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Table 1—

Body weight and glycated A1C levels at baseline and mean adjusted change from baseline and insulin dose in patients with type 1 or type 2 diabetes randomized to inhaled human insulin (Exubera) or SC insulin for 6 months

Type 1 diabetes
Type 2 diabetes
Exuberan or n (%)SC insulinn or n (%)Difference between adjusted mean changes (95% CI)Exuberan or n (%)SC insulinn or n (%)Difference between adjusted mean changes (95% CI)
Male  275 (55.4)  277 (54.3)   283 (66.9)  274 (64.0)  
Female  221 (44.6)  233 (45.7)   140 (33.1)  154 (36.0)  
Body weight at baseline (kg) (pooled analysis) 76.0 ± 14.0 496 75.0 ± 13.4 510  88.5 ± 14.9 423 88.5 ± 15.0 428  
    Quattrin et al. (ref. 7)* 77.4 ± 14.9 135 76.4 ± 13.0 134       
    Skyler et al. (ref. 8)* 76.0 ± 13.6 103 76.9 ± 14.1 104       
    Skyler et al. (ref. 9) 75.1 ± 13.6 286 73.8 ± 13.1 285       
    Hollander et al. (ref. 10)      90.6 ± 14.5 147 89.0 ± 13.7 149  
    Rosenstock et al. (ref. 11)      87.1 ± 14.8 312 88.4 ± 15.4 302  
Adjusted change from baseline 0.2 ± 0.1 496 1.1 ± 0.1 510 −0.87 (−1.24 to −0.50) 0.7 ± 0.2 423 1.6 ± 0.2 428 −0.93 (−1.39 to −0.48) 
        in body weight (kg) (pooled analysis)§           
    Quattrin et al. (ref. 7)* 0.4 ± 0.3  1.1 ± 0.3  −0.72 (−1.48 to 0.04)      
    Skyler et al. (ref. 8)* 0.4 ± 0.3  0.6 ± 0.3  −0.24 (−1.07 to 0.59)      
    Skyler et al. (ref. 9) (6-month assessment) 0.01 ± 0.21 258 1.15 ± 0.24 272 −1.14 (90% CI −1.63 to −0.65)      
    Skyler et al. (ref. 9) (24-month assessment) 0.9 ± 0.2 208 2.1 ± 0.3 217 −1.26 (90% CI −1.80 to −0.71)      
    Hollander et al. (ref. 10)      0.1 ± 0.2  1.3 ± 0.2  −1.28 (−1.96 to −0.60) 
    Rosenstock et al. (ref. 11) (6-month assessment)      1.2 ± 0.23 276 1.9 ± 0.25 279 −0.75 (90% CI −1.27 to −0.22) 
    Rosenstock et al. (ref. 11) (24-month assessment)      1.97 ± 0.26 218 3.30 ± 0.27 224 −1.33 (90% CI −1.92 to −0.75) 
A1C at baseline (pooled analysis) 7.6 ± 1.0 500 7.7 ± 1.0 509  7.8 ± 1.1 425 7.9 ± 1.1 437  
Adjusted change from baseline A1C (pooled analysis)§ −0.2 (0.03)  −0.3 (0.03)  0.09 (0.00 to 0.18) −0.7 ± 0.05  −0.6 ± 0.04  −0.07 (−0.19 to 0.05) 
Mean daily insulin dose at study end (short-acting insulin/intermediate- or long-acting insulin)           
    Quattrin et al. (ref. 7)* 14.2/28.7  18.2/40.9        
    Skyler et al. (ref. 8)* 12.0/37.7  28.1/37.9        
    Skyler et al. (ref. 9) (6-month assessment) 11.3/31.1  25.0/35.5        
    Skyler et al. (ref. 9) (24-month assessment) 14.7/31.8  25.4/36.2        
    Hollander et al. (ref. 10)      16.6/37.9  25.5/52.3   
    Rosenstock et al. (ref. 11) (6-month assessment)      13.2/43.8  31.2/45.9   
    Rosenstock et al. (ref. 11) (24-month assessment)      15.9/46.6  34.7/50.1   
Type 1 diabetes
Type 2 diabetes
Exuberan or n (%)SC insulinn or n (%)Difference between adjusted mean changes (95% CI)Exuberan or n (%)SC insulinn or n (%)Difference between adjusted mean changes (95% CI)
Male  275 (55.4)  277 (54.3)   283 (66.9)  274 (64.0)  
