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

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ClinicalTrials.gov Identifier: NCT02352974
Recruitment Status : Active, not recruiting
First Posted : February 2, 2015
Last Update Posted : September 28, 2018
Sponsor:
Collaborators:
Swedish Child Diabetes Foundation
Ostergotland County Council, Sweden
Diamyd Medical AB
Information provided by (Responsible Party):
Johnny Ludvigsson, Linkoeping University

Brief Summary:

The objectives of the main study is to:

  • Evaluate the safety of giving GAD-Alum (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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: GAD-Alum Drug: Vitamin D Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A

GAD-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

Drug: GAD-Alum
Other Name: Diamyd

Drug: Vitamin D



Primary Outcome Measures :
  1. Safety of giving Diamyd directly into lymph glands in combination with an oral vitamin D regimen at Month 6 (main study period) and Month 15 and 30 (extension study period) [ Time Frame: 6 months ]
    Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching); Number of adverse events and number of participants with adverse events; Laboratory measurements (biochemistry and haematology), including Calcium and Vitamin D in serum; Urinalysis (microalbuminuria, creatinine); Physical examinations, including neurological assessments; GAD65AB titer (GADA)


Secondary Outcome Measures :
  1. Change in immune system markers from baseline to Month 6 (main study period) and subsequent visits during the extension study period [ Time Frame: 6 months, 15 and 30 months ]
    Inflammatory markers, (e.g. TNF-alfa, IL-1 beta, IL-2, IL-17); Th2-deviation of cell-mediated immune response seen e.g. as increased ratio IL-5,10, 13 in comparison with IFN-gamma, TNF-alfa, IL-1 beta and IL-17; Regulatory T-cells

  2. C-peptide: Fasting, 90 minute value, and Area Under the Curve (mean 0-120 min) during an MMTT, change from baseline [ Time Frame: 6 months, 15 and 30 months ]
  3. Hemoglobin A1c (HbA1c), change from baseline [ Time Frame: 6 months, 15 and 30 months ]
  4. Exogenous insulin dose per kg body weight and 24 hours, change from baseline [ Time Frame: 6 months, 15 and 30 months ]


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Ages Eligible for Study:   12 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted)
  2. Continuous treatment with any inflammatory drug (sporadic treatment e.g. because of headache or in connection with fever a few days will be accepted)
  3. Treatment with any oral or injected anti-diabetic medications other than insulin
  4. Treatment with Vitamin D, marketed or not, or unwilling to abstain from such medication during the trial
  5. A history of anaemia or significantly abnormal haematology results at screening
  6. A history of epilepsy, head trauma or cerebro-vascular accident, or clinical features of continuous motor unit activity in proximal muscles
  7. Clinically significant history of acute reaction to vaccines or other drugs in the past
  8. 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.
  9. Participation in other clinical trials with a new chemical entity within the previous 3 months
  10. Inability or unwillingness to comply with the provisions of this protocol
  11. A history of alcohol or drug abuse
  12. A significant illness other than diabetes within 2 weeks prior to first dosing
  13. Known human immunodeficiency virus (HIV) or hepatitis
  14. Females who are lactating or pregnant (the possibility of pregnancy must be excluded by urine βHCG on-site within 24 hours prior to the GAD-Alum treatment)
  15. Males or females not willing to use adequate contraception until 1 year after the last GAD-Alum treatment
  16. 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
  17. Deemed by the investigator not being able to follow instructions and/or follow the study protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352974


Locations
Sweden
Linköping University
Linköping, Sweden
Sponsors and Collaborators
Johnny Ludvigsson
Swedish Child Diabetes Foundation
Ostergotland County Council, Sweden
Diamyd Medical AB
Investigators
Principal Investigator: Johnny Ludvigsson, Professor Linkoeping University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johnny Ludvigsson, MD, PhD, Professor, Linkoeping University
ClinicalTrials.gov Identifier: NCT02352974     History of Changes
Other Study ID Numbers: DIAGNODE-1
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018

Keywords provided by Johnny Ludvigsson, Linkoeping University:
Diamyd
Diabetes
Juvenile Diabetes
Diabetes Type 1
Type 1 Diabetes
Autoimmune Diabetes
Insulin Dependent Diabetes
Type 1 Diabetes Mellitus
rhGAD65
GAD65
GAD-Alum
Diabetes Mellitus
Diabetes mellitus Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Vitamin D

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents