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Diabetes Mellitus, Type 1Phase 2NCT01785108

DIABGAD - Trial to Preserve Insulin Secretion in Type 1 Diabetes Using GAD-Alum (Diamyd) in Combination With Vitamin D and Ibuprofen

A Phase 2 study testing GAD-Alum (Diamyd) 20 µg, GAD-Alum (Diamyd) 20 µg X 2 and Vitamin D in people with Diabetes Mellitus, Type 1, run by Johnny Ludvigsson at 10 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objectives of this study is to 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… Read more about this study

Who is it for?
Ages 10 to 18 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
GAD-Alum (Diamyd) 20 µg, GAD-Alum (Diamyd) 20 µg X 2 and Vitamin D
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
10 sitesSweden
Study dates
Feb 2013to Mar 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Main Inclusion Criteria:

  • Male and female patients between 10 and 18 years of age
  • 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

Main Exclusion Criteria:

  • Treatment with immunosuppressants, continuous anti-inflammatory drug, Vitamin D or any anti-diabetic medications other than insulin
  • 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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Sweden10 sites

  • Halmstad Hospital

    Halmstad, SE-301 85

  • Astrid Lindgren Children's Hospital - Huddinge

    Huddinge, SE-141 86

  • Kalmar Hospital

    Kalmar, SE-391 85

  • Linköping University

    Linköping, SE-581 85

  • Lund University Hospital

    Lund, SE-221 85

  • Skåne University Hospital, UMAS

    Malmö, SE-205 02

  • Örebro University Hospital

    Örebro, SE-701 85

  • Sachsska, Södersjukhuset

    Stockholm, SE-118 83

  • Astrid Lindgren Children's Hospital

    Stockholm, SE-171 76

  • Uddevalla Hospital

    Uddevalla, SE-451 80

Other trials in Sweden

About this study

Official title: Pilot Trial to Preserve Residual Insulin Secretion in Children and Adolescents With Recent Onset Type 1 Diabetes by Using GAD-antigen (Diamyd) Therapy in Combination With Vitamin D and Ibuprofen

The objectives of this study is to

  • 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
Being tested
GAD-Alum (Diamyd) 20 µg, GAD-Alum (Diamyd) 20 µg X 2, Vitamin D, Ibuprofen
Keywords
Diamyd, Diabetes, Juvenile Diabetes, Diabetes type 1, Autoimmune Diabetes, Insulin dependent Diabetes, Type 1 diabetes, Type 1 diabetes mellitus, rhGAD65, GAD, GAD65, GAD-alum, Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Metabolic Diseases, Vitamin D, Ibuprofen
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GAD-Alum (Diamyd) 20 µgBiological

  • GAD-Alum (Diamyd) 20 µg X 2Biological

  • Vitamin DDrug

  • IbuprofenDrug

Study groups in NCT01785108
Study groupRoleWhat they receive
GAD-Alum (Diamyd) 20µg, Vitamin D and IbuprofenActive comparator* 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
Receives: Biological: GAD-Alum (Diamyd) 20 µg; Drug: Vitamin D; Drug: Ibuprofen
GAD-Alum (Diamyd) 20µg and Vitamin DActive comparator* GAD-Alum (Diamyd) 20 µg given twice with one month interval * Vitamin D oral drops, 2000 IU/day, from Day 1 to Day 450
Receives: Biological: GAD-Alum (Diamyd) 20 µg; Drug: Vitamin D
GAD-Alum (Diamyd) 20 µg x 2 and Vitamin DActive comparator* 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
Receives: Biological: GAD-Alum (Diamyd) 20 µg X 2; Drug: Vitamin D
PlaceboPlacebo comparatorNot described
Receives: Biological: GAD-Alum (Diamyd) 20 µg X 2; Drug: Vitamin D; Drug: Ibuprofen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in C-peptide (90 minute value and AUC mean 0-120 min) during a Mixed Meal Tolerance Test from baseline to month 6, 15 and 30

    Measured: 6 months, 15 months and 30 months

Secondary outcomes (6)

  1. Proportion of patients with a stimulated maximum C-peptide level above 0.2 nmol/L

    Measured: 6, 15 and 30 months

  2. Hemoglobin A1c (HbA1c), change between baseline and subsequent visits

    Measured: 6, 15 and 30 months

  3. Exogenous insulin dose per kg body weight and 24 hours, change between baseline and subsequent visits

    Measured: 6, 15 and 30 months

  4. Th2-deviation of cell-mediated immune response seen, e.g. as increased ratio of IL-5, 10, 13 in comparison with IFN-gamma, TNF-alfa, IL-1 beta, IL-17, and increase of T-regulatory cells

    Measured: 6, 15 and 30 months

  5. Decrease in inflammatory markers, e.g. TNF-alfa, IL-1 beta, IL-2, IL-17

    Measured: 6, 15 and 30 months

  6. Fasting C-peptide, change between baseline and month 6, 15 and 30

    Measured: 6, 15 and 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionMar 2017
  4. Study completionMar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01785108
Sponsor's protocol ID
DIABGAD-1
Status last verified
Aug 2017
First submitted
1 Feb 2013
Last updated
23 Aug 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 32802401

  • 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.

    PubMed 30009185

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GAD-Alum (Diamyd) 20 µg, GAD-Alum (Diamyd) 20 µg X 2 and Vitamin D in people with Diabetes Mellitus, Type 1, run by Johnny Ludvigsson at 10 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in C-peptide (90 minute value and AUC mean 0-120 min) during a Mixed Meal Tolerance Test from baseline to month 6, 15 and 30 (time frame: 6 months, 15 months and 30 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01785108, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2017.

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