A Phase 3 interventional study of rhGAD65 and rhGAD65 in Type 1 Diabetes Mellitus, sponsored by Diamyd Therapeutics AB. Terminated at 43 sites in United States. Open to participants aged 10 Years to 20 Years. Per ClinicalTrials.gov, last updated 2012-10-10.
Sponsored by Diamyd Therapeutics AB · Phase 3, Interventional, and Treatment
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 331 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Diamyd Therapeutics AB is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Main Inclusion Criteria:
Main Exclusion Criteria:
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.
Drug: rhGAD65
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.
Drug: rhGAD65
This arm will receive 4 injections of placebo, 1 each on days 1, 30, 90 and 270.
Drug: Placebo
Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1, 30, 90 and 270.
Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1 and 30, followed by placebo injections at days 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
This study is terminated, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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Diamyd Therapeutics AB