DIABGAD - Trial to Preserve Insulin Secretion in Type 1 Diabetes Using GAD-Alum (Diamyd) in Combination With Vitamin D and Ibuprofen
NCT ID: NCT01785108
Last Updated: 2017-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2013-02-28
2017-03-31
Brief Summary
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* evaluate the safety and influence of treatment with GAD-Alum (Diamyd) combined with Vitamin D and Ibuprofen on preservation of residual insulin secretion in recently diagnosed Type 1 Diabetes
* evaluate how the above mentioned treatments influence the immune system of the subjects and interact with any viral infections
* evaluate the safety and influence of treatment with double dose of GAD-Alum (Diamyd) plus Vitamin D on the immune system, viral infections, and on preservation of residual insulin secretion in recently diagnosed Type 1 Diabetes
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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GAD-Alum (Diamyd) 20µg, Vitamin D and Ibuprofen
* GAD-Alum (Diamyd) 20 µg given twice with one month interval
* Vitamin D oral drops, 2000 IU/day, from Day 1 to Day 450
* Ibuprofen, 400 mg/day, from Day 1 to Day 90
GAD-Alum (Diamyd) 20 µg
Vitamin D
Ibuprofen
GAD-Alum (Diamyd) 20µg and Vitamin D
* GAD-Alum (Diamyd) 20 µg given twice with one month interval
* Vitamin D oral drops, 2000 IU/day, from Day 1 to Day 450
GAD-Alum (Diamyd) 20 µg
Vitamin D
GAD-Alum (Diamyd) 20 µg x 2 and Vitamin D
* GAD-Alum (Diamyd) 20 µg X 2 given twice with one month interval
* Vitamin D oral drops, 2000 IU/day, from Day 1 to Day 450
GAD-Alum (Diamyd) 20 µg X 2
Vitamin D
Placebo
GAD-Alum (Diamyd) 20 µg X 2
Vitamin D
Ibuprofen
Interventions
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GAD-Alum (Diamyd) 20 µg
GAD-Alum (Diamyd) 20 µg X 2
Vitamin D
Ibuprofen
Eligibility Criteria
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Inclusion Criteria
* Insulin dependent Type 1 Diabetes mellitus diagnosed within the previous 4 months at time of screening
* Fasting C-peptide level at time of screening above or equal to 0.12 nmol/L
* Elevated GAD65 antibodies (GADA) at time of screening
Exclusion Criteria
* A history of certain diseases or conditions (e.g. anemia, HIV, epilepsy, head trauma, neurological diseases or cerebrovascular accident, alcohol or drug abuse etc)
* Treatment with any vaccine within 4 months prior to first planned administration of GAD-Alum/placebo or planned treatment with vaccine up to 4 months after the last injections with GAD-Alum/Placebo, including influenza vaccines
* Participation in other clinical trials with a new chemical entity within the previous 3 months
* Pregnancy or planned pregnancy within 1 year after the last GAD-Alum/placebo dose
* Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study
10 Years
18 Years
ALL
No
Sponsors
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Swedish Child Diabetes Foundation
OTHER
The Research Council of South East Sweden (FORSS)
UNKNOWN
Diamyd Medical AB
INDUSTRY
Johnny Ludvigsson
OTHER_GOV
Responsible Party
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Johnny Ludvigsson
MD, PhD, Professor
Principal Investigators
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Johnny Ludvigsson, MD,PhD,Prof
Role: PRINCIPAL_INVESTIGATOR
Linkoeping University
Locations
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Halmstad Hospital
Halmstad, , Sweden
Astrid Lindgren Children's Hospital - Huddinge
Huddinge, , Sweden
Kalmar Hospital
Kalmar, , Sweden
Linköping University
Linköping, , Sweden
Lund University Hospital
Lund, , Sweden
Skåne University Hospital, UMAS
Malmo, , Sweden
Örebro University Hospital
Örebro, , Sweden
Sachsska, Södersjukhuset
Stockholm, , Sweden
Astrid Lindgren Children's Hospital
Stockholm, , Sweden
Uddevalla Hospital
Uddevalla, , Sweden
Countries
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References
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Ludvigsson J, Routray I, Elluru S, Leanderson P, Larsson HE, Rathsman B, Hanas R, Carlsson A, Ek T, Samuelsson U, Torbjornsdotter T, Aman J, Ortqvist E, Badwal K, Beam C, Casas R. Combined vitamin D, ibuprofen and glutamic acid decarboxylase-alum treatment in recent onset Type I diabetes: lessons from the DIABGAD randomized pilot trial. Future Sci OA. 2020 Jun 23;6(7):FSO604. doi: 10.2144/fsoa-2020-0078.
Tavira B, Barcenilla H, Wahlberg J, Achenbach P, Ludvigsson J, Casas R. Intralymphatic Glutamic Acid Decarboxylase-Alum Administration Induced Th2-Like-Specific Immunomodulation in Responder Patients: A Pilot Clinical Trial in Type 1 Diabetes. J Diabetes Res. 2018 May 24;2018:9391845. doi: 10.1155/2018/9391845. eCollection 2018.
Other Identifiers
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DIABGAD-1
Identifier Type: -
Identifier Source: org_study_id
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