Trial Outcomes & Findings for T1DM Immunotherapy Using CD4+CD127lo/-CD25+ Polyclonal Tregs (NCT NCT01210664)
NCT ID: NCT01210664
Last Updated: 2018-07-11
Results Overview
The number of AEs are reported by cohort and severity.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Mean follow-up of 31 months
Results posted on
2018-07-11
Participant Flow
Participant milestones
| Measure |
Polyclonal Regulatory T Cells, 0.05 x10^8 Cells
Cohort 1: Patients with Type 1 Diabetes Mellitus will have their regulatory T cells (Tregs) isolated by researchers and receive 0.05 x10\^8 cells of Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells by infusion
|
Polyclonal Regulatory T Cells, 0.4 x10^8 Cells
Cohort 2: Patients with Type 1 Diabetes Mellitus will have their regulatory T cells (Tregs) isolated by researchers and receive 0.4 x10\^8 cells of Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells by infusion
|
Polyclonal Regulatory T Cells, 3.2 x10^8 Cells
Cohort 3: Patients with Type 1 Diabetes Mellitus will have their regulatory T cells (Tregs) isolated by researchers and receive 3.2 x10\^8 cells of Ex vivo expanded Human Autologous Polyclonal Regulatory T Cells by infusion
|
Polyclonal Regulatory T Cells, 26 x10^8 Cells
Cohort 4: Patients with Type 1 Diabetes Mellitus will have their regulatory T cells (Tregs) isolated by researchers and receive 26 x10\^8 cells of Ex vivo expanded Human Autologous Polyclonal Regulatory T Cells by infusion
|
|---|---|---|---|---|
|
Cohort 1: PolyTregs 0.05 x 10^8 Cells
STARTED
|
3
|
0
|
0
|
0
|
|
Cohort 1: PolyTregs 0.05 x 10^8 Cells
Received Study Treatment
|
3
|
0
|
0
|
0
|
|
Cohort 1: PolyTregs 0.05 x 10^8 Cells
COMPLETED
|
3
|
0
|
0
|
0
|
|
Cohort 1: PolyTregs 0.05 x 10^8 Cells
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Cohort 2: PolyTregs 0.4 x 10^8 Cells
STARTED
|
0
|
3
|
0
|
0
|
|
Cohort 2: PolyTregs 0.4 x 10^8 Cells
Received Study Treatment
|
0
|
3
|
0
|
0
|
|
Cohort 2: PolyTregs 0.4 x 10^8 Cells
COMPLETED
|
0
|
3
|
0
|
0
|
|
Cohort 2: PolyTregs 0.4 x 10^8 Cells
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Cohort 3: PolyTregs 3.2 x 10^8 Cells
STARTED
|
0
|
0
|
5
|
0
|
|
Cohort 3: PolyTregs 3.2 x 10^8 Cells
Received Study Treatment
|
0
|
0
|
4
|
0
|
|
Cohort 3: PolyTregs 3.2 x 10^8 Cells
COMPLETED
|
0
|
0
|
3
|
0
|
|
Cohort 3: PolyTregs 3.2 x 10^8 Cells
NOT COMPLETED
|
0
|
0
|
2
|
0
|
|
Cohort 4: PolyTregs 26 x 10^8 Cells
STARTED
|
0
|
0
|
0
|
5
|
|
Cohort 4: PolyTregs 26 x 10^8 Cells
Received Study Treatment
|
0
|
0
|
0
|
4
|
|
Cohort 4: PolyTregs 26 x 10^8 Cells
COMPLETED
|
0
|
0
|
0
|
4
|
|
Cohort 4: PolyTregs 26 x 10^8 Cells
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Polyclonal Regulatory T Cells, 0.05 x10^8 Cells
Cohort 1: Patients with Type 1 Diabetes Mellitus will have their regulatory T cells (Tregs) isolated by researchers and receive 0.05 x10\^8 cells of Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells by infusion
|
Polyclonal Regulatory T Cells, 0.4 x10^8 Cells
Cohort 2: Patients with Type 1 Diabetes Mellitus will have their regulatory T cells (Tregs) isolated by researchers and receive 0.4 x10\^8 cells of Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells by infusion
