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Prevention Trial: Immune-tolerance With Alum-GAD (Diamyd) and Vitamin D3 to Children With Multiple Islet Autoantibodies (DiAPREV-IT2)

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ClinicalTrials.gov Identifier: NCT02387164
Recruitment Status : Terminated (The study was interrupted early and terminated when only 26 out of 80 patients were enrolled due to new clinical study results indicating that the current study would not be informative.)
First Posted : March 12, 2015
Results First Posted : October 27, 2020
Last Update Posted : November 17, 2020
Sponsor:
Collaborator:
Region Skane
Information provided by (Responsible Party):
Helena Elding Larsson, Lund University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Diabetes Mellitus, Type 1
Prediabetic State
Interventions Drug: Alum-GAD
Drug: Vitamin D3
Enrollment 26
Recruitment Details  
Pre-assignment Details 29 patients were screened for the study and 26 entered the study. Three patients were screening failures.
Arm/Group Title Alum-GAD, Vitamin D3 Placebo, Vitamin D3
Hide Arm/Group Description

Two doses à 20 microgram of subcutaneous alum-GAD (Diamyd), 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years.

Alum-GAD (Glutamic Acid Decarboxylase): Two doses à 20 microgram 30 days apart subcutaneously administrated

Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily

Two doses of subcutaneous placebo, 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years

Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily

Period Title: Overall Study
Started 13 13
Completed 10 11
Not Completed 3 2
Reason Not Completed
Lost to Follow-up             2             0
Diagnosed             1             2
Arm/Group Title Alum-GAD, Vitamin D3 Placebo, Vitamin D3 Total
Hide Arm/Group Description

Two doses à 20 microgram of subcutaneous alum-GAD (Diamyd), 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years.

Alum-GAD: Two doses à 20 microgram 30 days apart subcutaneously administrated

Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily

Two doses of subcutaneous placebo, 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years

Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily

Total of all reporting groups
Overall Number of Baseline Participants 13 13 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
<=18 years
13
 100.0%
13
 100.0%
26
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 13 participants 26 participants
9.0  (2.89) 9.4  (2.73) 9.2  (2.76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Female
7
  53.8%
4
  30.8%
11
  42.3%
Male
6
  46.2%
9
  69.2%
15
  57.7%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[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 13 participants 13 participants 26 participants
13 13 26
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 13 participants 13 participants 26 participants
33.7  (14.51) 36.6  (14.99) 35.1  (14.53)
Celiac disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Yes
2
  15.4%
0
   0.0%
2
   7.7%
No
11
  84.6%
13
 100.0%
24
  92.3%
Thyroid disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Yes
0
   0.0%
0
   0.0%
0
   0.0%
No
13
 100.0%
13
 100.0%
26
 100.0%
Relatedness  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
First degree relative diagnosed with type 1 diabetes
4
  30.8%
2
  15.4%
6
  23.1%
General population (no relative diagnosed with type 1 diabetes)
9
  69.2%
11
  84.6%
20
  76.9%
1.Primary Outcome
Title Type 1 Diabetes Month 24
Hide Description Number of patients diagnosed with type 1 diabetes according to ADA (American Diabetes Association) criteria in each study arm month 24
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alum-GAD, Vitamin D3 Placebo, Vitamin D3
Hide Arm/Group Description:

Two doses à 20 microgram of subcutaneous alum-GAD (Diamyd), 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years.

Alum-GAD: Two doses à 20 microgram 30 days apart subcutaneously administrated

Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily

Two doses of subcutaneous placebo, 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years

Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily

Overall Number of Participants Analyzed 13 13
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
1
   7.7%
2
  15.4%
No
12
  92.3%
11
  84.6%
2.Primary Outcome
Title Type 1 Diabetes Status Overall
Hide Description Number of patients diagnosed with type 1 diabetes according to ADA (American Diabetes Association) criteria in each study arm overall. Including one patient diagnosed shortly after the month 24 visit.
Time Frame Over the entire study period up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alum-GAD, Vitamin D3 Placebo, Vitamin D3
Hide Arm/Group Description:

Two doses à 20 microgram of subcutaneous alum-GAD (Diamyd), 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years.

Alum-GAD: Two doses à 20 microgram 30 days apart subcutaneously administrated

Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily

Two doses of subcutaneous placebo, 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years

Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily

Overall Number of Participants Analyzed 13 13
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
2
  15.4%
2
  15.4%
No
11
  84.6%
11
  84.6%
3.Secondary Outcome
Title Number of Patients Developing Impaired Glucose Metabolism Until Month 18
Hide Description

Change in metabolic status from normal to impaired glucose metabolism during follow-up in the group of children with normal glucose metabolism at baseline screening.

