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

August 22, 2017 updated by: Johnny Ludvigsson

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Halmstad, Sweden, SE-301 85
        • Halmstad Hospital
      • Huddinge, Sweden, SE-141 86
        • Astrid Lindgren Children's Hospital - Huddinge
      • Kalmar, Sweden, SE-391 85
        • Kalmar Hospital
      • Linköping, Sweden, SE-581 85
        • Linkoping University
      • Lund, Sweden, SE-221 85
        • Lund University Hospital
      • Malmö, Sweden, SE-205 02
        • Skåne University Hospital, UMAS
      • Stockholm, Sweden, SE-118 83
        • Sachsska, Södersjukhuset
      • Stockholm, Sweden, SE-171 76
        • Astrid Lindgren Children's Hospital
      • Uddevalla, Sweden, SE-451 80
        • Uddevalla Hospital
      • Örebro, Sweden, SE-701 85
        • Örebro University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Vitamin D
Drug: Ibuprofen
Biological: GAD-Alum (Diamyd) 20 µg X 2
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
Drug: Vitamin D
Drug: Ibuprofen
Biological: GAD-Alum (Diamyd) 20 µg
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
Drug: Vitamin D
Biological: GAD-Alum (Diamyd) 20 µg
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
Drug: Vitamin D
Biological: GAD-Alum (Diamyd) 20 µg X 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months, 15 months and 30 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnny Ludvigsson

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

February 1, 2013

First Submitted That Met QC Criteria

February 4, 2013

First Posted (Estimate)

February 7, 2013

Study Record Updates

Last Update Posted (Actual)

August 23, 2017

Last Update Submitted That Met QC Criteria

August 22, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIABGAD-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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