Trials / Completed
CompletedNCT02464033
EDCR Study - Etanercept Diamyd Combination Regimen -Open Trial to Evaluate Safety in Children With Type 1 Diabetes
Open Label Trial to Evaluate the Tolerability of a Combination Therapy Consisting of GAD-alum (Diamyd®), Etanercept and Vitamin D in Children and Adolescents Newly Diagnosed With Type 1 Diabetes
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Johnny Ludvigsson · Other Government
- Sex
- All
- Age
- 8 Years – 18 Years
- Healthy volunteers
- Not accepted
Summary
The objectives of this study is to: * Evaluate the tolerability of a combination therapy with Diamyd, vitamin D and etanercept * Evaluate how the above mentioned treatments influence the immune system and endogenous insulin secretion
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GAD-Alum | Recombinant Human Glutamic Acid Decarboxylase (rhGAD65) |
| DRUG | Vitamin D | |
| DRUG | Etanercept |
Timeline
- Start date
- 2015-05-01
- Primary completion
- 2019-02-25
- Completion
- 2019-02-25
- First posted
- 2015-06-08
- Last updated
- 2021-03-29
- Results posted
- 2019-09-25
Locations
8 sites across 1 country: Sweden
Source: ClinicalTrials.gov record NCT02464033. Inclusion in this directory is not an endorsement.