This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
Diamyd Therapeutics AB Identifier:
First received: February 15, 2007
Last updated: January 29, 2008
Last verified: January 2008
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)

Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00435981

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
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 Identifier (NCT Number): 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

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
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents processed this record on September 19, 2017