Impaired glucose metabolism is defined as a) fasting plasma glucose 6.1 mmol/L or more, b) maximum plasma glucose 30, 60, 90 min during oral glucose tolerance test (OGTT) 11.1 mmol/L or more, c) 120 min plasma glucose on OGTT 7.8 mmol/L or more, d) HbA1c 39 mmol/L or more.

Time Frame During 18 months follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with normal glucose at baseline and glucose measured at month 18 are included.
Arm/Group Title Alum-GAD, Vitamin D3 Placebo, Vitamin D3
Hide Arm/Group Description:

Two doses à 20 microgram of subcutaneous alum-GAD (Diamyd), 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years.

Alum-GAD: Two doses à 20 microgram 30 days apart subcutaneously administrated

Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily

Two doses of subcutaneous placebo, 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years

Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily

Overall Number of Participants Analyzed 8 6
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
3
  37.5%
1
  16.7%
No
5
  62.5%
5
  83.3%
4.Secondary Outcome
Title Number of Patients With Progressive Impaired Glucose Metabolism Until Month 18
Hide Description

Number of patients who have progression from already impaired glucose metabolism from one or several criteria to additional signs of reduced glucose metabolism (within children with impaired glucose metabolism at screening).

Impaired glucose metabolism is defined as a) fasting plasma glucose 6.1 mmol/L or more, b) maximum plasma glucose 30, 60, 90 min during oral glucose tolerance test (OGTT) 11.1 mmol/L or more, c) 120 min plasma glucose on OGTT 7.8 mmol/L or more, d) HbA1c 39 mmol/L or more.

Time Frame During 18 months follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with impaired glucose at baseline and glucose measured at month 18 are included.
Arm/Group Title Alum-GAD, Vitamin D3 Placebo, Vitamin D3
Hide Arm/Group Description:

Two doses à 20 microgram of subcutaneous alum-GAD (Diamyd), 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years.

Alum-GAD: Two doses à 20 microgram 30 days apart subcutaneously administrated

Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily

Two doses of subcutaneous placebo, 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years

Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily

Overall Number of Participants Analyzed 2 4
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
1
  50.0%
0
   0.0%
No
1
  50.0%
4
 100.0%
5.Secondary Outcome
Title Injection Site Reactions Day 1
Hide Description Number of patients experiencing injection site reactions at day 1
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alum-GAD, Vitamin D3 Placebo, Vitamin D3
Hide Arm/Group Description:

Two doses à 20 microgram of subcutaneous alum-GAD (Diamyd), 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years.

Alum-GAD: Two doses à 20 microgram 30 days apart subcutaneously administrated

Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily

Two doses of subcutaneous placebo, 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years

Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily

Overall Number of Participants Analyzed 13 13
Measure Type: Number
Unit of Measure: participants
Erythema 0 0
Haematoma 0 0
Itching 0 0
Oedema 0 0
Pain 0 0
Tenderness 0 0
6.Secondary Outcome
Title Injection Site Reactions Month 1
Hide Description Number of patients experiencing injection site reactions at month 1
Time Frame Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alum-GAD, Vitamin D3 Placebo, Vitamin D3
Hide Arm/Group Description:

Two doses à 20 microgram of subcutaneous alum-GAD (Diamyd), 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years.

Alum-GAD: Two doses à 20 microgram 30 days apart subcutaneously administrated

Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily

Two doses of subcutaneous placebo, 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years

Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily

Overall Number of Participants Analyzed 13 13
Measure Type: Number
Unit of Measure: participants
Erythema 1 0
Haematoma 1 0
Itching 0 0
Oedema 2 0
Pain 0 0
Tenderness 0 0
7.Secondary Outcome
Title Change From Baseline in GADA Month 1
Hide Description Change from baseline to month 1 in GADA (Glutamic Acid Decarboxylase Antibodies) titers
Time Frame Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with GADA measured both at baseline and month 1 are included.
Arm/Group Title Alum-GAD, Vitamin D3 Placebo, Vitamin D3
Hide Arm/Group Description:

Two doses à 20 microgram of subcutaneous alum-GAD (Diamyd), 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years.

