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Diabetes Mellitus, Type 1Phase 1DIAGNODENCT02352974

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

A Phase 1 study testing GAD-Alum and Vitamin D in people with Diabetes Mellitus, Type 1, run by Johnny Ludvigsson at 1 site 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 the main study is to: Evaluate the safety of giving GAD-Alum (Glutamic acid decarboxylase) (Diamyd) directly into lymph glands in combination with an oral vitamin D regimen Evaluate how the above mentioned treatments influence the immune system and endogenous insulin secretion. Read more about this study

Who is it for?
Ages 12 to 30 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
GAD-Alum and Vitamin D
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteSweden
Study dates
Jan 2015to Oct 2019
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 12 to 30 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Informed consent given by patients
  • Type 1 diabetes according to the ADA (American Diabetes Association) classification with < 6 months diabetes duration
  • Age 12.00-29.99 years at diagnosis of Type 1 diabetes
  • Fasting C-peptide ≥0.12 nmol/L
  • Pos GADA(Antibodies to GAD with molecular mass 65,000) but < 50 000 random units
  • Females must agree to avoid pregnancy and have a negative urine pregnancy test
  • Patients of childbearing potential must agree to using adequate contraception, until 1 year after the last administration of GAD-Alum.

Who cannot join

  • Previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted)
  • Continuous treatment with any inflammatory drug (sporadic treatment e.g. because of headache or in connection with fever a few days will be accepted)
  • Treatment with any oral or injected anti-diabetic medications other than insulin
  • Treatment with Vitamin D, marketed or not, or unwilling to abstain from such medication during the trial
  • A history of anaemia or significantly abnormal haematology results at screening
  • A history of epilepsy, head trauma or cerebro-vascular accident, or clinical features of continuous motor unit activity in proximal muscles
Show all 17Show fewer
  • Clinically significant history of acute reaction to vaccines or other drugs in the past
  • Treatment with any vaccine, including influenza vaccine, within 4 months prior to planned first study drug dose or planned treatment with any vaccine up to 4 months after the last injection with study drug.
  • Participation in other clinical trials with a new chemical entity within the previous 3 months
  • Inability or unwillingness to comply with the provisions of this protocol
  • A history of alcohol or drug abuse
  • A significant illness other than diabetes within 2 weeks prior to first dosing
  • Known human immunodeficiency virus (HIV) or hepatitis
  • Females who are lactating or pregnant (the possibility of pregnancy must be excluded by urine βHCG (beta-human chorionic gonadotropin) on-site within 24 hours prior to the GAD-Alum treatment)
  • Males or females not willing to use adequate contraception until 1 year after the last GAD-Alum treatment
  • Presence of associated serious disease or condition, including active skin infections that preclude subcutaneous injection, which in the opinion of the investigator makes the patient non-eligible for the study
  • Deemed by the investigator not being able to follow instructions and/or follow the study protocol

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Linköping University

    Linköping

Other trials in Sweden

About this study

Official title: Open Label Pilot Trial in Adults With Recent-onset T1D to Evaluate the Safety, Diabetes Status and Immune Response of GAD-antigen (Diamyd®) Therapy Administered Into Lymph Nodes in Combination With an Oral Vitamin D Regimen

The objectives of the main study is to:

  • Evaluate the safety of giving GAD-Alum (Glutamic acid decarboxylase) (Diamyd) directly into lymph glands in combination with an oral vitamin D regimen
  • Evaluate how the above mentioned treatments influence the immune system and endogenous insulin secretion.

The objective of the sub-study is to:

  • Evaluate safety after a fourth injection with 4 μg GAD-Alum direct into an inguinal lymph gland in 3 adult patients from the main study
  • Evaluate how the above mentioned treatment influences the immune system and endogenous insulin secretion.
Read the detailed description

Eligible patients will be treated with 4 µg GAD-Alum into an inguinal lymph gland at three occasions, with one month intervals in combination with Vitamin D (14 000 IU/week) for 4 months, starting 1 month prior to first GAD-Alum injection.

A sub-study will include three adult patients from the main study and evaluate safety after a fourth injection with 4 μg GAD-Alum into an inguinal lymph gland in combination with oral vitamin D intake. The Prolonged Extension Study Period is 12 months and will start 30,5 months after baseline.

