Table 2

Change from baseline at week 24 (week 8 for seated SBP) for efficacy end points (excluding data after rescue)

Placebo
(N = 108)Dapagliflozin 10 mg/day
(N = 108)
HbA1c, % [mmol/mol]P < 0.0001*
 Baseline (SD)8.24 (0.87) [67 (9.5)]8.08 (0.91) [65 (9.9)]
 Adjusted mean change (95% CI)−0.17 (–0.31 to –0.02) [–1.9 (–3.4 to –0.2)]−0.86 (–1.00 to –0.72) [–9.4 (–10.9 to –7.9)]
 Adjusted placebo-subtracted mean change (SE)−0.69 (0.10) [–7.5 (1.1)]
FPG, mg/dL [mmol/L]P < 0.0001*
 Baseline (SD)180.5 (43.3) [10.02 (2.40)]167.4 (43.3) [9.29 (2.40)]
 Adjusted mean change (95% CI)−0.8 (–7.6 to 6.0) [–0.04 (–0.42 to 0.33)]−34.2 (–41.0 to –27.5) [–1.90 (–2.27 to –1.53)]
 Adjusted placebo-subtracted mean change (SE)−33.5 (4.9) [–1.86 (0.27)]
Body weight, kgP < 0.0001*
 Baseline (SD)90.1 (16.2)88.6 (17.6)
 Adjusted mean change (95% CI)−0.6 (–1.1 to –0.1)−2.7 (–3.2 to –2.1)
 Adjusted placebo-subtracted mean change (SE)−2.1 (0.4)
Seated SBP at week 8, mmHgP = 0.0250*
 Baseline (SD)136.3 (14.4)134.7 (12.7)
 Adjusted mean change (95% CI)−0.3 (–2.6 to 2.1)−4.0 (–6.4 to –1.7)
 Adjusted placebo-subtracted mean change (SE)−3.8 (1.7)
Proportion of patients with HbA1c <7.0% (53 mmol/mol), %P < 0.0001*
 Proportion (95% CI)11.1 (5.4 to 16.8)31.8 (23.3 to 40.2)
 Adjusted placebo-subtracted mean change (SE)20.7 (5.06)
Fasting total cholesterol, mg/dLP = 0.0091
 Baseline (SD)172.2 (35.6)179.5 (45.3)
 Week 24 (SD)168.8 (34.1)184.5 (43.4)
 Adjusted mean change (95% CI)−5.0 (–11.0 to 1.1)6.4 (0.5 to 12.4)
 Adjusted placebo-subtracted mean change (SE)11.4 (4.3)
Fasting LDL cholesterol, mg/dLP = 0.0030
 Baseline (SD)91.3 (29.6)96.4 (38.4)
 Week 24 (SD)86.6 (28.1)101.1 (39.4)
 Adjusted mean change (95% CI)−5.7 (–11.0 to –0.4)5.6 (0.4 to 10.9)
 Adjusted placebo-subtracted mean change (SE)11.4 (3.8)
Fasting HDL cholesterol, mg/dLP = 0.0172
 Baseline (SD)45.1 (10.5)47.6 (12.3)
 Week 24 (SD)45.2 (10.9)49.5 (12.2)
 Adjusted mean change (95% CI)−0.1 (–1.4 to 1.1)2.1 (0.8 to 3.3)
 Adjusted placebo-subtracted mean change (SE)2.2 (0.9)
LDL/HDL ratioP = 0.2008
 Baseline (SD)2.1 (0.9)2.1 (0.9)
 Week 24 (SD)2.0 (0.8)2.1 (0.9)
 Adjusted mean change (95% CI)−0.1 (–0.2 to 0.0)0.0 (–0.1 to 0.2)
 Adjusted placebo-subtracted mean change (SE)0.1 (0.1)
Fasting triglycerides, mg/dLP = 0.1755
 Baseline (SD)190.9 (148.1)184.7 (127.5)
 Week 24 (SD)193.1 (115.5)173.8 (99.1)
 Adjusted mean change (95% CI)3.9 (–13.2 to 20.9)−12.6 (–29.4 to 4.2)
 Adjusted placebo-subtracted mean change (SE)−16.5 (12.1)
C-peptide, ng/mLP = 0.1731
 Baseline (SD)2.50 (0.94)2.51 (1.07)
 Adjusted mean change (95% CI)−0.04 (–0.16 to 0.07)−0.16 (–0.27 to –0.04)
 Adjusted placebo-subtracted mean change (SE)−0.11 (0.08)
  • N is the number of patients in the full analysis set.

  • Longitudinal analysis.

  • LOCF.

  • * Significant P value for primary end point tested at α = 0.050 and key secondary end points tested sequentially at α = 0.050. For all other variables, including changes from baseline in lipids and C-peptide, nominal P values are reported without significance testing. Logistic regression analysis of responses is based on the methodology of Zhang et al., with adjustment for baseline value (27).