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

Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00435981
• Other study ID #: D/P2/04/3
• Secondary ID: EUDRACT 2004-003
• Status: Completed
• Phase: Phase 2
• First received: February 15, 2007
• Last updated: January 29, 2008
• Start date: January 2005
• Est. completion date: December 2007

Study information

• Verified date: January 2008
• Source: Diamyd Therapeutics AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• rhGAD65 formulated in Alhydrogel® (Diamyd®)

Locations

Country	Name	City	State
Sweden	Borås Hospital	Borås
Sweden	The Queen Silvia Children´s Hospital	Göteborg
Sweden	Halmstad Hospital	Halmstad
Sweden	Ryhov Hospital	Jönköping
Sweden	Linköping University	Linköping
Sweden	University Hospital, MAS	Malmö
Sweden	Örebro University Hospital	Örebro
Sweden	Astrid Lindgren Children´s Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Diamyd Therapeutics AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To evaluate the safety of Diamyd® 20ug.