A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (EU)
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|ClinicalTrials.gov Identifier: NCT00723411|
Recruitment Status : Terminated (The primary endpoint at 15 months was not met.)
First Posted : July 28, 2008
Last Update Posted : October 10, 2011
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Drug: rhGAD65 Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||334 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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 (EU)|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||August 2011|
Active Comparator: A
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.
Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1, 30, 90 and 270.
Active Comparator: B
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.
Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1 and 30, followed by placebo injections at days 90 and 270.
Placebo Comparator: C
This arm will receive 4 injections of placebo, 1 each on Days 1, 30, 90, and 270.
Placebo injected subcutaneously at days 1, 30, 90 and 270
- Meal stimulated C-peptide (area under the curve) [ Time Frame: 15 months ]
- HbA1c [ Time Frame: 15 months ]
- Insulin Dose [ Time Frame: 15 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00723411
|Principal Investigator:||Johnny Ludvigsson, MD, PhD||Linköping University, Sweden|