Diabetes Virus Detection Project, Intervention With GAD-alum

NCT01129232 | Terminated Phase 2 DMC

• 2 other identifiers: 2009/1907 (REK)2008-002027-82
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Diabetes, Type I; Enterovirus Infections; Autoimmunity

Keywords

insulin

Outcome Measures

Primary Outcomes (4)

• Intensity of insulitis in proportion to living, insulin-staining beta cells in pancreatic biopsies

  18 months after inclusion

• Prevalence of virus infected islets in pancreatic biopsies

  18 months after inclusion

• Intensity of insulitis in proportion to living, insulin-staining beta cells in pancreatic biopsies

  2 weeks after inclusion

• Prevalence of virus infected islets in pancreatic biopsies

  2 weeks after inclusion

Secondary Outcomes (3)

• Residual insulin secretion (C-peptide) measured by Mixed Meal Tolerance Test

  36 months after diagnosis

• Insulin dosage/kilo bodyweight/24 hours

  36 months after diagnosis

• Glycosylated hemoglobin A1 (HbA1c)

  36 months after diagnosis

Study Arms (2)

GAD-alum

EXPERIMENTAL

GAD-alum administered at 0 and 1 months after inclusion

Drug: GAD-alum

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

GAD-alum DRUG

20 µg of GAD-alum injected sc after the biopsy, and repeated after one month

Also known as: Diamyd

GAD-alum

Placebo OTHER

Placebo injected after the biopsy and repeated after one month (similar to the GAD-alum-arm)

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Endokrinologisk poliklinikk, Oslo Universitetssykehus Aker

Oslo, 0514, Norway

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Enterovirus Infections; Autoimmune Diseases; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Immune System Diseases; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Hyperinsulinism

Study Officials

• Knut Dahl-Jorgensen, Prof

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assosciate professor

Study Record Dates

• First Submitted: May 11, 2010
• First Posted: May 24, 2010
• Study Start: January 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: May 17, 2018

Record last verified: 2018-05

Locations

NO (1)