A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (USA)- DIAPREVENT
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|ClinicalTrials.gov Identifier: NCT00751842|
Recruitment Status : Terminated (Based on other clinical trial results it was unlikely the study would meet the efficacy endpoints)
First Posted : September 12, 2008
Last Update Posted : October 10, 2012
The intended purpose of this study was 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.
Based on results from other clinical trials with the study drug it was judged unlikely this study would meet the intended primary or secondary efficacy endpoints. Therefore the primary focus of this study was changed to ensure that safety data was available for at least 6 months following the last dose of active study drug. Thereafter the study was terminated.
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Drug: rhGAD65 Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||331 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 (USA)|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||July 2012|
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): NCT00751842
|Principal Investigator:||Jerry Palmer, Professor||University of Washington|