Table 2

Primary and secondary efficacy end point results

ParameterPlaceboIONIS-PTP-1BRxP value
n2346*
HbA1c (%)
 Baseline8.4 (0.9)8.8 (1.0)
 Week 27 change from baseline−0.1 (0.8)−0.4 (0.8)0.074
 Week 36 change from baseline−0.2 (0.9)−0.7 (0.9)0.034
HbA1c (mmol/mol)
 Baseline68.2 (10.0)72.4 (10.8)
 Week 27 change from baseline−0.7 (8.4)−4.8 (9.1)0.074
 Week 36 change from baseline−1.9 (9.7)−7.5 (10.2)0.034
Fasting plasma glucose (mg/dL)
 Baseline179.5 (37.9)169.5 (40.7)
 Week 27 change from baseline−17.3 (34.5)−11.3 (40.4)0.547
 Week 36 change from baseline−7.7 (37.5)−15.9 (50.1)0.494
Fructosamine (μmol/L)
 Baseline315.3 (55.7)319.6 (50.0)
 Week 27 change from baseline−23.7 (42.5)−26.6 (36.2)0.772
 Week 36 change from baseline−3.7 (40.4)−33.2 (39.2)0.005
Glycated albumin (%)
 Baseline19.0 (4.5)19.6 (4.4)
 Week 27 change from baseline−1.0 (2.9)−1.7 (3.0)0.399
 Week 36 change from baseline0.1 (3.6)−1.6 (3.4)0.031
Leptin (ng/mL)
 Baseline14.1 (9.4)16.5 (10.8)
 Week 27 change from baseline0.4 (7.5)−4.4 (5.5)0.007
 Week 36 change from baseline1.8 (8.6)−2.5 (6.5)0.089
Adiponectin (μg/mL)
 Baseline4.7 (2.4)5.5 (3.5)
 Week 27 change from baseline0.1 (0.9)1.0 (2.0)0.020
 Week 36 change from baseline−0.1 (1.1)0.6 (1.4)0.037
High–molecular weight adiponectin (μg/mL)
 Baseline3.0 (2.0)3.6 (3.0)
 Week 27 change from baseline0.03 (0.9)0.7 (1.4)0.019
 Week 36 change from baseline0.01 (0.8)0.7 (1.1)0.015
Body weight (kg)
 Baseline96.0 (17.5)91.5 (18.7)
 Week 27 change from baseline−0.2 (2.2)−2.6 (3.3)0.002
 Week 36 change from baseline−1.4 (5.1)−2.7 (3.6)0.012
  • Data are mean (SD) and represent the per-protocol population (patients who received at least 13 doses of study drug within 15 weeks of the first dose, completed at least 23 doses, had not missed three consecutive doses, had no dose adjustments of OAD, and did not have any significant protocol deviations that would be expected to bias the patients’ pharmacodynamics assessments). Week 27 includes early termination. Baseline HbA1c is defined as the last nonmissing value before the first dose. Baseline for all other parameters is defined as the average of day −7 and day 1 predose values.

  • *n = 45 for all week 36 values.

  • P value determined by ANOVA.

  • P value determined by Wilcoxon rank sum test.