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GAD-Alum (Diamyd) Administered Into Lymph Nodes in Combination With Vitamin D in Type 1 Diabetes (DIAGNODE-1) (DIAGNODE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02352974
Recruitment Status : Completed
First Posted : February 2, 2015
Results First Posted : April 27, 2020
Last Update Posted : April 27, 2020
Sponsor:
Collaborators:
Swedish Child Diabetes Foundation
Ostergotland County Council, Sweden
Diamyd Medical AB
Information provided by (Responsible Party):
Johnny Ludvigsson, Linkoeping University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 1
Interventions Drug: GAD-Alum
Drug: Vitamin D
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GAD-Alum+Vitamin D
Hide Arm/Group Description

GAD(Glutamic acid decarboxylase)-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals

Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days

GAD-Alum

Vitamin D

Period Title: Main Study
Started 12
Completed 12
Not Completed 0
Period Title: Extension
Started 3 [1]
Completed 3
Not Completed 0
[1]
Only 3 out of the 12 patients who completed the main study continued in to the extension period.
Arm/Group Title GAD-Alum+Vitamin D
Hide Arm/Group Description

GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals

Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days

GAD-Alum

Vitamin D

Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
4
  33.3%
Between 18 and 65 years
8
  66.7%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
18.8  (4.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
4
  33.3%
Male
8
  66.7%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Sweden Number Analyzed 12 participants
12
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 12 participants
64.0  (13.6)
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 12 participants
21.1  (3.8)
Type 1 diabetes duration  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 12 participants
65.1  (55.1)
GADA (Antibodies to GAD with molecular mass 65,000)  
Mean (Standard Deviation)
Unit of measure:  U/mL^2
Number Analyzed 12 participants
4067.1  (8491.6)
Weighted C-peptide  
Mean (Standard Deviation)
Unit of measure:  nmol/L
Number Analyzed 12 participants
0.55  (0.19)
90-minute C-peptide  
Mean (Standard Deviation)
Unit of measure:  nmol/L
Number Analyzed 12 participants
0.67  (0.19)
Fasting C-peptide  
Mean (Standard Deviation)
Unit of measure:  nmol/L
Number Analyzed 12 participants
0.27  (0.08)
HbA1c  
Mean (Standard Deviation)
Unit of measure:  Mmol/mol
Number Analyzed 12 participants
67.17  (28.17)
Average insulin dose/kg/24 h  
Mean (Standard Deviation)
Unit of measure:  IU
Number Analyzed 12 participants
0.40  (0.20)
IDAA1c  
Mean (Standard Deviation)
Unit of measure:  IU/kg/day
Number Analyzed 12 participants
9.91  (3.10)
1.Primary Outcome
Title Number of Subjects With Injection Site Reactions Month 1
Hide Description Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching)
Time Frame Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GAD-Alum+Vitamin D
Hide Arm/Group Description:

GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals

Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days

GAD-Alum

Vitamin D

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
Erythema
0
   0.0%
Oedema
0
   0.0%
Haematoma
0
   0.0%
Tenderness
1
   8.3%
Pain
0
   0.0%
Itching
0
   0.0%
Other
0
   0.0%
2.Primary Outcome
Title Number of Subjects With Injection Site Reactions Month 2
Hide Description Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching)
Time Frame Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GAD-Alum+Vitamin D
Hide Arm/Group Description:

GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals

Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days

GAD-Alum

Vitamin D

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
Erythema
0
   0.0%
Oedema
0
   0.0%
Haematoma
0
   0.0%
Tenderness
1
   8.3%
Pain
0
   0.0%
Itching
0
   0.0%
Other
0
   0.0%
3.Primary Outcome
Title Number of Subjects With Injection Site Reactions Month 3
Hide Description Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching)
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GAD-Alum+Vitamin D
Hide Arm/Group Description:

GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals

Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days

GAD-Alum

Vitamin D

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
Erythema
0
   0.0%
Oedema
0
   0.0%
Haematoma
0
   0.0%
Tenderness
2
  16.7%
Pain
0
   0.0%
Itching
0
   0.0%
Other
0
   0.0%
4.Primary Outcome
Title Number of Subjects With Injection Site Reactions Month 32
Hide Description Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching)
Time Frame Month 32, extension period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GAD-Alum+Vitamin D
Hide Arm/Group Description:

GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals

Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days

GAD-Alum

Vitamin D

Overall Number of Participants Analyzed 3
Measure Type: Count of Participants
Unit of Measure: Participants
Erythema
0
   0.0%
Oedema
0
   0.0%
Haematoma
0
   0.0%
Tenderness
0
   0.0%
Pain
0
   0.0%
Itching
0
   0.0%
Other
0
   0.0%
5.Secondary Outcome
Title Mean Change in C-peptide AUC (Area Under the Curve) (Mean 120min) Value, Month 15
Hide Description

Change from baseline to month 15 in C-peptide AUC (Area Under the Curve) (mean 120min) value

AUC (mean 120min) (nmol/L) is the C-peptide AUC during an MMTT (nmol/L*minutes) divided by the duration of the MMTT (minutes) i.e. C-peptide weighted average concentration

Time Frame Baseline to month 15 at 0, 30, 60, 90, 120 minutes post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GAD-Alum+Vitamin D
Hide Arm/Group Description:

GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals

Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days

GAD-Alum

Vitamin D

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: nmol/L
-0.11  (0.12)
6.Secondary Outcome
Title Mean Change in C-peptide AUC(Mean 120min) Value, Month 30
Hide Description

Change from baseline to month 30 in C-peptide AUC(mean 120min) value

AUC (mean 120min) (nmol/L) is the C-peptide AUC during an MMTT (nmol/L*minutes) divided by the duration of the MMTT (minutes) i.e. C-peptide weighted average concentration

Time Frame Baseline to month 30 at 0, 30, 60, 90, 120 minutes post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GAD-Alum+Vitamin D
Hide Arm/Group Description:

GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals

Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days

GAD-Alum

Vitamin D

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: nmol/L
-0.22  (0.16)
7.Secondary Outcome
Title Mean Change in C-peptide AUC(Mean 120min) Value, Month 43
Hide Description

Change from baseline to month 43 in C-peptide AUC(mean 120min) value

AUC (mean 120min) (nmol/L) is the C-peptide AUC during an MMTT (nmol/L*minutes) divided by the duration of the MMTT (minutes) i.e. C-peptide weighted average concentration

Time Frame Baseline to month 43, extension period at 0, 30, 60, 90, 120 minutes post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GAD-Alum+Vitamin D
Hide Arm/Group Description:

GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals

Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days

GAD-Alum

Vitamin D

Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: nmol/L
-0.13  (0.05)
8.Secondary Outcome
Title Mean Change in C-peptide 90-minute Value, Month 15
Hide Description Change from baseline to month 15 in C-peptide 90-minute value
Time Frame Baseline to month 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GAD-Alum+Vitamin D
Hide Arm/Group Description:

GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals

Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days

GAD-Alum

Vitamin D

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: nmol/L
-0.16  (0.15)
9.Secondary Outcome
Title Mean Change in C-peptide 90-minute Value, Month 30
Hide Description Change from baseline to month 30 in C-peptide 90-minute value
Time Frame Baseline to month 30
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GAD-Alum+Vitamin D
Hide Arm/Group Description:

GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals

Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days

GAD-Alum

Vitamin D

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: nmol/L
-0.29  (0.17)
10.Secondary Outcome
Title Mean Change in C-peptide 90-minute Value, Month 43
Hide Description Change from baseline to month 43 in C-peptide 90-minute value
Time Frame Baseline to month 43, extension period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GAD-Alum+Vitamin D
Hide Arm/Group Description:

GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals

Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days

GAD-Alum

Vitamin D

Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: nmol/L
-0.16  (0.03)
11.Secondary Outcome
Title Mean Change in Fasting C-peptide Value, Month 15
Hide Description Change from baseline to month 15 in fasting C-peptide value
Time Frame Baseline to month 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GAD-Alum+Vitamin D
Hide Arm/Group Description:

GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals

Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days

GAD-Alum

Vitamin D

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: nmol/L
-0.03  (0.12)
12.Secondary Outcome
Title Mean Change in Fasting C-peptide Value, Month 30
Hide Description Change from baseline to month 30 in fasting C-peptide value
Time Frame Baseline to month 30
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GAD-Alum+Vitamin D
Hide Arm/Group Description:

GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals

Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days

GAD-Alum

Vitamin D

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: nmol/L
-0.10  (0.12)
13.Secondary Outcome
Title Mean Change in Fasting C-peptide Value, Month 43
Hide Description Change from baseline to month 43 in fasting C-peptide value
Time Frame Baseline to month 43, extension period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GAD-Alum+Vitamin D
Hide Arm/Group Description:

GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals

Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days

GAD-Alum

Vitamin D

Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: nmol/L
-0.07  (0.04)
14.Secondary Outcome
Title Mean Change in HbA1c, Month 15
Hide Description Change from baseline to month 15 in HbA1c
Time Frame Baseline to month 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GAD-Alum+Vitamin D
Hide Arm/Group Description:

GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals

Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days

GAD-Alum

Vitamin D

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: mmol/mol
-14.25  (18.91)
15.Secondary Outcome
Title Mean Change in HbA1c, Month 30
Hide Description Change from baseline to month 30 in HbA1c
Time Frame Baseline to month 30
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GAD-Alum+Vitamin D
Hide Arm/Group Description:

GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals

Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days

GAD-Alum

Vitamin D

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: mmol/mol
-10.67  (18.67)
16.Secondary Outcome
Title Mean Change in HbA1c, Month 43
Hide Description Change from baseline to month 43 in HbA1c
Time Frame Baseline to month 43, extension period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GAD-Alum+Vitamin D
Hide Arm/Group Description:

GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals

Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days

GAD-Alum

Vitamin D

Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: mmol/mol
-30.67  (21.22)
17.Secondary Outcome
Title External Insulin Dose, Baseline
Hide Description External insulin dose at baseline
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GAD-Alum+Vitamin D
Hide Arm/Group Description:

GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals

Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days

GAD-Alum

Vitamin D

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: IU/kg/day
0.36  (0.13)
18.Secondary Outcome
Title External Insulin Dose, Month 15
Hide Description External insulin dose at month 15
Time Frame Month 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GAD-Alum+Vitamin D
Hide Arm/Group Description:

GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals

Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days

GAD-Alum

Vitamin D

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: IU/kg/day
0.34  (0.20)
19.Secondary Outcome
Title External Insulin Dose, Month 30
Hide Description External insulin dose at month 30
Time Frame Month 30
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GAD-Alum+Vitamin D
Hide Arm/Group Description:

GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals

Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days

GAD-Alum

Vitamin D

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: IU/kg/day
0.44  (0.22)
20.Secondary Outcome
Title External Insulin Dose, Month 43
Hide Description External insulin dose at month 43
Time Frame Month 43, extension period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GAD-Alum+Vitamin D
Hide Arm/Group Description:

GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals

Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days

GAD-Alum

Vitamin D

Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: IU/kg/day
0.25  (0.02)
21.Secondary Outcome
Title Mean IDAA1c Values, Baseline
Hide Description Insulin dose-adjusted HbA1c (IDAA1c)
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GAD-Alum+Vitamin D
Hide Arm/Group Description:

GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals

Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days

GAD-Alum

Vitamin D

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: IU/kg/day
9.00  (1.89)
22.Secondary Outcome
Title Mean IDAA1c Values, Month 15
Hide Description Insulin dose-adjusted HbA1c (IDAA1c)
Time Frame Month 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GAD-Alum+Vitamin D
Hide Arm/Group Description:

GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals

Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days

GAD-Alum

Vitamin D

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: IU/kg/day
7.64  (0.99)
23.Secondary Outcome
Title Mean IDAA1c Values, Month 30
Hide Description Insulin dose-adjusted HbA1c (IDAA1c)
Time Frame Month 30
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GAD-Alum+Vitamin D
Hide Arm/Group Description:

GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals

Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days

GAD-Alum

Vitamin D

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: IU/kg/day
8.36  (1.28)
24.Secondary Outcome
Title Mean IDAA1c Values, Month 43
Hide Description Insulin dose-adjusted HbA1c (IDAA1c)
Time Frame Month 43, extension period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GAD-Alum+Vitamin D
Hide Arm/Group Description:

GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals

Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days

GAD-Alum

Vitamin D

Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: IU/kg/day
7.11  (0.93)
Time Frame During main study period (baseline to month 30) and extension (month 37 and 43)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GAD-Alum+Vitamin D
Hide Arm/Group Description

GAD-Alum (Diamyd) injected into Lymph Nodes Dosage and interval: One injection of 4 µg Diamyd will be administered into the lymph nodes at three occasions, with one month intervals

Vitamin D (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days

GAD-Alum

Vitamin D

All-Cause Mortality
GAD-Alum+Vitamin D
Affected / at Risk (%)
Total   0/12 (0.00%)    
Hide Serious Adverse Events
GAD-Alum+Vitamin D
Affected / at Risk (%) # Events
Total   0/12 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
GAD-Alum+Vitamin D
Affected / at Risk (%) # Events
Total   11/12 (91.67%)    
Eye disorders   
Retinopathy * 1  2/12 (16.67%)  2
Gastrointestinal disorders   
Abdominal discomfort * 1  1/12 (8.33%)  1
Abdominal pain upper * 1  1/12 (8.33%)  1
Bowel movement irregularity * 1  1/12 (8.33%)  1
Constipation * 1  1/12 (8.33%)  1
Dysphagia * 1  1/12 (8.33%)  1
Food poisoning * 1  2/12 (16.67%)  2
Gastritis * 1  1/12 (8.33%)  1
Toothache * 1  1/12 (8.33%)  2
Nausea * 1  2/12 (16.67%)  3
General disorders   
Fatigue * 1  1/12 (8.33%)  1
Injection site pain * 1  1/12 (8.33%)  2
Injection site reaction * 1  1/12 (8.33%)  3
Pyrexia * 1  1/12 (8.33%)  2
Immune system disorders   
Seasonal allergy * 1  1/12 (8.33%)  1
Infections and infestations   
Gastroenteritis * 1  2/12 (16.67%)  2
Influenza * 1  2/12 (16.67%)  2
Nasopharyngitis * 1  9/12 (75.00%)  35
Pneumonia * 1  1/12 (8.33%)  1
Rhinitis * 1  1/12 (8.33%)  2
Sinusitis * 1  1/12 (8.33%)  1
Tooth infection * 1  1/12 (8.33%)  2
Viral infection * 1  1/12 (8.33%)  1
Injury, poisoning and procedural complications   
Concussion * 1  1/12 (8.33%)  1
Contusion * 1  1/12 (8.33%)  1
Fibula fracture * 1  1/12 (8.33%)  1
Joint dislocation * 1  1/12 (8.33%)  1
Skin injury * 1  1/12 (8.33%)  1
Investigations   
Hepatic enzyme increased * 1  1/12 (8.33%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  1/12 (8.33%)  1
Plantar fascilitis * 1  1/12 (8.33%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lipoma * 1  1/12 (8.33%)  1
Psychiatric disorders   
Anxiety * 1  2/12 (16.67%)  2
Attention deficit/hyperactivity disorder * 1  1/12 (8.33%)  1
Autism spectrum disorder * 1  2/12 (16.67%)  2
Panic disorder * 1  1/12 (8.33%)  1
Sleep disorder * 1  1/12 (8.33%)  1
Respiratory, thoracic and mediastinal disorders   
Oropharyngeal pain * 1  1/12 (8.33%)  2
Skin and subcutaneous tissue disorders   
Eczema * 1  1/12 (8.33%)  1
Ingrowing nail * 1  1/12 (8.33%)  1
Skin irritation * 1  1/12 (8.33%)  1
Urticaria * 1  1/12 (8.33%)  1
Vascular disorders   
Hypotension * 1  1/12 (8.33%)  1
1
Term from vocabulary, MedDRA (20.1)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Åsa Carlsheimer
Organization: 4Pharma AB
Phone: +4672244516
EMail: asa.carlsheimer@4pharma.com
Layout table for additonal information
Responsible Party: Johnny Ludvigsson, Linkoeping University
ClinicalTrials.gov Identifier: NCT02352974    
Other Study ID Numbers: DIAGNODE-1
First Submitted: December 9, 2014
First Posted: February 2, 2015
Results First Submitted: March 23, 2020
Results First Posted: April 27, 2020
Last Update Posted: April 27, 2020