Diabetes Virus Detection Project, Intervention With GAD-alum (DiViD)

May 14, 2018 updated by: Lars Krogvold, Oslo University Hospital

A Phase II-study (Therapeutic Exploratory) of GAD-alum in Newly Diagnosed Type-1 Diabetic Patients, With Focus One the Presence of Viruses at the Time of Diagnosis

The purposes of this study are to test whether GAD vaccination can stop the progression of newly diagnosed type 1 diabetes, to describe the related immunological processes (insulitis) in pancreas and small intestines evolving the mechanism of the effect of GAD vaccination and finally try to detect viruses and virus receptors directly in the insulin producing beta cells of the pancreas in patients with newly diagnosed type-1 diabetes mellitus (T1D).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The aetiology of type 1 diabetes is unknown. Both genetic and environmental factors seem to be important for the destruction of insulin producing beta cells in the pancreas. Increasing indirect evidences exist that picornaviruses may either directly or indirectly through autoimmune processes destroy beta cells. New sensitive assays have been developed to detect these viruses and to study the immunological processes, especially T-cell function. Microsurgical technology has been refined, now making pancreatic biopsies a safe procedure. This study focuses on advanced in depth studies of immunology and virology in pancreatic tissue and small intestine at an early stage of disease.

Study Type

Interventional

Enrollment (Actual)

6

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

  • Norway
      • Oslo, Norway, 0514
        • Endokrinologisk poliklinikk, Oslo Universitetssykehus Aker

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Newly diagnosed classical type-1 diabetes
  • Positive GAD antibodies
  • Fasting C-peptide >0.1 mmol/l
  • Insulin dosage >0.1 U/kg Bodyweight/day

Exclusion Criteria:

  • Pregnancy
  • Weaning
  • Other chronic diseases than diabetes
  • Any regular medication except oral contraceptives
  • Psychiatric disturbances

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
Other: Placebo
Placebo injected after the biopsy and repeated after one month (similar to the GAD-alum-arm)
Experimental: GAD-alum
GAD-alum administered at 0 and 1 months after inclusion
Drug: GAD-alum
20 µg of GAD-alum injected sc after the biopsy, and repeated after one month
Other Names:
  • Diamyd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intensity of insulitis in proportion to living, insulin-staining beta cells in pancreatic biopsies
Time Frame: 18 months after inclusion
18 months after inclusion
Prevalence of virus infected islets in pancreatic biopsies
Time Frame: 18 months after inclusion
18 months after inclusion
Intensity of insulitis in proportion to living, insulin-staining beta cells in pancreatic biopsies
Time Frame: 2 weeks after inclusion
2 weeks after inclusion
Prevalence of virus infected islets in pancreatic biopsies
Time Frame: 2 weeks after inclusion
2 weeks after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Residual insulin secretion (C-peptide) measured by Mixed Meal Tolerance Test
Time Frame: 36 months after diagnosis
Will be measured at 0, 1, 3, 9, 18, 24 and 36 months after diagnosis, but time frame is at 36 months
36 months after diagnosis
Insulin dosage/kilo bodyweight/24 hours
Time Frame: 36 months after diagnosis
Will be calculated at 0, 1, 3, 9, 18, 24 and 36 months after diagnosis, but time frame is 36 months after diagnosis
36 months after diagnosis
Glycosylated hemoglobin A1 (HbA1c)
Time Frame: 36 months after diagnosis
Will be measrured at 0, 1, 3, 9, 18, 24 and 36 months after diagnosis, but time frame is at 36 months. To investigate wether an eventual better endogenous insulin production gives better metabolic control, estimated by lower HbAic
36 months after diagnosis

Collaborators and Investigators

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

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Knut Dahl-Jorgensen, Prof, Oslo University Hospital

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

January 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

May 11, 2010

First Submitted That Met QC Criteria

May 21, 2010

First Posted (Estimate)

May 24, 2010

Study Record Updates

Last Update Posted (Actual)

May 17, 2018

Last Update Submitted That Met QC Criteria

May 14, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/1907 (REK)
  • 2008-002027-82 (EudraCT Number)

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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