Table 1

Efficacy end points and treatment group differences at week 24 (full analysis set)

TI (n = 177)TP (n = 176)Treatment difference (TI − TP) at week 24
HbA1c, %Baseline (SE) [baseline value in mmol/mol]8.25 (0.06) [67.2]8.27 (0.06) [67.2]
Adjusted mean change (SE) [adjusted mean change in mmol/mol]−0.82 (0.06) [−9.0]−0.42 (0.06) [−4.6]−0.40 (0.09) [−4.4]a
95% CI; P−0.57, −0.23 [−6.2, −2.5]; <0.0001
HbA1c ≤7.0% [53.0 mmol/mol]Incidence, n (%)57 (37.7)27 (19.0)
Odds ratio (95% CI); P2.726b (1.55, 4.80); 0.0005
HbA1c ≤6.5% [47.5 mmol/mol]Incidence, n (%)24 (15.9)6 (4.2)
Odds ratio (95% CI); P4.361b (1.70, 11.17); 0.0021
FPG, mg/dLBaseline (SE)175.91 (2.97)175.19 (2.99)
Adjusted mean change (SE)−11.20 (3.78)−3.78 (3.86)−7.42 (5.400)c
95% CI; P−18.03, 3.18; 0.1698
Body weight, kgBaseline (SE)90.15 (1.29)90.79 (1.31)
Adjusted mean change (SE)0.49 (0.33)−1.13 (0.35)1.62 (0.365)d
95% CI; P0.90, 2.34; <0.0001
  • n is the number of randomized patients. For analysis of secondary efficacy end points, P values were provided for descriptive purposes only.

  • aAdjusted means, 95% CI, and P value are based on the MMRM analysis with covariance autoregressive (first-order) structure and the following model: HbA1c = baseline HbA1c + region + pooled OAD stratum + visit + treatment + treatment * visit.

  • bOdds ratio, 95% CI, and P value are derived from logistic regression analysis with treatment, pooled OAD stratum, region, and baseline HbA1c in the model. Percentages are based on number of subjects who have valid measurement at week 24 within corresponding baseline category. Subjects who received rescue therapy during the treatment phase are considered as nonresponders at week 24.

  • cAdjusted means, 95% CI, and P value are based on the MMRM analysis with covariance autoregressive (first-order) structure and the following model: FPG = baseline FPG + region + pooled OAD stratum + visit + treatment + treatment * visit.

  • dAdjusted means, 95% CI, and P value are based on the ANCOVA analysis with the following model: change from baseline in weight = baseline weight + region + change in HbA1c at week 24 + pooled OAD stratum + treatment.