Table 2.
Prespecified outcomes for the full analysis set
| Part 1 | Part 2 | |||
|---|---|---|---|---|
| Placebo (n = 11) | TTP399 (n = 8) | Placebo (n = 43) | TTP399 (n = 38) | |
| HbA1c (mmol/mol) | ||||
| Baseline, mean (SD) | 57 (4.5) | 55 (4.7) | 59 (6.5) | 60 (5.8) |
| Week 12 change from baseline, mean (SE) | 0.9 (2.2) | −6.6 (2.3) | 0.8 (0.7) | −0.15 (0.7) |
| Treatment effect, mean (95% CI) | NA | −7.5 (−14.2, −0.8; P = 0.032) | NA | −2.3 (−4.3, −0.4; P = 0.018) |
| HbA1c (%) | ||||
| Baseline, mean (SD) | 7.4 (0.4) | 7.2 (0.4) | 7.5 (0.6) | 7.6 (0.6) |
| Week 12 change from baseline, mean (SE) | 0.08 (0.2) | −0.60 (0.2) | 0.07 (0.06) | −0.14 (0.06) |
| Treatment effect, mean (95% CI) | NA | −0.69 (−1.3, −0.07; P = 0.032) | NA | −0.21 (−0.39, −0.04; P = 0.018) |
| Responders | ||||
| Proportion with composite response, n (%) | 0 | 5 (62) | 5 (12) | 16 (42) |
| Treatment effect, OR (95% CI) | NA | 11.8 (2.58, 20.98; P = 0.016) | NA | 7.8 (0.93, 14.68; P = 0.027) |
| Time in target range (daytime*) (%) | ||||
| Baseline, mean (SD) | 65 (13) | 70 (9) | 57 (11) | 51 (14) |
| Week 12 change from baseline, mean (SD) | −9.2 (2.5) | 2.6 (3.4) | −7.8 (2.3) | 0.1 (2.6) |
| Treatment effect, mean (95% CI) | NA | 11.8 (2.58, 20.98; P = 0.016) | NA | 7.8 (0.93, 14.68; P = 0.027) |
| Time in target range (24 h†) (%), mean (SD) | ||||
| Baseline | 64 (10) | 67 (10) | 57 (11) | 52 (13) |
| Week 12 change from baseline | −8 (10) | −3 (8) | −7 (14) | 0.5 (16) |
| Time in hypoglycemia <70 mg/mL (%), mean (SD) | ||||
| Baseline | 3 (3) | 3 (3) | 9 (6) | 9 (6) |
| Week 12 change from baseline | −1 (3) | −1 (3) | −2 (5) | −2 (8) |
| Time in hypoglycemia <54 mg/mL (%), median (min, max) | ||||
| Baseline | 0.2 (0, 2) | 0.1 (0, 3) | 2 (0, 15) | 3 (0, 13) |
| Week 12 change from baseline | −0.1 (−2, 2) | −0.1 (−3, 0) | −0.5 (−8, 8) | −0.5 (−8, 22) |
| Time in hyperglycemia >180 mg/mL (%), mean (SD) | ||||
| Baseline | 33 (11) | 30 (11) | 34 (14) | 39 (16) |
| Week 12 change from baseline | 9 (12) | 5 (8) | 10 (17) | 1 (18) |
| Quality of life slightly or significantly improved, n (%) | 5 (45) | 6 (75) | 18 (42) | 20 (53) |
| Total insulin use (units/kg/day), mean (SD) | ||||
| Baseline | 0.59 (0.14) | 0.65 (0.10) | 0.65 (0.19) | 0.68 (0.27) |
| Change from baseline to week 12 (%) | −0.1 (8.7) | −1.7 (14.7) | −1.6 (16.0) | −7.6 (10.1) |
| Bolus insulin use (units/kg/day), mean (SD) | ||||
| Baseline | 0.28 (0.10) | 0.27 (0.13) | 0.30 (0.12) | 0.32 (0.17) |
| Change from baseline to week 12 (%) | −5.9 (17.5) | −1.0 (31.8) | −3.9 (28.4) | −8.4 (22.7) |
| Basal insulin use (units/kg/day), mean (SD) | ||||
| Baseline | 0.31 (0.07) | 0.38 (0.06) | 0.35 (0.13) | 0.37 (0.15) |
| Change from baseline to week 12 (%) | 4.4 (7.7) | −2.3 (10.3) | −0.5 (11.6) | −5.4 (7.1) |
NA, not applicable; OR, odds ratio.
*Daytime was defined as 6:00 a.m. to 10:00 p.m.
†24-h TIR was not prespecified in the statistical analysis plan.