Table 1.
Baseline characteristics for the full analysis set of parts 1 and 2
| Part 1 | Part 2 | |||
|---|---|---|---|---|
| Placebo (n = 11) | TTP399 (n = 8) | Placebo (n = 43) | TTP399 (n = 38) | |
| Female sex, n (%) | 8 (73) | 5 (63) | 24 (56) | 14 (37) |
| Age (years), mean (SD) | 47 (10) | 38 (15) | 42 (13) | 43 (15) |
| Race, n (%) | ||||
| White | 11 (100) | 7 (87) | 41 (95) | 36 (95) |
| Black or African American | 0 | 1 (13) | 1 (2) | 0 |
| Asian | 0 | 0 | 1 (2) | 2 (5) |
| Non-Hispanic or non-Latino ethnicity, n (%) | 11 (100) | 8 (100) | 41 (95) | 37 (97) |
| Weight (kg), mean (SD) | 82.8 (15.1) | 80.2 (14.3) | 83.6 (15.0) | 83.1 (18.4) |
| BMI (kg/m2), mean (SD) | 29.0 (4.1) | 28.4 (3.3) | 28.3 (3.8) | 27.6 (4.0) |
| Age at type 1 diabetes diagnosis (years), mean (SD) | 18 (11) | 9 (7) | 16 (10) | 16 (9) |
| Duration of diabetes (years), mean (SD) | 29 (17) | 29 (16) | 26 (14) | 26 (13) |
| Insulin pump user, n (%) | 11 (100) | 8 (100) | 27 (63) | 20 (53) |
| CGM user, n (%) | 11 (100) | 8 (100) | 25 (58) | 24 (63) |
| Fasting plasma glucose (mg/dL), mean (SD) | ND | ND | 153 (49) | 141 (59) |
| HbA1c, mean (SD) | ||||
| % | 7.4 (0.4) | 7.2 (0.4) | 7.5 (0.60) | 7.6 (0.6) |
| mmol/mol | 57 (4.5) | 55 (4.7) | 59 (6.5) | 60 (5.8) |
| β-Hydroxybutyrate (mmol/L), mean (SD) | 0.19 (0.32) | 0.12 (0.21) | 0.14 (0.25) | 0.11 (0.12) |
| C-peptide, mean (SD) | ||||
| ng/ml | 0.10 (0.10) | 0.10 (0.05) | 0.09 (0.17) | 0.05 (0.09) |
| nmol/L | 0.03 (0.03) | 0.03 (0.02) | 0.03 (0.06) | 0.02 (0.03) |
| Undetectable (<0.004 ng/mL), n (%) | 5 (45) | 5 (63) | 22 (51) | 20 (53) |
| Daily insulin dose (IU), mean (SD) | ||||
| Total | 48.9 (13.9) | 52.6 (14.1) | 55.8 (22.2) | 57.5 (29.3) |
| Basal | 26.0 (7.5) | 30.0 (4.7) | 29.8 (13.9) | 30.4 (13.9) |
| Bolus | 22.8 (8.8) | 22.6 (12.3) | 26.0 (12.5) | 27.0 (18.7) |
| Daily insulin dose/mass (IU/kg), mean (SD) | ||||
| Total | 0.59 (0.14) | 0.65 (0.11) | 0.65 (0.19) | 0.68 (0.27) |
| Basal | 0.31 (0.07) | 0.38 (0.06) | 0.35 (0.13) | 0.37 (0.15) |
| Bolus | 0.28 (0.10) | 0.27 (0.13) | 0.30 (0.12) | 0.32 (0.17) |
| CGM average glucose reading (mg/dL), mean (SD) | 159 (14) | 155 (15) | 158 (26) | 167 (30) |
| CGM TIR, % (SD) | ||||
| <54 mg/dL | 1 (1) | 1 (1) | 4 (4) | 4 (4) |
| <70 mg/dL | 3 (3) | 3 (3) | 9 (6) | 9 (9) |
| In target (70–180 mg/dL) | 64 (10) | 67 (10) | 57 (11) | 52 (13) |
| >180 mg/dL | 33 (11) | 30 (11) | 34 (14) | 39 (16) |
| >250 mg/dL | 6 (4) | 6 (4) | 11 (8) | 15 (10) |
Baseline CGM values are for the 14 days before the day-1 visit. Data from CGM were obtained from Dexcom (unblinded) and Abbott Freestyle Libre Pro in parts 1 and 2, respectively. ND, not done.