We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00435981
First Posted: February 16, 2007
Last Update Posted: January 30, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Diamyd Therapeutics AB
  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
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:


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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):
ClinicalTrials.gov Identifier: NCT00435981     History of Changes
Other Study ID Numbers: D/P2/04/3
EUDRACT 2004-003764-30
First Submitted: February 15, 2007
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