Female  221 (44.6)  233 (45.7)   140 (33.1)  154 (36.0)  
Body weight at baseline (kg) (pooled analysis) 76.0 ± 14.0 496 75.0 ± 13.4 510  88.5 ± 14.9 423 88.5 ± 15.0 428  
    Quattrin et al. (ref. 7)* 77.4 ± 14.9 135 76.4 ± 13.0 134       
    Skyler et al. (ref. 8)* 76.0 ± 13.6 103 76.9 ± 14.1 104       
    Skyler et al. (ref. 9) 75.1 ± 13.6 286 73.8 ± 13.1 285       
    Hollander et al. (ref. 10)      90.6 ± 14.5 147 89.0 ± 13.7 149  
    Rosenstock et al. (ref. 11)      87.1 ± 14.8 312 88.4 ± 15.4 302  
Adjusted change from baseline 0.2 ± 0.1 496 1.1 ± 0.1 510 −0.87 (−1.24 to −0.50) 0.7 ± 0.2 423 1.6 ± 0.2 428 −0.93 (−1.39 to −0.48) 
        in body weight (kg) (pooled analysis)§           
    Quattrin et al. (ref. 7)* 0.4 ± 0.3  1.1 ± 0.3  −0.72 (−1.48 to 0.04)      
    Skyler et al. (ref. 8)* 0.4 ± 0.3  0.6 ± 0.3  −0.24 (−1.07 to 0.59)      
    Skyler et al. (ref. 9) (6-month assessment) 0.01 ± 0.21 258 1.15 ± 0.24 272 −1.14 (90% CI −1.63 to −0.65)      
    Skyler et al. (ref. 9) (24-month assessment) 0.9 ± 0.2 208 2.1 ± 0.3 217 −1.26 (90% CI −1.80 to −0.71)      
    Hollander et al. (ref. 10)      0.1 ± 0.2  1.3 ± 0.2  −1.28 (−1.96 to −0.60) 
    Rosenstock et al. (ref. 11) (6-month assessment)      1.2 ± 0.23 276 1.9 ± 0.25 279 −0.75 (90% CI −1.27 to −0.22) 
    Rosenstock et al. (ref. 11) (24-month assessment)      1.97 ± 0.26 218 3.30 ± 0.27 224 −1.33 (90% CI −1.92 to −0.75) 
A1C at baseline (pooled analysis) 7.6 ± 1.0 500 7.7 ± 1.0 509  7.8 ± 1.1 425 7.9 ± 1.1 437  
Adjusted change from baseline A1C (pooled analysis)§ −0.2 (0.03)  −0.3 (0.03)  0.09 (0.00 to 0.18) −0.7 ± 0.05  −0.6 ± 0.04  −0.07 (−0.19 to 0.05) 
Mean daily insulin dose at study end (short-acting insulin/intermediate- or long-acting insulin)           
    Quattrin et al. (ref. 7)* 14.2/28.7  18.2/40.9        
    Skyler et al. (ref. 8)* 12.0/37.7  28.1/37.9        
    Skyler et al. (ref. 9) (6-month assessment) 11.3/31.1  25.0/35.5        
    Skyler et al. (ref. 9) (24-month assessment) 14.7/31.8  25.4/36.2        
    Hollander et al. (ref. 10)      16.6/37.9  25.5/52.3   
    Rosenstock et al. (ref. 11) (6-month assessment)      13.2/43.8  31.2/45.9   
    Rosenstock et al. (ref. 11) (24-month assessment)      15.9/46.6  34.7/50.1   

Data are means ± SD unless otherwise indicated.

*

Data published in Quattrin et al. (ref. 7) and Skyler et al. (ref. 8) were combined adult and pediatric data, whereas the data reported in the table are from adults only.

Results in the table reflect the intent-to-treat population, whereas Hollander et al. (ref. 10) reported the per protocol population. Conclusions reached from these two populations are the same.

Means ± SE.

§

Least-squares means (±SE) based on the primary model with terms for baseline, treatment, and study.

Exubera was measured in milligrams and SC insulin in units; 1 mg Exubera is approximately equivalent to 2–3 units subcutaneously injected fast-acting human insulin.

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