| February 15, 2007 |
| January 29, 2008 |
| January 2005 |
| October 2007 (final data collection date for primary outcome measure) |
| 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). |
| Same as current |
| Complete list of historical versions of study NCT00435981 on ClinicalTrials.gov Archive Site |
| To evaluate the safety of Diamyd® 20ug. |
| Same as current |
| |
| 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 |
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. |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Type 1 Diabetes |
| Drug: rhGAD65 formulated in Alhydrogel® (Diamyd®) |
| |
| Ludvigsson J, Faresjö M, Hjorth M, Axelsson S, Chéramy M, Pihl M, Vaarala O, Forsander G, Ivarsson S, Johansson C, Lindh A, Nilsson NO, Aman J, Ortqvist E, Zerhouni P, Casas R. GAD treatment and insulin secretion in recent-onset type 1 diabetes. N Engl J Med. 2008 Oct 30;359(18):1909-20. Epub 2008 Oct 8. |
| |
| Completed |
| 70 |
| December 2007 |
| October 2007 (final data collection date for primary outcome measure) |
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)
|
| Both |
| 10 Years to 18 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Sweden |
| |
| NCT00435981 |
|
| D/P2/04/3, EUDRACT 2004-003764-30 |
| Diamyd Therapeutics AB |
|
| Principal Investigator: |
Johnny Ludvigsson, MD, PhD |
Div of Pediatrics, Dept of Clinical and Molecular Medicine, Faculty of Health Sciences, Linkoping University, Sweden |
|
|
| Diamyd Therapeutics AB |
| January 2008 |
