| September 11, 2008 |
| November 18, 2009 |
| August 2008 |
| October 2010 (final data collection date for primary outcome measure) |
| Meal Stimulated C-peptide (area under the curve) [ Time Frame: 15 months ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00751842 on ClinicalTrials.gov Archive Site |
- HbA1c [ Time Frame: 15 months ] [ Designated as safety issue: No ]
- Insulin Dose [ Time Frame: 15 months ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (USA)- DIAPREVENT |
| A Phase III, 3-Arm, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Impact of Diamyd on the Progression of Diabetes in Patients Newly Diagnosed With Type 1 Diabetes Mellitus (USA) |
The purpose of this study is to determine whether Diamyd (rhGAD65 formulated in alum) is effective in preserving the body's own insulin producing capacity in patients recently diagnosed with type 1 diabetes. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Type 1 Diabetes Mellitus |
- Drug: rhGAD65
- Drug: Placebo
|
- Active Comparator: This arm will receive 2 subcutaneous injections with 20 µg Diamyd on days 1 and 30, i.e., 1 prime and 1 booster dose, followed by 2 additional single doses with Diamyd 20 µg on days 90 and 270.
- Active Comparator: This arm will receive 2 subcutaneous injections with 20 µg Diamyd on days 1 and 30, i.e., 1 prime and 1 booster dose, followed by 2 additional single doses with placebo on days 90 and 270.
- Placebo Comparator: This arm will receive 4 injections of placebo, 1 each on days 1, 30, 90 and 270.
|
| |
| |
| Recruiting |
| 320 |
| October 2011 |
| October 2010 (final data collection date for primary outcome measure) |
Main Inclusion Criteria:
Main Exclusion Criteria:
- Treatment with immunosuppressants or any anti-diabetic medications other than insulin
- A history of certain diseases or conditions (e.g. anemia, HIV, hepatitis, epilepsy, head trauma, neurological diseases or cerebrovascular accident, alcohol or drug abuse etc)
- Treatment with any vaccine within 1 month prior to planned first Diamyd dose or planned treatment with vaccine up to 2 months after the last injection with Diamyd, excluding the influenza vaccine
- Participation in other clinical trials with a new chemical entity within the previous 3 months
- Pregnancy or planned pregnancy within 1 year after the last Diamyd dose
- Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study
|
| Both |
| 10 Years to 20 Years |
| No |
|
|
| United States |
| |
| NCT00751842 |
| Managing Director, Diamyd Therapeutics AB |
| D/P3/07/5 |
| Diamyd Therapeutics AB |
|
| Principal Investigator: |
Jerry Palmer, Professor |
University of Washington |
|
|
| Diamyd Therapeutics AB |
| November 2009 |
