At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 109 enrolled
Drug / intervention
Diamyd +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IIb, 2-Arm, Randomized, Double-blind, Placebo-Controlled, Multicentre Study to Optimize Diamyd Therapy Administered Into Lymph Nodes Combined With Oral Vitamin D to Investigate the Impact on the Progression of Type 1 Diabetes
In Brief
A Phase 2 clinical trial evaluating Diamyd, Vitamin D, and 2 other interventions for Diabetes Mellitus, Type 1 and 11 related conditions. Completed, enrolled 109 participants across 18 sites in 4 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes 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
CountriesCzechia, Netherlands, Spain, Sweden
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedNov 2017
Enrollment StartDec 2017
Primary CompletionJul 2020
Study CompletionApr 2021
TodayJul 2026
First PostedNov 17, 2017
Enrollment StartDec 20, 2017
Primary CompletionJul 13, 2020
Study CompletionApr 27, 2021
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 8.6 years ago
Interventions
Diamydbiological
Alhydrogel®-formulated recombinant human glutamic acid decarboxylase (rhGAD65)
Vitamin Ddietary
Oil suspension of Vitamin D
Placebo for Diamydbiological
Alhydrogel® only
Placebo for Vitamin Ddietary
Placebo oil suspension for Vitamin D