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

Phase 2

Completed

• Conditions: Type 1 Diabetes

• Registration Number: NCT00435981
• Lead Sponsor: Diamyd Therapeutics AB

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2007-02-15
• Study First Submitted QC: 2007-02-15
• Study First Posted: 2007-02-16
• Primary Completion: 2007-10
• Study Completion: 2007-12
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-29
• Last Update Posted: 2008-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To evaluate the safety of Diamyd® 20ug.

Trial Locations

Locations (8)

Ryhov Hospital; 🇸🇪 Jönköping, Sweden

Linköping University; 🇸🇪 Linköping, Sweden

Borås Hospital; 🇸🇪 Borås, Sweden

The Queen Silvia Children´s Hospital; 🇸🇪 Göteborg, Sweden

Halmstad Hospital; 🇸🇪 Halmstad, Sweden

Örebro University Hospital; 🇸🇪 Örebro, Sweden

University Hospital, MAS; 🇸🇪 Malmö, Sweden

Astrid Lindgren Children´s Hospital; 🇸🇪 Stockholm, Sweden