CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
GAD-Alum +2 moredrug
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.

Search/NCT02464033
NCT02464033Phase 2Completed
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Open Label Trial to Evaluate the Tolerability of a Combination Therapy Consisting of GAD-alum (Diamyd®), Etanercept and Vitamin D in Children and Adolescents Newly Diagnosed With Type 1 Diabetes

Johnny Ludvigsson·interventional·Posted Jun 8, 2015·Updated Mar 29, 2021

In Brief

A Phase 2 clinical trial evaluating GAD-Alum, Vitamin D, and 1 other intervention for Diabetes Mellitus, Type 1. Completed, enrolled 20 participants across 8 sites.

Detailed Summary

The objectives of this study is to: * Evaluate the tolerability of a combination therapy with Diamyd, vitamin D and etanercept * Evaluate how the above mentioned treatments influence the immune system and endogenous insulin secretion

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 1
CountriesSweden
CollaboratorsSwedish Child Diabetes Foundation, Ostergotland County Council, Sweden, Diamyd Medical AB

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 8, 2015
Enrollment StartMay 1, 2015
Primary CompletionFeb 25, 2019
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 11.1 years ago

Interventions

GAD-Alumdrug

Recombinant Human Glutamic Acid Decarboxylase (rhGAD65)

Vitamin Ddrug

Etanerceptdrug