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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Linkoeping University
Sponsor:
Collaborators:
The Swedish Child Diabetes Foundation (Barndiabetesfonden)
The Research Council of South East Sweden (FORSS)
ALF
Diamyd Therapeutics AB (unrestricted grant)
Information provided by (Responsible Party):
Johnny Ludvigsson, Linkoeping University
ClinicalTrials.gov Identifier:
NCT01785108
First received: February 1, 2013
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Linkoeping University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with a stimulated maximum C-peptide level above 0.2 nmol/L [ Time Frame: 6, 15 and 30 months ] [ Designated as safety issue: No ]
  • Hemoglobin A1c (HbA1c), change between baseline and subsequent visits [ Time Frame: 6, 15 and 30 months ] [ Designated as safety issue: No ]
  • Exogenous insulin dose per kg body weight and 24 hours, change between baseline and subsequent visits [ Time Frame: 6, 15 and 30 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Decrease in inflammatory markers, e.g. TNF-alfa, IL-1 beta, IL-2, IL-17 [ Time Frame: 6, 15 and 30 months ] [ Designated as safety issue: No ]
  • Fasting C-peptide, change between baseline and month 6, 15 and 30 [ Time Frame: 6, 15 and 30 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01785108

Contacts
Contact: Johnny Ludvigsson johnny.ludvigsson@liu.se
Contact: Rosaura Casas rosaura.casas@liu.se

Locations
Sweden
Halmstad Hospital Recruiting
Halmstad, Sweden, SE-301 85
Principal Investigator: Torben Ek         
Astrid Lindgren Children's Hospital - Huddinge Recruiting
Huddinge, Sweden, SE-141 86
Principal Investigator: Torun Torbjornsdotter, MD         
Kalmar Hospital Not yet recruiting
Kalmar, Sweden, SE-391 85
Principal Investigator: Göran Lundström, MD         
Linköping University Recruiting
Linköping, Sweden, SE-581 85
Principal Investigator: Johnny Ludvigsson, MD         
Lund University Hospital Recruiting
Lund, Sweden, SE-221 85
Principal Investigator: Annelie Carlsson, MD         
Skåne University Hospital, UMAS Recruiting
Malmö, Sweden, SE-205 02
Principal Investigator: Helena Larsson, MD         
Astrid Lindgren Children's Hospital Recruiting
Stockholm, Sweden, SE-171 76
Principal Investigator: Eva Örtqvist, MD         
Sachsska, Södersjukhuset Recruiting
Stockholm, Sweden, SE-118 83
Principal Investigator: Björn Rathsman, MD         
Uddevalla Hospital Recruiting
Uddevalla, Sweden, SE-451 80
Principal Investigator: Ragnar Hanås, MD         
Örebro University Hospital Recruiting
Örebro, Sweden, SE-701 85
Principal Investigator: Jan Åman, MD         
Sponsors and Collaborators
Johnny Ludvigsson
The Swedish Child Diabetes Foundation (Barndiabetesfonden)
The Research Council of South East Sweden (FORSS)
ALF
Diamyd Therapeutics AB (unrestricted grant)
Investigators
Principal Investigator: Johnny Ludvigsson, MD,PhD,Prof Linköping University
  More Information

No publications provided

Responsible Party: Johnny Ludvigsson, MD, PhD, Professor, Linkoeping University
ClinicalTrials.gov Identifier: NCT01785108     History of Changes
Other Study ID Numbers: DIABGAD-1
Study First Received: February 1, 2013
Last Updated: September 24, 2013
Health Authority: Sweden: Medical Products Agency

Keywords provided by Linkoeping University:
Juvenile Diabetes
Diabetes type 1
Insulin dependent Diabetes
Type 1 diabetes
Type 1 diabetes mellitus
Diabetes Mellitus, Type 1
Diamyd
Diabetes
Autoimmune Diabetes
rhGAD65
GAD
GAD65
GAD-alum
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Vitamin D
Ibuprofen

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Vitamin D
Ergocalciferols
Vitamins
Insulin
Ibuprofen
Aluminum sulfate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances
Hypoglycemic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014