Efficacy and Safety of Diamyd® in Children and Adolescents With Type 1 Diabetes - Full Text View

Sponsor:	Diamyd Therapeutics AB
Information provided by:	Diamyd Therapeutics AB
ClinicalTrials.gov Identifier:	NCT00435981

Purpose

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.

Condition	Intervention	Phase
Type 1 Diabetes	Drug: rhGAD65 formulated in Alhydrogel® (Diamyd®)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II, Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Study to Investigate the Impact of Diamyd® on the Progression of Diabetes in Patients Newly Diagnosed With Type 1 Diabetes Mellitus

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Aluminum hydroxide Algeldrate

U.S. FDA Resources

Further study details as provided by Diamyd Therapeutics AB:

Primary Outcome Measures:

To evaluate the efficacy of Diamyd® 20ug versus placebo with respect to preserving residual insulin secretion as measured by C-peptide levels. The effect of intervention will be evaluated at month 15 (main study period) and at month 30 (Extension phase).

Secondary Outcome Measures:

To evaluate the safety of Diamyd® 20ug.

Estimated Enrollment:	70
Study Start Date:	January 2005
Study Completion Date:	December 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	10 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key 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)

Key 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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435981

Locations

Sweden
Ryhov Hospital
Jönköping, Sweden, SE-551 85
Örebro University Hospital
Örebro, Sweden, SE-701 85
University Hospital, MAS
Malmö, Sweden, SE-205 02
The Queen Silvia Children´s Hospital
Göteborg, Sweden, SE-416 85
Linköping University
Linköping, Sweden, SE-581 85
Halmstad Hospital
Halmstad, Sweden, SE-301 85
Borås Hospital
Borås, Sweden, SE-501 82
Astrid Lindgren Children´s Hospital
Stockholm, Sweden, SE-171 76

Sponsors and Collaborators

Diamyd Therapeutics AB

Investigators

Principal Investigator:

Johnny Ludvigsson, MD, PhD

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

More Information

No publications provided by Diamyd Therapeutics AB

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Ludvigsson J, Faresjö M, Hjorth M, Axelsson S, Chéramy 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. Epub 2008 Oct 8.

Study ID Numbers:	D/P2/04/3, EUDRACT 2004-003764-30
Study First Received:	February 15, 2007
Last Updated:	January 29, 2008
ClinicalTrials.gov Identifier:	NCT00435981 History of Changes
Health Authority:	Sweden: Medical Products Agency

Keywords provided by Diamyd Therapeutics AB:

Type 1 diabetes
GAD65
Autoimmunity
C-peptide
Children

Additional relevant MeSH terms:

Metabolic Diseases
Autoimmune Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Diabetes Mellitus

Adjuvants, Immunologic
Endocrine System Diseases
Pharmacologic Actions
Aluminum Hydroxide
Diabetes Mellitus, Type 1
Antacids
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 30, 2009