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Diabetes Prevention - Immune Tolerance

2014-08-27 03:13:45 | BioPortfolio

Summary

A double-blind, randomized investigator-initiated study to determine the safety and the effect of Diamyd® on the progression to type 1 diabetes in children with multiple islet cell autoantibodies

Eligible children are 4 years or older, have positive GAD-antibodies and at leas one additional autoantibody and not yet diabetes.

Objectives

DiAPREV-IT is the first prevention study with Diamyd®, where the drug is given before onset of type 1 diabetes.

The primary objective is to demonstrate that Diamyd® is safe in children at risk for type 1 diabetes.

The secondary objective is to evaluate if Diamyd® may delay or stop the autoimmune process leading to clinical type 1 diabetes in children with ongoing persistent beta-cell autoimmunity as indicated by multiple positive islet cell autoantibodies.

Procedure:

50 children will be randomized to 2 injections of Diamyd® or placebo. In DIAPREV-IT we will use the previously tested dose of 20 µg Diamyd® administered as a prime-and-boost at days 1 and 30, as no serious adverse reactions have been observed with this regimen. The children will be followed every 3rd month for 5 years. Before the first injection of study drug both intravenous (IvGTT) and oral (OGTT)glucose tolerance test will be performed. These will be repeated during the study with OGTT every 6 month visit and IvGTT every full year visit.

Effect variables

The proportion of subjects in the two treatment groups who develop type 1 diabetes after 1, 2, 3, 4 and 5 years.

Change in first-phase insulin response on IvGTT from baseline Fasting and 2 hours C-peptide levels on OGTT Two hour glucose value after OGTT Change in HbA1c from baseline

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Conditions

Prediabetes

Intervention

Diamyd®

Location

Clinical Research Center, Pediatric Endocrinology, Ing 72, hus 91, plan 10
Malmö
Sweden
205 02

Status

Recruiting

Source

Lund University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:45-0400

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