Table 3.
Summary of CGM and CGM-derived results and prespecified insulin dose analysis
| Placebo (N = 17) |
Sotagliflozin (N = 16) |
P | |||||
|---|---|---|---|---|---|---|---|
| Baseline | Treatment | Change from baseline value [%] | Baseline | Treatment | Change from baseline value [%] | ||
| CGM mean daily glucose (mg/dL) | 160.6 (25.9) | 170.3 (24.0) | 5.9 [NC] | 163.6 (38.7) | 148.8 (18.0)* | −14.0 [NC] | 0.010 |
| CGM hypoglycemia events/patient/day (≥10 continuous min <70 mg/dL) | 1.09 (1.01) | 0.90 (0.47) | −0.2 [NC] | 1.06 (0.59) | 0.95 (0.41) | −0.1 [NC] | 0.75 |
| CGM % time in ranges (mg/dL) | |||||||
| <70 | 8.5 (9.5) | 5.8 (4.7) | −2.3 [NC] | 7.9 (7.3) | 6.7 (5.0) | −1.5 [NC] | 0.80 |
| 70–180 | 55.9 (12.1) | 54.0 (12.0) | −0.2 [NC] | 56.4 (15.6) | 68.2 (12.1)* | 11.6 [NC] | 0.003 |
| >180 | 35.6 (14.4) | 40.2 (13.7) | 2.5 [NC] | 35.7 (18.3) | 25.0 (11.2)* | −10.1 [NC] | 0.002 |
| >250 | 12.0 (9.3) | 14.1 (7.9) | 1.1 [NC] | 15.3 (14.8) | 6.7 (6.6)* | −7.9 [NC] | 0.008 |
| CGM variability measures | |||||||
| SD (mg/dL) | 57.2 (13.9) | 58.8 (9.6) | 1.2 [NC] | 60.5 (16.5) | 50.0 (12.2)* | −8.9 [NC] | 0.022 |
| Coefficient of variation | 35.6 (8.8) | 35.4 (5.2) | 0.3 [NC] | 37.4 (5.2) | 33.7 (6.0) | −2.9 [NC] | 0.41 |
| MAGE | 135.5 (34.9) | 145.5 (25.6) | 7.5 [NC] | 145.5 (39.5) | 120.8 (30.5)* | −20.0 [NC] | 0.041 |
| HBGI | 8.7 (3.7) | 9.7 (3.7) | 0.5 [NC] | 9.2 (6.5) | 6.2 (3.1)* | −2.9 [NC] | 0.006 |
| LBGI | 2.2 (2.2) | 1.5 (1.1)* | −0.6 [NC] | 1.9 (1.5) | 1.8 (1.2) | −0.2 [NC] | 0.61 |
| Insulin dose data | |||||||
| Total daily bolus (primary) | 20.9 (14.0) | 18.8 (11.2) | −2.1 [−6.4] | 23.0 (11.6) | 15.4 (9.2) | −7.3 [−32.0] | 0.007 |
| Total daily basal | 26.1 (9.4) | 25.9 (9.3) | −0.2 [0.2] | 27.1 (7.1) | 26.6 (8.7) | −0.5 [−2.4] | 0.53 |
| Total daily (basal + bolus) | 45.9 (17.5) | 44.4 (15.5) | −1.5 [−0.7] | 47.0 (17.9) | 37.6 (15.3) | −7.6 [−15.3] | 0.029 |
| Breakfast bolus | 4.8 (4.1) | 4.4 (2.9) | — [13.6] | 5.6 (3.6) | 3.4 (2.0) | — [−28.4] | 0.046 |
| Lunch bolus | 5.6 (4.8) | 5.0 (3.9) | — [7.1] | 6.4 (3.9) | 4.4 (2.7) | — [−25.9] | 0.08 |
| Dinner bolus | 6.2 (5.7) | 5.8 (4.2) | — [39.3] | 7.2 (4.1) | 5.3 (3.4) | — [−23.8] | 0.052 |
Data are mean (SD) unless otherwise indicated. Arithmetic change from baseline is shown; P values are from least squares mean analyses of change from baseline scores (absolute and % change). The baseline analysis period consists of days −6 to −2, and the treatment analysis period consists of days 3–27. LBGI, low blood glucose index; NC, not calculated.
*P < 0.05, change from baseline. Bold values are statistically significant.