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

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 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Type 1

Drug Information available for: 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 (Child, Adult)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ludvigsson J, Chéramy 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.

Ludvigsson J, Hjorth M, Chéramy M, Axelsson S, Pihl M, Forsander G, Nilsson NÖ, 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.

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. doi: 10.1056/NEJMoa0804328. Epub 2008 Oct 8.


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

Keywords provided by Diamyd Therapeutics AB:


Type 1 diabetes GAD65 Autoimmunity C-peptide Children

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases	Aluminum Hydroxide Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Antacids Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 17, 2017