|
Polyclonal Regulatory T Cells, 3.2 x10^8 Cells
Cohort 3: Patients with Type 1 Diabetes Mellitus will have their regulatory T cells (Tregs) isolated by researchers and receive 3.2 x10\^8 cells of Ex vivo expanded Human Autologous Polyclonal Regulatory T Cells by infusion
|
Polyclonal Regulatory T Cells, 26 x10^8 Cells
Cohort 4: Patients with Type 1 Diabetes Mellitus will have their regulatory T cells (Tregs) isolated by researchers and receive 26 x10\^8 cells of Ex vivo expanded Human Autologous Polyclonal Regulatory T Cells by infusion
|
|---|---|---|---|---|
|
Cohort 3: PolyTregs 3.2 x 10^8 Cells
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Cohort 3: PolyTregs 3.2 x 10^8 Cells
Treg Manufacturing Failure
|
0
|
0
|
1
|
0
|
|
Cohort 4: PolyTregs 26 x 10^8 Cells
Treg Manufacturing Failure
|
0
|
0
|
0
|
1
|
Baseline Characteristics
T1DM Immunotherapy Using CD4+CD127lo/-CD25+ Polyclonal Tregs
Baseline characteristics by cohort
| Measure |
Polyclonal Regulatory T Cells
n=14 Participants
Patients with Type 1 Diabetes Mellitus will have their regulatory T cells (Tregs) isolated by researchers and receive Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells by infusion
Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells: The researchers will multiply/expand the Tregs in the laboratory using anti-CD3/anti-CD28 coated beads plus IL-2. Then, the Tregs will be infused back into the patient in a single infusion. The first cohort will receive 0.05 x10\^8 cells. The second cohort will receive 0.4 x10\^8 cells. The third cohort will receive 3.2 x10\^8 cells. The fourth cohort will receive 26 x10\^8 cells.
|
|---|---|
|
Age, Continuous
|
30.3 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Mean follow-up of 31 monthsPopulation: Safety analysis includes 14 treated participants who received one dose of PolyTregs at Day 0, two participants who underwent blood draw but did not receive PolyTregs were also included in the safety analysis.
The number of AEs are reported by cohort and severity.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
Target dose of 0.05 X10\^8 cells
|
Cohort 2
n=3 Participants
Target dose of 0.4 X10\^8 cells
|
Cohort 3
n=5 Participants
Target dose 3.2 x10\^8 cells
|
Cohort 4
n=5 Participants
Target dose 26 x10\^8 cells
|
|---|---|---|---|---|
|
Adverse Events (AEs) as a Measure of Safety and Tolerability
Grade 1 Mild
|
25 adverse events
|
19 adverse events
|
31 adverse events
|
29 adverse events
|
|
Adverse Events (AEs) as a Measure of Safety and Tolerability
Grade 2 Moderate
|
5 adverse events
|
9 adverse events
|
28 adverse events
|
7 adverse events
|
|
Adverse Events (AEs) as a Measure of Safety and Tolerability
Grade 3 Severe
|
0 adverse events
|
2 adverse events
|
6 adverse events
|
3 adverse events
|
|
Adverse Events (AEs) as a Measure of Safety and Tolerability
Grade 4 Life Threatening
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
PRIMARY outcome
Timeframe: Mean follow-up of 31 monthsPopulation: Safety analysis includes 14 treated participants who received one dose of PolyTregs at Day 0, two participants who underwent blood draw but did not receive PolyTregs were also included in the safety analysis.
