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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00435981

Enrollment

Registered

2007-02-16

Start date

2005-01-31

Completion date

2007-12-31

Last updated

2008-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetes, GAD65, Autoimmunity, C-peptide, Children

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.

Interventions

DRUGrhGAD65 formulated in Alhydrogel® (Diamyd®)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

10 Years to 18 Years

Healthy volunteers

Inclusion 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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
To evaluate the safety of Diamyd® 20ug.	—

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026