Table 2.
Secondary endpoints
| Baseline | 3 months | 6 months | 12 months | ||
|---|---|---|---|---|---|
| Percentage of participants with maximal stimulated serum C-peptide > 0.2 pmol ml−1 | Treatment | 100 | 100 | 97.6 | 85.7 |
| Placebo | 100 | 93.6 | 86.4 | 66.7 | |
| HbA1c, mmol mol−1 (s.d.) | Treatment | 87.6 (18.1) | 32.7 (9.9)* | 38.5 (12.5)* | 48.4 (12.2) |
| Placebo | 84.7 (16.2) | 44.6 (8.3) | 48.5 (8.1) | 50.9 (7.6) | |
| HbA1c, % (s.d.) | Treatment | 10.2 (3.8) | 5.1 (3.1)* | 5.7 (3.3)* | 6.6 (3.3) |
| Placebo | 9.9 (3.6) | 6.2 (2.9) | 6.6 (2.9) | 6.8 (2.8) | |
| Glycated albumin, % (s.d.) | Treatment | 15.5 (1.8) | 11 (1.8) | 11.7 (2.2) | 12.1 (2) |
| Placebo | 15.7 (1.8) | 11.6 (1.8) | 12.2 (1.5) | 12.7 (1.6) | |
| IDAA1c, % (s.d.) | Treatment | 13.2 (2.5) | 7.2 (1.7)* | 8.2 (2.2)** | 9.9 (2.2) |
| Placebo | 12.8 (2.3) | 8.2 (1.4) | 8.9 (1.5) | 9.9 (1.7) | |
| Insulin dose, U kg−1 body weight per day (s.d.) | Treatment | 0.8 (0.4) | 0.8 (0.3) | 1.1 (0.4) | 1.3 (0.5) |
| Placebo | 0.7 (0.3) | 0.8 (0.4) | 0.9 (0.3) | 1.1 (0.4) | |
| Insulin pumps, n patients | Treatment | 19 | 26 | 25 | 32 |
| Placebo | 15 | 26 | 30 | 33 |
*P < 0.001, **P = 0.008. All other P values were not significant (P > 0.05).