Laboratory measures tested include: hematology, blood chemistry, endocrine values, autoantibodies, and ophthalmologic exam results Total number of participants experiencing severe or life-threatening laboratory abnormalities is reported for each cohort. Events reported include hyperglycemia and hypoglycemia.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
Target dose of 0.05 X10\^8 cells
|
Cohort 2
n=3 Participants
Target dose of 0.4 X10\^8 cells
|
Cohort 3
n=5 Participants
Target dose 3.2 x10\^8 cells
|
Cohort 4
n=5 Participants
Target dose 26 x10\^8 cells
|
|---|---|---|---|---|
|
Number of Participants Experiencing Severe or Life Threatening Laboratory Abnormalities
Any severe or life threatening abnormality
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Experiencing Severe or Life Threatening Laboratory Abnormalities
Abnormality related to study drug
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 26 and 52 weeks from baselinePopulation: Population includes 14 participants treated.
Secondary diabetes-related outcome measure: C-peptide response during mixed meal tolerance test at 26 and 52 weeks, reported as the change from baseline in the area under the curve.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
Target dose of 0.05 X10\^8 cells
|
Cohort 2
n=3 Participants
Target dose of 0.4 X10\^8 cells
|
Cohort 3
n=4 Participants
Target dose 3.2 x10\^8 cells
|
Cohort 4
n=4 Participants
Target dose 26 x10\^8 cells
|
|---|---|---|---|---|
|
Percent Change From Baseline in C-peptide Area Under the Curve
26 Weeks
|
24.1 percentage change from baseline
Standard Deviation 26.6
|
17.4 percentage change from baseline
Standard Deviation 19.4
|
14.9 percentage change from baseline
Standard Deviation 12.2
|
-32.9 percentage change from baseline
Standard Deviation 42.9
|
|
Percent Change From Baseline in C-peptide Area Under the Curve
52 Weeks
|
25.5 percentage change from baseline
Standard Deviation 39.4
|
9.2 percentage change from baseline
Standard Deviation 10.2
|
-33.9 percentage change from baseline
Standard Deviation 6.9
|
-48.5 percentage change from baseline
Standard Deviation 42.6
|
SECONDARY outcome
Timeframe: up to 104 weeksPopulation: Population includes 14 participants treated.
Secondary diabetes-related outcome measure will include insulin use
Outcome measures
| Measure |
Cohort 1
n=3 Participants
Target dose of 0.05 X10\^8 cells
|
Cohort 2
n=3 Participants
Target dose of 0.4 X10\^8 cells
|
Cohort 3
n=4 Participants
Target dose 3.2 x10\^8 cells
|
Cohort 4
n=4 Participants
Target dose 26 x10\^8 cells
|
|---|---|---|---|---|
|
Insulin Use
Insulin use at Baseline
|
0.127 U/day/kg
Standard Deviation 0.027
|
0.236 U/day/kg
Standard Deviation 0.016
|
0.346 U/day/kg
Standard Deviation 0.211
|
0.298 U/day/kg
Standard Deviation 0.151
|
|
Insulin Use
Insulin use at Week 26
|
0.193 U/day/kg
Standard Deviation 0.063
|
0.167 U/day/kg
Standard Deviation 0.047
|
0.397 U/day/kg
Standard Deviation 0.080
|
0.294 U/day/kg
Standard Deviation 0.137
|
|
Insulin Use
Insulin use at Week 52
|
0.245 U/day/kg
Standard Deviation 0.069
|
0.219 U/day/kg
Standard Deviation 0.066
|
0.444 U/day/kg
Standard Deviation 0.108
|
0.385 U/day/kg
Standard Deviation 0.168
|
|
Insulin Use
Insulin use at Week 104
|
0.334 U/day/kg
Standard Deviation 0.064
|
0.222 U/day/kg
Standard Deviation 0.049
|
0.484 U/day/kg
Standard Deviation 0.050
|
0.550 U/day/kg
Standard Deviation 0.346
|
SECONDARY outcome
Timeframe: Up to 104 weeksPopulation: Population includes 14 participants treated
Secondary diabetes-related outcome measure will include hemoglobin A1c
Outcome measures
| Measure |
Cohort 1
n=3 Participants
Target dose of 0.05 X10\^8 cells
|
Cohort 2
n=3 Participants
Target dose of 0.4 X10\^8 cells
|
Cohort 3
n=4 Participants
Target dose 3.2 x10\^8 cells
|
Cohort 4
n=4 Participants
Target dose 26 x10\^8 cells
|
|---|---|---|---|---|
|
Hemoglobin A1c
HbA1c at Baseline
|
5.5 % of HbA1c
Standard Deviation 0.8
|
5.6 % of HbA1c
Standard Deviation 0.4
|
6.5 % of HbA1c
Standard Deviation 0.8
|
6.7 % of HbA1c
Standard Deviation 2.2
|
|
Hemoglobin A1c
HbAlc at 26 Weeks
|
5.5 % of HbA1c
Standard Deviation 0.8
|
5.8 % of HbA1c
Standard Deviation 0.4
|
6.5 % of HbA1c
Standard Deviation 0.9
|
7.2 % of HbA1c
Standard Deviation 2.0
|
|
Hemoglobin A1c
