CD3+/CD16,CD56+
|
6.7 Percent
Standard Deviation 4.39
|
4.4 Percent
Standard Deviation 1.52
|
7.7 Percent
Standard Deviation 2.85
|
4.8 Percent
Standard Deviation 1.63
|
4.2 Percent
Standard Deviation 1.02
|
|
Percentage of Cells by Immunophenotype
%CD25+/FOXp3+ [of CD4+]
|
0.4 Percent
Standard Deviation 1.87
|
5.5 Percent
Standard Deviation 1.35
|
4.8 Percent
Standard Deviation 1.00
|
6.0 Percent
Standard Deviation 1.28
|
4.5 Percent
Standard Deviation 1.46
|
|
Percentage of Cells by Immunophenotype
%CD25+/FOXp3+ [of CD8+]
|
0.2 Percent
Standard Deviation 0.33
|
0.5 Percent
Standard Deviation 0.3
|
0.4 Percent
Standard Deviation 0.10
|
0.7 Percent
Standard Deviation 0.46
|
0.6 Percent
Standard Deviation 0.35
|
|
Percentage of Cells by Immunophenotype
%CD3-/CD16,CD56+
|
8.9 Percent
Standard Deviation 3.32
|
9.1 Percent
Standard Deviation 3.23
|
6.4 Percent
Standard Deviation 3.09
|
10.7 Percent
Standard Deviation 4.31
|
5.8 Percent
Standard Deviation 2.11
|
|
Percentage of Cells by Immunophenotype
%CD40+ [of CD4+]
|
0.7 Percent
Standard Deviation 0.49
|
1.1 Percent
Standard Deviation 0.48
|
0.9 Percent
Standard Deviation 0.89
|
0.8 Percent
Standard Deviation 0.54
|
0.8 Percent
Standard Deviation 0.52
|
|
Percentage of Cells by Immunophenotype
%CD69+ [of CD4+]
|
0.9 Percent
Standard Deviation 0.77
|
0.1 Percent
Standard Deviation 0.09
|
0.7 Percent
Standard Deviation 1.20
|
0.1 Percent
Standard Deviation 0.12
|
0.1 Percent
Standard Deviation 0.10
|
|
Percentage of Cells by Immunophenotype
%CD69+ [of CD8+]
|
3.7 Percent
Standard Deviation 1.71
|
3.3 Percent
Standard Deviation 0.23
|
3.4 Percent
Standard Deviation 1.39
|
3.4 Percent
Standard Deviation 1.25
|
4.2 Percent
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: Month 6 and 12Patients with HAHA levels \> 0.
Outcome measures
| Measure |
Open-label Herold Regimen
n=32 Participants
Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Herold Regimen
n=73 Participants
Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind 33.3% Herold Regimen
n=38 Participants
Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Curtailed Herold Regimen
n=38 Participants
Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Placebo
n=38 Participants
Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
|---|---|---|---|---|---|
|
Human Anti-human Antibody (HAHA) Levels
Month 6
|
30 Participants
|
22 Participants
|
13 Participants
|
12 Participants
|
11 Participants
|
|
Human Anti-human Antibody (HAHA) Levels
Month 12
|
26 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
Adverse Events
Open-label Herold Regimen
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Double-blind Herold Regimen
Serious events: 5 serious events
Other events: 2 other events
Deaths: 1 deaths
Double-blind 33.3% Herold Regimen
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
Double-blind Curtailed Herold Regimen
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Double-blind Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Open-label Herold Regimen
n=32 participants at risk
Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Herold Regimen
n=73 participants at risk
Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind 33.3% Herold Regimen
n=38 participants at risk
Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Curtailed Herold Regimen
n=38 participants at risk
Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Placebo
n=38 participants at risk
Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
3.1%
1/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
1.4%
1/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
2.6%
1/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
2.6%
1/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
1.4%
1/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Metabolism and nutrition disorders
Hypoglycaemic seizure
|
0.00%
0/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
2.6%
1/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
2.6%
1/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
1.4%
1/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Infections and infestations
Varicella
|
0.00%
0/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
2.6%
1/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
2.6%
1/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
2.6%
1/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Injury, poisoning and procedural complications
Caustic injury
|
0.00%
0/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
1.4%
1/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
2.6%
1/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
2.6%
1/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
2.6%
1/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Eye disorders
Iritis
|
0.00%
0/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
2.6%
1/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
General disorders
Death
|
0.00%
0/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
1.4%
1/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
1.4%
1/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
Other adverse events
| Measure |
Open-label Herold Regimen
n=32 participants at risk
Patients who had been assigned to Herold Regimen in Segment 1 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Herold Regimen
n=73 participants at risk
Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind 33.3% Herold Regimen
n=38 participants at risk
Patients who had been assigned to 33.3% Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Curtailed Herold Regimen
n=38 participants at risk
Patients who had been assigned to Curtailed Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
Double-blind Placebo
n=38 participants at risk
Patients who had been assigned to Placebo in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data.
Blood samples for safety: serum chemistry, hematology, infection screen, thyroid function, Insulin, hemoglobin A1c,and autoantibodies
Patient reported outcome questionnaires: EQ-5D, Peds QL, Low blood sugar survey, and hospitalization information.
Analysis of T-cell subsets: CD3, CD4, CD8, CD19, CD3+ CD16+ CD56+ subsets; CD3-CD16+ CD56+ subsets; CD4+CD25+, CD8+CD25+, CD4+CD69+, CD8+CD69+, CD4+CD40+ subsets CD4+ and CD8+CD25+FoxP3+Treg Subsets
|
|---|---|---|---|---|---|
|
Infections and infestations
Fungal skin infection
|
3.1%
1/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Infections and infestations
Gastrointestinal infection
|
3.1%
1/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Infections and infestations
Herpes zoster
|
3.1%
1/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Infections and infestations
Sinusitis
|
3.1%
1/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
5.3%
2/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.1%
1/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
2.6%
1/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
3.1%
1/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
3.1%
1/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Investigations
Epstein-Barr virus antibody positive
|
3.1%
1/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
2.6%
1/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
1.4%
1/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
2.6%
1/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
2.6%
1/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
1.4%
1/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
2.6%
1/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
2.6%
1/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
2.6%
1/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
2.6%
1/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
2.6%
1/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
2.6%
1/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
5.3%
2/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Nervous system disorders
Diabetic encephalopathy
|
0.00%
0/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
2.6%
1/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
2.6%
1/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
2.6%
1/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
2.6%
1/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
2.6%
1/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
2.6%
1/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
2.6%
1/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/32 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/73 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
0.00%
0/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
2.6%
1/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
2.6%
1/38 • Throughout the study, up to 15 months
Only serious adverse events and adverse events of special interest (AESI) were collected and reported in this study. AESI include non-serious infections, lymphomas or other cancers, new onset autoimmune diseases, events related to complication of diabetes, and clinically significant low blood sugar episodes requiring assistance from another individual.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place