Alum-GAD: Two doses à 20 microgram 30 days apart subcutaneously administrated

Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily

Two doses of subcutaneous placebo, 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years

Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily

Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: U/mL
1619.1  (2608.9) -51.9  (197.8)
8.Secondary Outcome
Title Change From Baseline in GADA Month 12
Hide Description Change from baseline to month 12 in GADA titers
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with GADA measured at baseline and at month 12 are included.
Arm/Group Title Alum-GAD, Vitamin D3 Placebo, Vitamin D3
Hide Arm/Group Description:

Two doses à 20 microgram of subcutaneous alum-GAD (Diamyd), 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years.

Alum-GAD: Two doses à 20 microgram 30 days apart subcutaneously administrated

Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily

Two doses of subcutaneous placebo, 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years

Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: U/mL
7916.9  (10694.55) -120.0  (592.09)
9.Secondary Outcome
Title Change From Baseline in GADA Month 24
Hide Description Change from baseline to month 24 in GADA titers
Time Frame Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with GADA measured at baseline and month 24 are included.
Arm/Group Title Alum-GAD, Vitamin D3 Placebo, Vitamin D3
Hide Arm/Group Description:

Two doses à 20 microgram of subcutaneous alum-GAD (Diamyd), 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years.

Alum-GAD: Two doses à 20 microgram 30 days apart subcutaneously administrated

Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily

Two doses of subcutaneous placebo, 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years

Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily

Overall Number of Participants Analyzed 9 11
Mean (Standard Deviation)
Unit of Measure: U/mL
3216.6  (4628.53) 1062.7  (3380.26)
Time Frame During the entire study period approximately 24 months.
Adverse Event Reporting Description At each study visit the investigator asked for any adverse events and recorded them in the CRF (Case Report Form).
 
Arm/Group Title Alum-GAD, Vitamin D3 Placebo, Vitamin D3
Hide Arm/Group Description

Two doses à 20 microgram of subcutaneous alum-GAD (Diamyd), 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years.

Alum-GAD: Two doses à 20 microgram 30 days apart subcutaneously administrated

Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily

Two doses of subcutaneous placebo, 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years