HbA1c at 52 Weeks
|
6.1 % of HbA1c
Standard Deviation 0.9
|
5.8 % of HbA1c
Standard Deviation 0.6
|
6.7 % of HbA1c
Standard Deviation 1.0
|
7.6 % of HbA1c
Standard Deviation 1.8
|
|
Hemoglobin A1c
HbA1c at 104 Weeks
|
5.7 % of HbA1c
Standard Deviation 0.8
|
6.1 % of HbA1c
Standard Deviation 0.6
|
6.8 % of HbA1c
Standard Deviation 1.0
|
8.2 % of HbA1c
Standard Deviation 2.3
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 3
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 4
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=3 participants at risk
Target dose of 0.05 X10\^8 cells
|
Cohort 2
n=3 participants at risk
Target dose of 0.4 X10\^8 cells
|
Cohort 3
n=5 participants at risk
Target dose 3.2 x10\^8 cells
|
Cohort 4
n=5 participants at risk
Target dose 26 x10\^8 cells
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
20.0%
1/5 • Number of events 3 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
Other adverse events
| Measure |
Cohort 1
n=3 participants at risk
Target dose of 0.05 X10\^8 cells
|
Cohort 2
n=3 participants at risk
Target dose of 0.4 X10\^8 cells
|
Cohort 3
n=5 participants at risk
Target dose 3.2 x10\^8 cells
|
Cohort 4
n=5 participants at risk
Target dose 26 x10\^8 cells
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3 • up to 5 years
|
33.3%
1/3 • Number of events 1 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
General disorders
Fatigue
|
0.00%
0/3 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
|
Investigations
Cholesterol high
|
33.3%
1/3 • Number of events 2 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
Immune system disorders
Allergic Reaction
|
0.00%
0/3 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
Vascular disorders
Hematoma
|
0.00%
0/3 • up to 5 years
|
33.3%
1/3 • Number of events 1 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
Endocrine disorders
Hypoglycemia
|
0.00%
0/3 • up to 5 years
|
33.3%
1/3 • Number of events 1 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
20.0%
1/5 • Number of events 2 • up to 5 years
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
Endocrine disorders
Polydipsia
|
0.00%
0/3 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
|
Eye disorders
Right Eye Pain
|
0.00%
0/3 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 1 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
20.0%
1/5 • Number of events 3 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
20.0%
1/5 • Number of events 4 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • up to 5 years
|
33.3%
1/3 • Number of events 1 • up to 5 years
|
40.0%
2/5 • Number of events 4 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
|
Gastrointestinal disorders
Geographic tongue
|
33.3%
1/3 • Number of events 1 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
Gastrointestinal disorders
Gastrointestinal virus
|
0.00%
0/3 • up to 5 years
|
33.3%
1/3 • Number of events 1 • up to 5 years
|
40.0%
2/5 • Number of events 2 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/3 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
|
Gastrointestinal disorders
Oral ulcers
|
0.00%
0/3 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
|
General disorders
Chills
|
0.00%
0/3 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
|
General disorders
Edema limbs
|
0.00%
0/3 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
|
General disorders
Fever
|
0.00%
0/3 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
20.0%
1/5 • Number of events 2 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
|
General disorders
Flu like symptoms
|
66.7%
2/3 • Number of events 4 • up to 5 years
|
66.7%
2/3 • Number of events 2 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
20.0%
1/5 • Number of events 2 • up to 5 years
|
|
General disorders
Pain
|
0.00%
0/3 • up to 5 years
|
66.7%
2/3 • Number of events 4 • up to 5 years
|
40.0%
2/5 • Number of events 3 • up to 5 years
|
40.0%
2/5 • Number of events 2 • up to 5 years
|
|
Infections and infestations
Eye infection
|
0.00%
0/3 • up to 5 years
|
33.3%
1/3 • Number of events 1 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
Infections and infestations
Pharyngitis
|
33.3%
1/3 • Number of events 1 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
|
Infections and infestations
Sinusitis
