Trials / Completed
CompletedNCT00435981
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
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (planned)
- Sponsor
- Diamyd Therapeutics AB · Industry
- Sex
- All
- Age
- 10 Years – 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | rhGAD65 formulated in Alhydrogel® (Diamyd®) |
Timeline
- Start date
- 2005-01-01
- Primary completion
- 2007-10-01
- Completion
- 2007-12-01
- First posted
- 2007-02-16
- Last updated
- 2008-01-30
Locations
8 sites across 1 country: Sweden
Source: ClinicalTrials.gov record NCT00435981. Inclusion in this directory is not an endorsement.