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Efficacy and Safety of Diamyd® in Children and Adolescents With Type 1 Diabetes

NCT ID: NCT00435981

Last Updated: 2008-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-12-31

Brief Summary

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This is a randomized, placebo-controlled phase II study to investigate if a prime and boost of 20ug Diamyd® (rhGAD65 formulated in Alhydrogel®), administered subcutaneously four weeks apart, is safe and can preserve beta cell function in children and adolescents with type 1 diabetes with a diabetes duration less than 18 months at intervention.

Detailed Description

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Conditions

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Type 1 Diabetes

Keywords

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Type 1 diabetes GAD65 Autoimmunity C-peptide Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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rhGAD65 formulated in Alhydrogel® (Diamyd®)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female patients between 10 and 18 years of age, diagnosed with type 1 diabetes within 18 months
* Fasting C-peptide level above 0.1 nmol/l
* Presence of GAD65 antibodies
* Written informed consent (patient and parent/guardian)

Exclusion Criteria

* Secondary diabetes mellitus or MODY
* Treatment with immunosuppressants
* Treatment with any vaccine within 1 month prior to first Diamyd® dose or planned treatment with vaccine up to 2 months after the second Diamyd® dose
* Participation in other clinical trials with a new chemical entity within the previous 3 months
* History of certain diseases or conditions (e.g. epilepsy, anaemia, alcohole or drug abuse)
* HIV or hepatitis
* Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study
* Pregnancy (or planned pregnancy within one year after 2nd administration)
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diamyd Therapeutics AB

INDUSTRY

Sponsor Role lead

Principal Investigators

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Johnny Ludvigsson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Div of Pediatrics, Dept of Clinical and Molecular Medicine, Faculty of Health Sciences, Linkoping University, Sweden

Locations

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Borås Hospital

Borås, , Sweden

Site Status

The Queen Silvia Children´s Hospital

Gothenburg, , Sweden

Site Status

Halmstad Hospital

Halmstad, , Sweden

Site Status

Ryhov Hospital

Jönköping, , Sweden

Site Status

Linköping University

Linköping, , Sweden

Site Status

University Hospital, MAS

Malmo, , Sweden

Site Status

Örebro University Hospital

Örebro, , Sweden

Site Status

Astrid Lindgren Children´s Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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Ludvigsson J, Cheramy M, Axelsson S, Pihl M, Akerman L, Casas R; Clinical GAD-Study Group in Sweden. GAD-treatment of children and adolescents with recent-onset type 1 diabetes preserves residual insulin secretion after 30 months. Diabetes Metab Res Rev. 2014 Jul;30(5):405-14. doi: 10.1002/dmrr.2503.

Reference Type DERIVED
PMID: 24302596 (View on PubMed)

Ludvigsson J, Hjorth M, Cheramy M, Axelsson S, Pihl M, Forsander G, Nilsson NO, Samuelsson BO, Wood T, Aman J, Ortqvist E, Casas R. Extended evaluation of the safety and efficacy of GAD treatment of children and adolescents with recent-onset type 1 diabetes: a randomised controlled trial. Diabetologia. 2011 Mar;54(3):634-40. doi: 10.1007/s00125-010-1988-1. Epub 2010 Nov 30.

Reference Type DERIVED
PMID: 21116604 (View on PubMed)

Ludvigsson J, Faresjo M, Hjorth M, Axelsson S, Cheramy M, Pihl M, Vaarala O, Forsander G, Ivarsson S, Johansson C, Lindh A, Nilsson NO, Aman J, Ortqvist E, Zerhouni P, Casas R. GAD treatment and insulin secretion in recent-onset type 1 diabetes. N Engl J Med. 2008 Oct 30;359(18):1909-20. doi: 10.1056/NEJMoa0804328. Epub 2008 Oct 8.

Reference Type DERIVED
PMID: 18843118 (View on PubMed)

Other Identifiers

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EUDRACT 2004-003764-30

Identifier Type: -

Identifier Source: secondary_id

D/P2/04/3

Identifier Type: -

Identifier Source: org_study_id