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

This study has been completed.
Sponsor:
Information provided by:
Diamyd Therapeutics AB
ClinicalTrials.gov Identifier:
NCT00435981
First received: February 15, 2007
Last updated: January 29, 2008
Last verified: January 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
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:

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
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
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

No publications provided by Diamyd Therapeutics AB

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

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
Health Authority: Sweden: Medical Products Agency

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
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013