|
33.3%
1/3 • Number of events 1 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
Infections and infestations
Skin infection
|
33.3%
1/3 • Number of events 2 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
20.0%
1/5 • Number of events 3 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/3 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • up to 5 years
|
33.3%
1/3 • Number of events 1 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
Infections and infestations
Gastrointestinal infection
|
33.3%
1/3 • Number of events 1 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
Infections and infestations
Gluteal abscess
|
33.3%
1/3 • Number of events 1 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
Infections and infestations
Warts
|
0.00%
0/3 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
|
Infections and infestations
Upper respiratory infection
|
100.0%
3/3 • Number of events 6 • up to 5 years
|
66.7%
2/3 • Number of events 5 • up to 5 years
|
80.0%
4/5 • Number of events 9 • up to 5 years
|
80.0%
4/5 • Number of events 5 • up to 5 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/3 • up to 5 years
|
33.3%
1/3 • Number of events 1 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
Investigations
Elevated D-dimer
|
0.00%
0/3 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
33.3%
1/3 • Number of events 1 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 1 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
20.0%
1/5 • Number of events 2 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/3 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/3 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Sprain
|
0.00%
0/3 • up to 5 years
|
33.3%
1/3 • Number of events 1 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Tendinitis
|
0.00%
0/3 • up to 5 years
|
33.3%
1/3 • Number of events 2 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Torn Muscle
|
0.00%
0/3 • up to 5 years
|
33.3%
1/3 • Number of events 1 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/3 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Epicondylitis
|
0.00%
0/3 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/3 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
|
Nervous system disorders
Dysesthesia
|
0.00%
0/3 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • up to 5 years
|
66.7%
2/3 • Number of events 3 • up to 5 years
|
20.0%
1/5 • Number of events 4 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
|
Nervous system disorders
Peripheral sensory nueropathy
|
0.00%
0/3 • up to 5 years
|
33.3%
1/3 • Number of events 1 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
40.0%
2/5 • Number of events 2 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
Psychiatric disorders
Anxiety
|
66.7%
2/3 • Number of events 2 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
33.3%
1/3 • Number of events 1 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
66.7%
2/3 • Number of events 2 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
40.0%
2/5 • Number of events 2 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
40.0%
2/5 • Number of events 2 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
Skin and subcutaneous tissue disorders
Lipohypertrophy
|
0.00%
0/3 • up to 5 years
|
33.3%
1/3 • Number of events 1 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
1/3 • Number of events 1 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
40.0%
2/5 • Number of events 3 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
|
Skin and subcutaneous tissue disorders
Erythema
|
33.3%
1/3 • Number of events 1 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
20.0%
1/5 • Number of events 2 • up to 5 years
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/3 • up to 5 years
|
33.3%
1/3 • Number of events 1 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/3 • up to 5 years
|
33.3%
1/3 • Number of events 1 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • up to 5 years
|
0.00%
0/3 • up to 5 years
|
20.0%
1/5 • Number of events 1 • up to 5 years
|
0.00%
0/5 • up to 5 years
|
Additional Information
Jeffrey Bluestone, PhD
University of California San Francisco Diabetes Center
Phone: 415-502-5677
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place