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Table 2—

Glycemic control measurements at baseline and last double-blind visit

VariableMetforminPlaceboDifference (metformin – placebo)
Baseline mean FPG (mmol/l) 9.0 ± 2.7 10.7 ± 2.7  
Last double-blind visit mean FPG (mmol/l) 7.0 ± 2.2 11.5 ± 4.5  
Adjusted mean* FPG change from baseline (mmol/l) −2.4 ± 0.5 1.2 ± 0.5 −3.6 ± 0.8 
 95% CI   −3.5 to −1.3   0.1 to  2.3    5.1 to −2.0 
P     <0.001 
Baseline mean HbA1c (%) 8.2 ± 1.3 8.9 ± 1.4  
Last double-blind visit mean HbA1c (%) 7.2 ± 1.2 8.9 ± 1.6  
Adjusted mean* HbA1c (%) 7.5 ± 0.2 8.6 ± 0.2 −1.2 ± 0.2 
 95% CI   (7.2–7.8)  (8.3–9.0)   (−1.6–−0.7) 
P§     <0.001 
VariableMetforminPlaceboDifference (metformin – placebo)
Baseline mean FPG (mmol/l) 9.0 ± 2.7 10.7 ± 2.7  
Last double-blind visit mean FPG (mmol/l) 7.0 ± 2.2 11.5 ± 4.5  
Adjusted mean* FPG change from baseline (mmol/l) −2.4 ± 0.5 1.2 ± 0.5 −3.6 ± 0.8 
 95% CI   −3.5 to −1.3   0.1 to  2.3    5.1 to −2.0 
P     <0.001 
Baseline mean HbA1c (%) 8.2 ± 1.3 8.9 ± 1.4  
Last double-blind visit mean HbA1c (%) 7.2 ± 1.2 8.9 ± 1.6  
Adjusted mean* HbA1c (%) 7.5 ± 0.2 8.6 ± 0.2 −1.2 ± 0.2 
 95% CI   (7.2–7.8)  (8.3–9.0)   (−1.6–−0.7) 
P§     <0.001 

Data are means ± SD unless otherwise indicated.

*

Mean adjusted for baseline FPG or for baseline HbA1c.

The P value is based on an ANCOVA, comparing metformin to placebo using baseline FPG as the covariate and treatment as the main effect.

Significance level P < 0.03355, where the testwise critical value was adjusted for an 8-week interim analysis of FPG, to preserve an overall α level of ≤0.05 using the O’Brien-Fleming method with an α of 0.025 at the interim analysis.

§

P value is based on an ANCOVA, comparing metformin to placebo using baseline HbA1c as the covariate and treatment as the main effect.

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