Being tested
GAD-Alum, Vitamin D
Keywords
Diamyd, Diabetes, Juvenile Diabetes, Diabetes Type 1, Type 1 Diabetes, Autoimmune Diabetes, Insulin Dependent Diabetes, Type 1 Diabetes Mellitus, rhGAD65 (Recombinant Human GAD with molecular mass 65,000), GAD65, GAD-Alum, Diabetes Mellitus, Diabetes mellitus Type 1, Glucose Metabolism Disorders, Metabolic Diseases, Vitamin D
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-AlumDrug

    Also called Diamyd

  • Vitamin DDrug

    Also called Calciferol

Study groups in NCT02352974
Study groupRoleWhat they receive
GAD-Alum+Vitamin DExperimentalGAD-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
Receives: Drug: GAD-Alum; Drug: Vitamin D

What is being measured

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

  1. Number of Subjects With Injection Site Reactions Month 1

    Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching)

    Measured: Month 1

  2. Number of Subjects With Injection Site Reactions Month 2

    Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching)

    Measured: Month 2

  3. Number of Subjects With Injection Site Reactions Month 3

    Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching)

    Measured: Month 3

  4. Number of Subjects With Injection Site Reactions Month 32

    Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching)

    Measured: Month 32, extension period

Secondary outcomes (20)

  1. Mean Change in C-peptide AUC (Area Under the Curve) (Mean 120min) Value, Month 15

    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

    Measured: Baseline to month 15 at 0, 30, 60, 90, 120 minutes post-dose

  2. Mean Change in C-peptide AUC(Mean 120min) Value, Month 30

    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

    Measured: Baseline to month 30 at 0, 30, 60, 90, 120 minutes post-dose

  3. Mean Change in C-peptide AUC(Mean 120min) Value, Month 43

    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

    Measured: Baseline to month 43, extension period at 0, 30, 60, 90, 120 minutes post-dose

  4. Mean Change in C-peptide 90-minute Value, Month 15

    Change from baseline to month 15 in C-peptide 90-minute value

    Measured: Baseline to month 15

  5. Mean Change in C-peptide 90-minute Value, Month 30

    Change from baseline to month 30 in C-peptide 90-minute value

    Measured: Baseline to month 30

  6. Mean Change in C-peptide 90-minute Value, Month 43

    Change from baseline to month 43 in C-peptide 90-minute value

    Measured: Baseline to month 43, extension period

  7. Mean Change in Fasting C-peptide Value, Month 15

    Change from baseline to month 15 in fasting C-peptide value

    Measured: Baseline to month 15

  8. Mean Change in Fasting C-peptide Value, Month 30

    Change from baseline to month 30 in fasting C-peptide value

    Measured: Baseline to month 30

  9. Mean Change in Fasting C-peptide Value, Month 43

    Change from baseline to month 43 in fasting C-peptide value

    Measured: Baseline to month 43, extension period

  10. Mean Change in HbA1c, Month 15

    Change from baseline to month 15 in HbA1c

    Measured: Baseline to month 15

  11. Mean Change in HbA1c, Month 30

    Change from baseline to month 30 in HbA1c

    Measured: Baseline to month 30

  12. Mean Change in HbA1c, Month 43

    Change from baseline to month 43 in HbA1c

    Measured: Baseline to month 43, extension period

  13. External Insulin Dose, Baseline

    External insulin dose at baseline

    Measured: Baseline

  14. External Insulin Dose, Month 15

    External insulin dose at month 15

    Measured: Month 15

  15. External Insulin Dose, Month 30

    External insulin dose at month 30

    Measured: Month 30

  16. External Insulin Dose, Month 43

    External insulin dose at month 43

    Measured: Month 43, extension period

  17. Mean IDAA1c Values, Baseline

    Insulin dose-adjusted HbA1c (IDAA1c)

    Measured: Baseline

  18. Mean IDAA1c Values, Month 15

    Insulin dose-adjusted HbA1c (IDAA1c)

    Measured: Month 15

  19. Mean IDAA1c Values, Month 30

    Insulin dose-adjusted HbA1c (IDAA1c)

    Measured: Month 30

  20. Mean IDAA1c Values, Month 43

    Insulin dose-adjusted HbA1c (IDAA1c)

    Measured: Month 43, extension period

Timeline

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

  1. First posted2 Feb 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionOct 2019
  4. Study completionOct 2019

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02352974
Sponsor's protocol ID
DIAGNODE-1
Acronym
DIAGNODE
Status last verified
Apr 2020
First submitted
9 Dec 2014
Last updated
27 Apr 2020
Data monitoring committee
No

Publications

  • Casas R, Dietrich F, Barcenilla H, Tavira B, Wahlberg J, Achenbach P, Ludvigsson J. Glutamic Acid Decarboxylase Injection Into Lymph Nodes: Beta Cell Function and Immune Responses in Recent Onset Type 1 Diabetes Patients. Front Immunol. 2020 Oct 9;11:564921. doi: 10.3389/fimmu.2020.564921. eCollection 2020.

    PubMed 33162978

  • 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 1 study testing GAD-Alum and Vitamin D in people with Diabetes Mellitus, Type 1, run by Johnny Ludvigsson at 1 site in Sweden.

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

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. 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 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Subjects With Injection Site Reactions Month 1 (time frame: Month 1). The study lists 4 primary outcomes in all. 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 NCT02352974, 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 27 Apr 2020.

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