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Completed

NCT Number: NCT02352974

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

12 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Linköping University

Linköping, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 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

Treatment and study plan

GAD-Alum

Drug

Other names: Diamyd

Vitamin D

Drug

Other names: Calciferol

Primary outcomes

  1. Number of Subjects With Injection Site Reactions Month 1

    Time frame: Month 1

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

  2. Number of Subjects With Injection Site Reactions Month 2

    Time frame: Month 2

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

  3. Number of Subjects With Injection Site Reactions Month 3

    Time frame: Month 3

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

  4. Number of Subjects With Injection Site Reactions Month 32

    Time frame: Month 32, extension period

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

Secondary outcomes

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

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

    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

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

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

    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

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

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

    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

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

    Time frame: Baseline to month 15

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

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

    Time frame: Baseline to month 30

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

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

    Time frame: Baseline to month 43, extension period

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

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

    Time frame: Baseline to month 15

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

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

    Time frame: Baseline to month 30

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

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

    Time frame: Baseline to month 43, extension period

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

  10. Mean Change in HbA1c, Month 15

    Time frame: Baseline to month 15

    Change from baseline to month 15 in HbA1c

  11. Mean Change in HbA1c, Month 30

    Time frame: Baseline to month 30

    Change from baseline to month 30 in HbA1c

  12. Mean Change in HbA1c, Month 43

    Time frame: Baseline to month 43, extension period

    Change from baseline to month 43 in HbA1c

  13. External Insulin Dose, Baseline

    Time frame: Baseline

    External insulin dose at baseline

  14. External Insulin Dose, Month 15

    Time frame: Month 15

    External insulin dose at month 15

  15. External Insulin Dose, Month 30

    Time frame: Month 30

    External insulin dose at month 30

  16. External Insulin Dose, Month 43

    Time frame: Month 43, extension period

    External insulin dose at month 43

  17. Mean IDAA1c Values, Baseline

    Time frame: Baseline

    Insulin dose-adjusted HbA1c (IDAA1c)

  18. Mean IDAA1c Values, Month 15

    Time frame: Month 15

    Insulin dose-adjusted HbA1c (IDAA1c)

  19. Mean IDAA1c Values, Month 30

    Time frame: Month 30

    Insulin dose-adjusted HbA1c (IDAA1c)

  20. Mean IDAA1c Values, Month 43

    Time frame: Month 43, extension period

    Insulin dose-adjusted HbA1c (IDAA1c)

Sponsors and collaborators

Lead sponsor

Johnny Ludvigsson

Other Gov

Collaborators

  • Diamyd Medical AB
  • Ostergotland County Council, Sweden
  • Swedish Child Diabetes Foundation

Registry information

Official study 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

Acronym: DIAGNODE

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Feb 2, 2015
Registry last updated
Apr 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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