Trial Outcomes & Findings for Effects of Recombinant Human Glutamic Acid Decarboxylase on the Progression of Type 1 Diabetes in New Onset Subjects (NCT NCT00529399)
NCT ID: NCT00529399
Last Updated: 2020-05-07
Results Overview
The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
145 participants
Primary outcome timeframe
Based on mixed meal tolerance test (MMTT) conducted at the one year visit
Results posted on
2020-05-07
Participant Flow
The original recruitment goal was to enroll 126 subjects. However, additional eligible subjects were identified during the screening process and 145 subjects were enrolled in the study.
Participant milestones
| Measure |
GAD-alum
3 injections of Glutamic Acid Decarboxylase (GAD)-Alum vaccine
GAD-Alum: Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.
|
GAD-alum Plus Alum
2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone
GAD-Alum: Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection.
|
Alum Alone
3 injections of Aluminum hydroxide alone
Aluminum hydroxide: Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.
|
|---|---|---|---|
|
Overall Study
STARTED
|
48
|
49
|
48
|
|
Overall Study
COMPLETED
|
46
|
48
|
46
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
2
|
Reasons for withdrawal
| Measure |
GAD-alum
3 injections of Glutamic Acid Decarboxylase (GAD)-Alum vaccine
GAD-Alum: Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.
|
GAD-alum Plus Alum
2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone
GAD-Alum: Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection.
|
Alum Alone
3 injections of Aluminum hydroxide alone
Aluminum hydroxide: Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
|
Overall Study
Non-compliant
|
0
|
1
|
0
|
Baseline Characteristics
Effects of Recombinant Human Glutamic Acid Decarboxylase on the Progression of Type 1 Diabetes in New Onset Subjects
Baseline characteristics by cohort
| Measure |
GAD-alum
n=48 Participants
3 injections of GAD-Alum vaccine
GAD-Alum: Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.
|
GAD-alum Plus Alum
n=49 Participants
2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone
GAD-Alum: Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection.
|
Alum Alone
n=48 Participants
3 injections of Aluminum hydroxide alone
Aluminum hydroxide: Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.
|
Total
n=145 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
17.8 years
STANDARD_DEVIATION 10.3 • n=99 Participants
|
14.8 years
STANDARD_DEVIATION 8.7 • n=107 Participants
|
16.6 years
STANDARD_DEVIATION 9.2 • n=206 Participants
|
16.4 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
64 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
81 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Based on mixed meal tolerance test (MMTT) conducted at the one year visitThe primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes.
Outcome measures
| Measure |
GAD-alum
n=46 Participants
3 injections of GAD-Alum vaccine
GAD-Alum: Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.
|
GAD-alum Plus Alum
n=48 Participants
2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone
GAD-Alum: Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection.
|
Alum Alone
n=46 Participants
3 injections of Aluminum hydroxide alone
Aluminum hydroxide: Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.
|
|---|---|---|---|
|
The Primary Outcome is the Area Under the Stimulated C-peptide Curve (AUC) at the One Year Visit
|
0.448 nmol/L
Interval 0.361 to 0.54
|
0.350 nmol/L
Interval 0.267 to 0.438
|
0.418 nmol/L
Interval 0.333 to 0.508
|
Adverse Events
GAD-alum
Serious events: 5 serious events
Other events: 20 other events
Deaths: 0 deaths
GAD-alum Plus Alum
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
Alum Alone
Serious events: 5 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GAD-alum
n=48 participants at risk
3 injections of GAD-Alum vaccine
GAD-Alum: Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.
|
GAD-alum Plus Alum
n=49 participants at risk
2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone
GAD-Alum: Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection.
|
Alum Alone
n=48 participants at risk
3 injections of Aluminum hydroxide alone
Aluminum hydroxide: Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.
|
|---|---|---|---|
|
Cardiac disorders
Cardiac ischemia/infarction
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/48
|
|
Endocrine disorders
Endocrine - Other
|
0.00%
0/48
|
2.0%
1/49 • Number of events 1
|
0.00%
0/48
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/48
|
2.0%
1/49 • Number of events 1
|
0.00%
0/48
|
|
Infections and infestations
Infection - Other
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphatics - Other
|
0.00%
0/48
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
|
Metabolism and nutrition disorders
Acidosis (metabolic or respiratory)
|
0.00%
0/48
|
2.0%
1/49 • Number of events 1
|
0.00%
0/48
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
0.00%
0/48
|
0.00%
0/49
|
4.2%
2/48 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/48
|
0.00%
0/49
|
4.2%
2/48 • Number of events 2
|
|
Psychiatric disorders
Depression
|
0.00%
0/48
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
|
Nervous system disorders
Neurology - Other
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/48
|
|
Psychiatric disorders
Personality/behavioral
|
0.00%
0/48
|
0.00%
0/49
|
2.1%
1/48 • Number of events 1
|
|
Surgical and medical procedures
Intra-operative Injury - Other
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/48
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/48
|
Other adverse events
| Measure |
GAD-alum
n=48 participants at risk
3 injections of GAD-Alum vaccine
GAD-Alum: Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.
|
GAD-alum Plus Alum
n=49 participants at risk
2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone
GAD-Alum: Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection.
|
Alum Alone
n=48 participants at risk
3 injections of Aluminum hydroxide alone
Aluminum hydroxide: Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Auditory/Ear- Other
|
0.00%
0/48
|
6.1%
3/49 • Number of events 3
|
0.00%
0/48
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
6.2%
3/48 • Number of events 3
|
0.00%
0/49
|
0.00%
0/48
|
|
Skin and subcutaneous tissue disorders
Injection site reaction/extravasation changes
|
8.3%
4/48 • Number of events 8
|
14.3%
7/49 • Number of events 13
|
0.00%
0/48
|
|
Endocrine disorders
Endocrine - Other
|
0.00%
0/48
|
6.1%
3/49 • Number of events 4
|
0.00%
0/48
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/48
|
6.1%
3/49 • Number of events 3
|
6.2%
3/48 • Number of events 3
|
|
Infections and infestations
Infection - Other
|
20.8%
10/48 • Number of events 14
|
20.4%
10/49 • Number of events 13
|
20.8%
10/48 • Number of events 16
|
|
Infections and infestations
Sinus Infection with unknown ANC
|
6.2%
3/48 • Number of events 4
|
0.00%
0/49
|
0.00%
0/48
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other
|
0.00%
0/48
|
6.1%
3/49 • Number of events 6
|
20.8%
10/48 • Number of events 10
|
|
General disorders
Pain- Abdomen NOS
|
0.00%
0/48
|
6.1%
3/49 • Number of events 3
|
0.00%
0/48
|
|
General disorders
Pain - Other
|
0.00%
0/48
|
0.00%
0/49
|
6.2%
3/48 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/48
|
0.00%
0/49
|
6.2%
3/48 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other
|
0.00%
0/48
|
12.2%
6/49 • Number of events 9
|
0.00%
0/48
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place