Table 1 Characteristics of trials used in analysis
From: A standardized metric to enhance clinical trial design and outcome interpretation in type 1 diabetes
Trial | Start Year | N Treatment Arm(s) | N Control Arm | Age, median (range) | Baseline C-peptide AUC Mean (nmol/L), mean (SD) | Primary outcome/ time point | Primary Study Result |
|---|---|---|---|---|---|---|---|
Diamyd Therapeutics AB: GAD-Alum Phase 2 | 2005 | 35 | 35 | 13.9 (10.1, 18.4) | 0.66 (0.37) | Fasting C-peptide at 15 months | Negative |
Diamyd Therapeutics AB: GAD-Alum Phase 3 | 2008 | 107 (2 doses), 109 (4 doses) | 111 | 13.2 (10, 19.3) | 0.66 (0.32) | 2-h MMTT AUC C-peptide at 15 months | Negative |
Immune Tolerance Network (ITN): Anti-thymocyte globulin (ATG) | 2007 | 38 | 20 | 17.5 (12, 35) | 0.88 (0.42) | 2-h MMTT AUC C-peptide at 1 year | Negative |
Immune Tolerance Network (ITN): Alefacept | 2011 | 33 | 16 | 18 (12, 34) | 0.78 (0.38) | 2-h MMTT AUC C-peptide at 1 year (secondary 4-h MMTT AUC C-peptide at 1 year) | Negative primary; Positive secondary |
Immune Tolerance Network (ITN): Teplizumab | 2005 | 52 | 25 | 12 (8.3, 29.6) | 0.7 (0.3) | 4-h MMTT AUC C-peptide at 2 years | Positive |
Immune Tolerance Network (ITN): Tocilizumab | 2015 | 88 | 47 | 14 (6, 45) | 0.76 (0.43) | 2-h MMTT AUC C-peptide at 1 year | Negative |
JDRF: Imatinib | 2014 | 43 | 21 | 24.5 (18.3, 45) | 0.84 (0.4) | 2-h MMTT AUC C-peptide at 1 year | Positive |
TrialNet: Abatacept | 2008 | 76 | 35 | 12.9 (6.4, 36.8) | 0.75 (0.38) | 2-h MMTT AUC C-peptide at 2 years | Positive |
TrialNet: Canakinumab | 2010 | 48 | 22 | 11 (6, 31.9) | 0.64 (0.33) | 2-h MMTT AUC C-peptide at 1 year | Negative |
TrialNet: GAD-Alum | 2009 | 49 (2 doses), 48 (3 doses) | 48 | 15.1 (3.5, 45.7) | 0.73 (0.32) | 2-h MMTT AUC C-peptide at 1 year | Negative |
TrialNet: Low Dose ATG/GCSF | 2014 | 29 (ATG only), 28 (ATG/GCSF) | 31 | 16 (12, 42.5) | 0.89 (0.44) | 2-h MMTT AUC C-peptide at 1 year | Positive |
TrialNet: MMF/DZB | 2004 | 31 (MMF only), 41 (MMF/DZB) | 42 | 14.9 (8.7, 46.1) | 0.69 (0.32) | 2-h MMTT AUC C-peptide at 1 year | Negative |
TrialNet: Rituximab | 2005 | 55 | 30 | 16 (8.3, 40.4) | 0.75 (0.39) | 2-h MMTT AUC C-peptide at 1 year | Positive |