Vitamin D3: 2000 Units (IE) (50 microgram) vitamin D3 daily

All-Cause Mortality
Alum-GAD, Vitamin D3 Placebo, Vitamin D3
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)      0/13 (0.00%)    
Hide Serious Adverse Events
Alum-GAD, Vitamin D3 Placebo, Vitamin D3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/13 (7.69%)      1/13 (7.69%)    
Injury, poisoning and procedural complications     
Upper limb fracture  1  0/13 (0.00%)  0 1/13 (7.69%)  1
Renal and urinary disorders     
Post streptococcal glomerulonephritis  1  1/13 (7.69%)  1 0/13 (0.00%)  0
1
Term from vocabulary, MedDRA (23.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Alum-GAD, Vitamin D3 Placebo, Vitamin D3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/13 (92.31%)      12/13 (92.31%)    
Ear and labyrinth disorders     
Ear pain  1  1/13 (7.69%)  2 1/13 (7.69%)  1
Vertigo  1  0/13 (0.00%)  0 1/13 (7.69%)  1
Gastrointestinal disorders     
Vomiting  1  3/13 (23.08%)  3 2/13 (15.38%)  2
Abdominal pain upper  1  1/13 (7.69%)  1 1/13 (7.69%)  1
Constipation  1  1/13 (7.69%)  1 0/13 (0.00%)  0
Diarrhoea  1  1/13 (7.69%)  1 1/13 (7.69%)  1
Food poisoning  1  1/13 (7.69%)  1 0/13 (0.00%)  0
Nausea  1  0/13 (0.00%)  0 2/13 (15.38%)  2
Abdominal pain  1  0/13 (0.00%)  0 1/13 (7.69%)  1
General disorders     
Pyrexia  1  4/13 (30.77%)  6 5/13 (38.46%)  11
Pain  1  2/13 (15.38%)  3 0/13 (0.00%)  0
Fatigue  1  0/13 (0.00%)  0 1/13 (7.69%)  1
Injection site rash  1  0/13 (0.00%)  0 1/13 (7.69%)  1
Immune system disorders     
Hypersensitivity  1  1/13 (7.69%)  1 0/13 (0.00%)  0
Seasonal allergy  1  1/13 (7.69%)  1 1/13 (7.69%)  2
Infections and infestations     
Nasopharyngitis  1  10/13 (76.92%)  49 9/13 (69.23%)  20
Ear infection  1  3/13 (23.08%)  3 1/13 (7.69%)  1
Gastroenteritis  1  3/13 (23.08%)  3 1/13 (7.69%)  3
Influenza  1  2/13 (15.38%)  3 1/13 (7.69%)  1
Pharyngitis  1  2/13 (15.38%)  2 0/13 (0.00%)  0
Otitis media  1  1/13 (7.69%)  1 1/13 (7.69%)  1
Tooth infection  1  1/13 (7.69%)  1 0/13 (0.00%)  0
Urinary tract infection  1  1/13 (7.69%)  1 0/13 (0.00%)  0
Varicella  1  1/13 (7.69%)  1 0/13 (0.00%)  0
Viral infection  1  1/13 (7.69%)  1 1/13 (7.69%)  1
Conjunctivitis  1  0/13 (0.00%)  0 1/13 (7.69%)  1
Enterobiasis  1  0/13 (0.00%)  0 1/13 (7.69%)  2
Febrile infection  1  0/13 (0.00%)  0 1/13 (7.69%)  1
Impetigo  1  0/13 (0.00%)  0 1/13 (7.69%)  1
Injury, poisoning and procedural complications     
Limb injury  1  1/13 (7.69%)  1 0/13 (0.00%)  0
Upper limb fracture  1  1/13 (7.69%)  1 0/13 (0.00%)  0
Injury  1  0/13 (0.00%)  0 1/13 (7.69%)  1
Musculoskeletal and connective tissue disorders     
Growing pains  1  1/13 (7.69%)  1 0/13 (0.00%)  0
Pain in extremity  1  0/13 (0.00%)  0 1/13 (7.69%)  2
Nervous system disorders     
Headache  1  5/13 (38.46%)  13 3/13 (23.08%)  9
Migraine  1  1/13 (7.69%)  2 0/13 (0.00%)  0
Psychiatric disorders     
Attention deficit/hyperactivit  1  1/13 (7.69%)  1 1/13 (7.69%)  1
Depression  1  1/13 (7.69%)  2 0/13 (0.00%)  0
Insomnia  1  1/13 (7.69%)  1 0/13 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain  1  3/13 (23.08%)  3 1/13 (7.69%)  2
Cough  1  0/13 (0.00%)  0 1/13 (7.69%)  1
Skin and subcutaneous tissue disorders     
Rash  1  1/13 (7.69%)  1 0/13 (0.00%)  0
Urticaria  1  1/13 (7.69%)  1 0/13 (0.00%)  0
1
Term from vocabulary, MedDRA (23.0)
Indicates events were collected by systematic assessment
This study was interrupted early and terminated when only 26 out of 80 patients were enrolled. The patients were followed for 2 years rather than the planned 5 years.
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: Helena Elding Larsson
Organization: Skåne University Hospital
Phone: +4640337676
EMail: helena.larsson@med.lu.se
Publications:
Ludvigsson J, Krisky D, Casas R, Battelino T, Castaño L, Greening J, Kordonouri O, Otonkoski T, Pozzilli P, Robert JJ, Veeze HJ, Palmer J, Samuelsson U, Elding Larsson H, Åman J, Kärdell G, Neiderud Helsingborg J, Lundström G, Albinsson E, Carlsson A, Nordvall M, Fors H, Arvidsson CG, Edvardson S, Hanås R, Larsson K, Rathsman B, Forsgren H, Desaix H, Forsander G, Nilsson NÖ, Åkesson CG, Keskinen P, Veijola R, Talvitie T, Raile K, Kapellen T, Burger W, Neu A, Engelsberger I, Heidtmann B, Bechtold S, Leslie D, Chiarelli F, Cicognani A, Chiumello G, Cerutti F, Zuccotti GV, Gomez Gila A, Rica I, Barrio R, Clemente M, López Garcia MJ, Rodriguez M, Gonzalez I, Lopez JP, Oyarzabal M, Reeser HM, Nuboer R, Stouthart P, Bratina N, Bratanic N, de Kerdanet M, Weill J, Ser N, Barat P, Bertrand AM, Carel JC, Reynaud R, Coutant R, Baron S. GAD65 antigen therapy in recently diagnosed type 1 diabetes mellitus. N Engl J Med. 2012 Feb 2;366(5):433-42. doi: 10.1056/NEJMoa1107096.
Layout table for additonal information
Responsible Party: Helena Elding Larsson, Lund University
ClinicalTrials.gov Identifier: NCT02387164    
Other Study ID Numbers: DiAPREV/2014
First Submitted: March 5, 2015
First Posted: March 12, 2015
Results First Submitted: September 10, 2020
Results First Posted: October 27, 2020
Last Update Posted: November 17, 2020