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Diamyd Administered Into Lymph Nodes in Combination With Vitamin D in Type 1 Diabetes

NCT03345004 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2023-01-09

Study results available
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Summary

The objective of DIAGNODE-2 is to evaluate the efficacy of Diamyd compared to Placebo, upon administration directly into a lymph node in combination with an oral vitamin D/Placebo regimen, in terms of preserving endogenous insulin secretion as measured by C-peptide.

Conditions

  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus
  • Autoimmune Diseases
  • Metabolic Disease
  • Glucose Metabolism Disorders
  • Immune System Diseases
  • Endocrine System Diseases
  • Juvenile Diabetes
  • Insulin Dependent Diabetes
  • Autoimmune Diabetes
  • Vitamin D
  • Physiological Effects of Drugs

Interventions

BIOLOGICAL

Diamyd

Alhydrogel®-formulated recombinant human glutamic acid decarboxylase (rhGAD65)

DIETARY_SUPPLEMENT

Vitamin D

Oil suspension of Vitamin D

BIOLOGICAL

Placebo for Diamyd

Alhydrogel® only

DIETARY_SUPPLEMENT

Placebo for Vitamin D

Placebo oil suspension for Vitamin D

Sponsors & Collaborators

  • Diamyd Medical AB

    lead INDUSTRY

Principal Investigators

  • Johnny Ludvigsson, MD, Prof · Universitetssjukhuset i Linköping

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-20
Primary Completion
2020-07-13
Completion
2021-04-27

Countries

  • Czechia
  • Netherlands
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03345004 on ClinicalTrials.gov