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

• ClinicalTrials.gov Identifier: NCT00435981
• Recruitment Status: Completed
• First Posted: February 16, 2007
• Last Update Posted: January 30, 2008
• Sponsor: Diamyd Therapeutics AB
• Information provided by: Diamyd Therapeutics AB

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Type 1 Diabetes	Drug: rhGAD65 formulated in Alhydrogel® (Diamyd®)	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• 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
• Study Start Date: January 2005
• Actual Primary Completion Date: October 2007
• Actual Study Completion Date: December 2007

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. To evaluate the safety of Diamyd® 20ug.

Eligibility Criteria

• 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

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, 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.

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.

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.

• ClinicalTrials.gov Identifier: NCT00435981
• Other Study ID Numbers: D/P2/04/3; EUDRACT 2004-003764-30
• First Posted: February 16, 2007
• Last Update Posted: January 30, 2008
• Last Verified: January 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