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Completed

NCT Number: NCT01785108

DIABGAD - Trial to Preserve Insulin Secretion in Type 1 Diabetes Using GAD-Alum (Diamyd) 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

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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

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Halmstad Hospital, Halmstad, Sweden

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

GAD-Alum (Diamyd) 20 µg

Biological

GAD-Alum (Diamyd) 20 µg X 2

Biological

Vitamin D

Drug

Ibuprofen

Drug

Primary outcomes

  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

    Time frame: 6 months, 15 months and 30 months

Secondary outcomes

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

    Time frame: 6, 15 and 30 months

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

    Time frame: 6, 15 and 30 months

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

    Time frame: 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

    Time frame: 6, 15 and 30 months

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

    Time frame: 6, 15 and 30 months

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

    Time frame: 6, 15 and 30 months

Sponsors and collaborators

Lead sponsor

Johnny Ludvigsson

Other Gov

Collaborators

  • Diamyd Medical AB
  • Swedish Child Diabetes Foundation
  • The Research Council of South East Sweden (FORSS)

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Feb 7, 2013
Registry last updated
Aug 23, 2017

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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