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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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
GAD-Alum (Diamyd) 20 µg
GAD-Alum (Diamyd) 20 µg X 2
Vitamin D
Ibuprofen
Sponsored by
Johnny Ludvigsson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring 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

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Halmstad Hospital
  • Astrid Lindgren Children's Hospital - Huddinge
  • Kalmar Hospital
  • Linköping University
  • Lund University Hospital
  • Skåne University Hospital, UMAS
  • Sachsska, Södersjukhuset
  • Astrid Lindgren Children's Hospital
  • Uddevalla Hospital
  • Örebro University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

GAD-Alum (Diamyd) 20µg, Vitamin D and Ibuprofen

GAD-Alum (Diamyd) 20µg and Vitamin D

GAD-Alum (Diamyd) 20 µg x 2 and Vitamin D

Placebo

Arm Description

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

GAD-Alum (Diamyd) 20 µg given twice with one month interval Vitamin D oral drops, 2000 IU/day, from Day 1 to Day 450

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

Outcomes

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

Secondary Outcome Measures

Proportion of patients with a stimulated maximum C-peptide level above 0.2 nmol/L
Hemoglobin A1c (HbA1c), change between baseline and subsequent visits
Exogenous insulin dose per kg body weight and 24 hours, change between baseline and subsequent visits
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
Decrease in inflammatory markers, e.g. TNF-alfa, IL-1 beta, IL-2, IL-17
Fasting C-peptide, change between baseline and month 6, 15 and 30

Full Information

First Posted
February 1, 2013
Last Updated
August 22, 2017
Sponsor
Johnny Ludvigsson
Collaborators
Swedish Child Diabetes Foundation, The Research Council of South East Sweden (FORSS), Diamyd Medical AB
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1. Study Identification

Unique Protocol Identification Number
NCT01785108
Brief Title
DIABGAD - Trial to Preserve Insulin Secretion in Type 1 Diabetes Using GAD-Alum (Diamyd) in Combination With Vitamin D and Ibuprofen
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 Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Johnny Ludvigsson
Collaborators
Swedish Child Diabetes Foundation, The Research Council of South East Sweden (FORSS), Diamyd Medical AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GAD-Alum (Diamyd) 20µg, Vitamin D and Ibuprofen
Arm Type
Active Comparator
Arm Description
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
Arm Title
GAD-Alum (Diamyd) 20µg and Vitamin D
Arm Type
Active Comparator
Arm Description
GAD-Alum (Diamyd) 20 µg given twice with one month interval Vitamin D oral drops, 2000 IU/day, from Day 1 to Day 450
Arm Title
GAD-Alum (Diamyd) 20 µg x 2 and Vitamin D
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
GAD-Alum (Diamyd) 20 µg
Intervention Type
Biological
Intervention Name(s)
GAD-Alum (Diamyd) 20 µg X 2
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Proportion of patients with a stimulated maximum C-peptide level above 0.2 nmol/L
Time Frame
6, 15 and 30 months
Title
Hemoglobin A1c (HbA1c), change between baseline and subsequent visits
Time Frame
6, 15 and 30 months
Title
Exogenous insulin dose per kg body weight and 24 hours, change between baseline and subsequent visits
Time Frame
6, 15 and 30 months
Title
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
Title
Decrease in inflammatory markers, e.g. TNF-alfa, IL-1 beta, IL-2, IL-17
Time Frame
6, 15 and 30 months
Title
Fasting C-peptide, change between baseline and month 6, 15 and 30
Time Frame
6, 15 and 30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnny Ludvigsson, MD,PhD,Prof
Organizational Affiliation
Linkoeping University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Halmstad Hospital
City
Halmstad
ZIP/Postal Code
SE-301 85
Country
Sweden
Facility Name
Astrid Lindgren Children's Hospital - Huddinge
City
Huddinge
ZIP/Postal Code
SE-141 86
Country
Sweden
Facility Name
Kalmar Hospital
City
Kalmar
ZIP/Postal Code
SE-391 85
Country
Sweden
Facility Name
Linköping University
City
Linköping
ZIP/Postal Code
SE-581 85
Country
Sweden
Facility Name
Lund University Hospital
City
Lund
ZIP/Postal Code
SE-221 85
Country
Sweden
Facility Name
Skåne University Hospital, UMAS
City
Malmö
ZIP/Postal Code
SE-205 02
Country
Sweden
Facility Name
Sachsska, Södersjukhuset
City
Stockholm
ZIP/Postal Code
SE-118 83
Country
Sweden
Facility Name
Astrid Lindgren Children's Hospital
City
Stockholm
ZIP/Postal Code
SE-171 76
Country
Sweden
Facility Name
Uddevalla Hospital
City
Uddevalla
ZIP/Postal Code
SE-451 80
Country
Sweden
Facility Name
Örebro University Hospital
City
Örebro
ZIP/Postal Code
SE-701 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
32802401
Citation
Ludvigsson J, Routray I, Elluru S, Leanderson P, Larsson HE, Rathsman B, Hanas R, Carlsson A, Ek T, Samuelsson U, Torbjornsdotter T, Aman J, Ortqvist E, Badwal K, Beam C, Casas R. Combined vitamin D, ibuprofen and glutamic acid decarboxylase-alum treatment in recent onset Type I diabetes: lessons from the DIABGAD randomized pilot trial. Future Sci OA. 2020 Jun 23;6(7):FSO604. doi: 10.2144/fsoa-2020-0078.
Results Reference
derived
PubMed Identifier
30009185
Citation
Tavira B, Barcenilla H, Wahlberg J, Achenbach P, Ludvigsson J, Casas R. Intralymphatic Glutamic Acid Decarboxylase-Alum Administration Induced Th2-Like-Specific Immunomodulation in Responder Patients: A Pilot Clinical Trial in Type 1 Diabetes. J Diabetes Res. 2018 May 24;2018:9391845. doi: 10.1155/2018/9391845. eCollection 2018.
Results Reference
derived

Learn more about this trial

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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