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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2011 by Oslo University Hospital
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01129232
First received: May 11, 2010
Last updated: May 3, 2011
Last verified: April 2011

May 11, 2010
May 3, 2011
January 2011
January 2016   (final data collection date for primary outcome measure)
  • Intensity of insulitis in proportion to living, insulin-staining beta cells in pancreatic biopsies [ Time Frame: 18 months after inclusion ] [ Designated as safety issue: No ]
  • Prevalence of virus infected islets in pancreatic biopsies [ Time Frame: 18 months after inclusion ] [ Designated as safety issue: No ]
  • Intensity of insulitis in proportion to living, insulin-staining beta cells in pancreatic biopsies [ Time Frame: 2 weeks after inclusion ] [ Designated as safety issue: No ]
  • Prevalence of virus infected islets in pancreatic biopsies [ Time Frame: 2 weeks after inclusion ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01129232 on ClinicalTrials.gov Archive Site
  • Residual insulin secretion (C-peptide) measured by Mixed Meal Tolerance Test [ Time Frame: 36 months after diagnosis ] [ Designated as safety issue: No ]
    Will be measured at 0, 1, 3, 9, 18, 24 and 36 months after diagnosis, but time frame is at 36 months
  • Insulin dosage/kilo bodyweight/24 hours [ Time Frame: 36 months after diagnosis ] [ Designated as safety issue: No ]
    Will be calculated at 0, 1, 3, 9, 18, 24 and 36 months after diagnosis, but time frame is 36 months after diagnosis
  • Glycosylated hemoglobin A1 (HbA1c) [ Time Frame: 36 months after diagnosis ] [ Designated as safety issue: No ]
    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
Same as current
Not Provided
Not Provided
 
Diabetes Virus Detection Project, Intervention With GAD-alum
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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Diabetes, Type I
  • Enterovirus Infections
  • Autoimmunity
  • Drug: GAD-alum
    20 µg of GAD-alum injected sc after the biopsy, and repeated after one month
    Other Name: Diamyd
  • Other: Placebo
    Placebo injected after the biopsy and repeated after one month (similar to the GAD-alum-arm)
    Other Name: Placebo
  • Experimental: GAD-alum
    GAD-alum administered at 0 and 1 months after inclusion
    Intervention: Drug: GAD-alum
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
January 2016
January 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
No
Contact: Lars Krogvold, MD +47 97522277 lars.krogvold@medisin.uio.no
Contact: Knut Dahl-Jørgensen, Prof +47 22119090 knut.dahl-jorgensen@medisin.uio.no
Norway
 
NCT01129232
2009/1907 (REK), 2008-002027-82
Yes
Knut Dahl-Jørgensen, professor, Oslo University Hospital
Oslo University Hospital
Not Provided
Principal Investigator: Knut Dahl-Jorgensen, Prof Oslo University Hospital
Oslo University Hospital
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP