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

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ClinicalTrials.gov Identifier: NCT01785108
Recruitment Status : Completed
First Posted : February 7, 2013
Last Update Posted : August 23, 2017
Sponsor:
Collaborators:
Swedish Child Diabetes Foundation
The Research Council of South East Sweden (FORSS)
Diamyd Medical AB
Information provided by (Responsible Party):
Johnny Ludvigsson, Linkoeping University

Study Description
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Brief 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 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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Biological: GAD-Alum (Diamyd) 20 µg Biological: GAD-Alum (Diamyd) 20 µg X 2 Drug: Vitamin D Drug: Ibuprofen Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : February 2013
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: GAD-Alum (Diamyd) 20µg, Vitamin D and Ibuprofen
  • 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
 Biological: GAD-Alum (Diamyd) 20 µg
Drug: Vitamin D
Drug: Ibuprofen
Active Comparator: GAD-Alum (Diamyd) 20µg and Vitamin D
  • GAD-Alum (Diamyd) 20 µg given twice with one month interval
  • Vitamin D oral drops, 2000 IU/day, from Day 1 to Day 450
 Biological: GAD-Alum (Diamyd) 20 µg
Drug: Vitamin D
Active Comparator: GAD-Alum (Diamyd) 20 µg x 2 and Vitamin D
  • 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
 Biological: GAD-Alum (Diamyd) 20 µg X 2
Drug: Vitamin D
Placebo Comparator: Placebo Biological: GAD-Alum (Diamyd) 20 µg X 2
Drug: Vitamin D
Drug: Ibuprofen


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT01785108


Locations
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Sweden
Halmstad Hospital
Halmstad, Sweden, SE-301 85
Astrid Lindgren Children's Hospital - Huddinge
Huddinge, Sweden, SE-141 86
Kalmar Hospital
Kalmar, Sweden, SE-391 85
Linköping University
Linköping, Sweden, SE-581 85
Lund University Hospital
Lund, Sweden, SE-221 85
Skåne University Hospital, UMAS
Malmö, Sweden, SE-205 02
Sachsska, Södersjukhuset
Stockholm, Sweden, SE-118 83
Astrid Lindgren Children's Hospital
Stockholm, Sweden, SE-171 76
Uddevalla Hospital
Uddevalla, Sweden, SE-451 80
Örebro University Hospital
Örebro, Sweden, SE-701 85
Sponsors and Collaborators
Johnny Ludvigsson
Swedish Child Diabetes Foundation
The Research Council of South East Sweden (FORSS)
Diamyd Medical AB
Investigators
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Principal Investigator: Johnny Ludvigsson, MD,PhD,Prof Linkoeping University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Johnny Ludvigsson, MD, PhD, Professor, Linkoeping University
ClinicalTrials.gov Identifier: NCT01785108     History of Changes
Other Study ID Numbers: DIABGAD-1
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017
Keywords provided by Johnny Ludvigsson, Linkoeping University:
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
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Vitamin D
Ergocalciferols
Vitamins
Insulin
Ibuprofen
Aluminum sulfate
Hypoglycemic Agents
Physiological Effects of Drugs
 Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action