Trial Outcomes & Findings for STOP-T1D Low-Dose (ATG) (NCT NCT04291703)
NCT ID: NCT04291703
Last Updated: 2026-05-07
Results Overview
The primary outcome is the elapsed time between random treatment assignment and the development of Stage 3 diabetes
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
From randomization to study termination, approximately 13 months for the first participant enrolled
Results posted on
2026-05-07
Participant Flow
Participant milestones
| Measure |
Antithymocyte Globulin (ATG)
Participants assigned to this arm will receive ATG
|
Placebo
Participants assigned to this arm will receive saline (placebo)
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
STOP-T1D Low-Dose (ATG)
Baseline characteristics by cohort
| Measure |
Antithymocyte Globulin (ATG)
n=1 Participants
Participants assigned to this arm will receive ATG
|
Placebo
n=1 Participants
Participants assigned to this arm will receive saline (placebo)
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: From randomization to study termination, approximately 13 months for the first participant enrolledThe primary outcome is the elapsed time between random treatment assignment and the development of Stage 3 diabetes
Outcome measures
| Measure |
Antithymocyte Globulin (ATG)
n=1 Participants
Participants assigned to this arm will receive ATG.
|
Placebo
n=1 Participants
Participants assigned to this arm will receive saline (placebo)
|
|---|---|---|
|
Progression to Stage 3 T1D
|
16 Days between randomization and diagnosis
|
87 Days between randomization and diagnosis
|
Adverse Events
Antithymocyte Globulin (ATG)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Antithymocyte Globulin (ATG)
n=1 participants at risk
Participants assigned to this arm will receive ATG
|
Placebo
n=1 participants at risk
Participants assigned to this arm will receive saline (placebo)
|
|---|---|---|
|
Nervous system disorders
Headache
|
100.0%
1/1 • Enrollment through study termination, approximately 13 months after the first participant was enrolled
In this clinical trial, an adverse event is any occurrence or worsening of an undesirable or unintended sign, symptom or disease whether or not associated with the treatment and study procedures. The National Cancer Institute (NCI) Common Technology Criteria for Adverse Events (CTCAE) was used for classification of the severity of adverse events with the exception of severe hypoglycemia and hyperglycemia.
|
100.0%
1/1 • Enrollment through study termination, approximately 13 months after the first participant was enrolled
In this clinical trial, an adverse event is any occurrence or worsening of an undesirable or unintended sign, symptom or disease whether or not associated with the treatment and study procedures. The National Cancer Institute (NCI) Common Technology Criteria for Adverse Events (CTCAE) was used for classification of the severity of adverse events with the exception of severe hypoglycemia and hyperglycemia.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/1 • Enrollment through study termination, approximately 13 months after the first participant was enrolled
In this clinical trial, an adverse event is any occurrence or worsening of an undesirable or unintended sign, symptom or disease whether or not associated with the treatment and study procedures. The National Cancer Institute (NCI) Common Technology Criteria for Adverse Events (CTCAE) was used for classification of the severity of adverse events with the exception of severe hypoglycemia and hyperglycemia.
|
100.0%
1/1 • Enrollment through study termination, approximately 13 months after the first participant was enrolled
In this clinical trial, an adverse event is any occurrence or worsening of an undesirable or unintended sign, symptom or disease whether or not associated with the treatment and study procedures. The National Cancer Institute (NCI) Common Technology Criteria for Adverse Events (CTCAE) was used for classification of the severity of adverse events with the exception of severe hypoglycemia and hyperglycemia.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/1 • Enrollment through study termination, approximately 13 months after the first participant was enrolled
In this clinical trial, an adverse event is any occurrence or worsening of an undesirable or unintended sign, symptom or disease whether or not associated with the treatment and study procedures. The National Cancer Institute (NCI) Common Technology Criteria for Adverse Events (CTCAE) was used for classification of the severity of adverse events with the exception of severe hypoglycemia and hyperglycemia.
|
100.0%
1/1 • Enrollment through study termination, approximately 13 months after the first participant was enrolled
In this clinical trial, an adverse event is any occurrence or worsening of an undesirable or unintended sign, symptom or disease whether or not associated with the treatment and study procedures. The National Cancer Institute (NCI) Common Technology Criteria for Adverse Events (CTCAE) was used for classification of the severity of adverse events with the exception of severe hypoglycemia and hyperglycemia.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
1/1 • Enrollment through study termination, approximately 13 months after the first participant was enrolled
In this clinical trial, an adverse event is any occurrence or worsening of an undesirable or unintended sign, symptom or disease whether or not associated with the treatment and study procedures. The National Cancer Institute (NCI) Common Technology Criteria for Adverse Events (CTCAE) was used for classification of the severity of adverse events with the exception of severe hypoglycemia and hyperglycemia.
|
0.00%
0/1 • Enrollment through study termination, approximately 13 months after the first participant was enrolled
In this clinical trial, an adverse event is any occurrence or worsening of an undesirable or unintended sign, symptom or disease whether or not associated with the treatment and study procedures. The National Cancer Institute (NCI) Common Technology Criteria for Adverse Events (CTCAE) was used for classification of the severity of adverse events with the exception of severe hypoglycemia and hyperglycemia.
|
|
Immune system disorders
Serum sickness
|
100.0%
1/1 • Enrollment through study termination, approximately 13 months after the first participant was enrolled
In this clinical trial, an adverse event is any occurrence or worsening of an undesirable or unintended sign, symptom or disease whether or not associated with the treatment and study procedures. The National Cancer Institute (NCI) Common Technology Criteria for Adverse Events (CTCAE) was used for classification of the severity of adverse events with the exception of severe hypoglycemia and hyperglycemia.
|
0.00%
0/1 • Enrollment through study termination, approximately 13 months after the first participant was enrolled
In this clinical trial, an adverse event is any occurrence or worsening of an undesirable or unintended sign, symptom or disease whether or not associated with the treatment and study procedures. The National Cancer Institute (NCI) Common Technology Criteria for Adverse Events (CTCAE) was used for classification of the severity of adverse events with the exception of severe hypoglycemia and hyperglycemia.
|
|
General disorders
Fatigue
|
100.0%
1/1 • Enrollment through study termination, approximately 13 months after the first participant was enrolled
In this clinical trial, an adverse event is any occurrence or worsening of an undesirable or unintended sign, symptom or disease whether or not associated with the treatment and study procedures. The National Cancer Institute (NCI) Common Technology Criteria for Adverse Events (CTCAE) was used for classification of the severity of adverse events with the exception of severe hypoglycemia and hyperglycemia.
|
0.00%
0/1 • Enrollment through study termination, approximately 13 months after the first participant was enrolled
In this clinical trial, an adverse event is any occurrence or worsening of an undesirable or unintended sign, symptom or disease whether or not associated with the treatment and study procedures. The National Cancer Institute (NCI) Common Technology Criteria for Adverse Events (CTCAE) was used for classification of the severity of adverse events with the exception of severe hypoglycemia and hyperglycemia.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place