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

February 15, 2007
January 29, 2008
January 2005
October 2007   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT00435981 on ClinicalTrials.gov Archive Site
To evaluate the safety of Diamyd® 20ug.
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Diamyd® in Children and Adolescents With Type 1 Diabetes
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Type 1 Diabetes
Drug: rhGAD65 formulated in Alhydrogel® (Diamyd®)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
December 2007
October 2007   (final data collection date for primary outcome measure)

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)
Both
10 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00435981
D/P2/04/3, EUDRACT 2004-003764-30
Not Provided
Not Provided
Diamyd Therapeutics AB
Not Provided
Principal Investigator: Johnny Ludvigsson, MD, PhD Div of Pediatrics, Dept of Clinical and Molecular Medicine, Faculty of Health Sciences, Linkoping University, Sweden
Diamyd Therapeutics AB
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP