Table 3.
Change from baseline at week 24 in glycated hemoglobin, body weight and fasting plasma glucose (full-analysis set)
| Parametersa | MET 500 mg bid (N = 285) | LINA/MET 500 mg bid (N = 279) | Adjusted mean difference (95% CI)b | P value | MET 1000 mg bid (N = 271) | LINA/MET 1000 mg bid (N = 281) | Adjusted mean difference (95% CI)b | P value |
|---|---|---|---|---|---|---|---|---|
| HbA1c, % | – 1.14 (0.06) | – 1.67 (0.06) | – 0.53 (– 0.69, – 0.37) | < 0.0001 | – 1.57 (0.06) | – 1.93 (0.06) | – 0.36 (– 0.52, – 0.20) | < 0.0001 |
| Fasting plasma glucose, mg/dLc | – 22.50 (2.04) | – 35.67 (2.05) | – 13.17 (–18.84, – 7.50) | < 0.0001 | –36.81 (2.10) | – 47.93 (2.05) | – 11.12 (– 16.88, – 5.36) | 0.0002 |
| Weight, kgd | – 0.63 (0.18) | – 0.20 (0.18) | 0.43 (– 0.06, 0.92) | 0.0858 | – 0.87 (0.18) | – 0.76 (0.18) | 0.12 (– 0.37, 0.61) | 0.6407 |
The full-analysis set included all patients (N = 1116) who were randomized and treated with at least one dose of study drug, had a baseline HbA1c measurement and at least one HbA1c measurement during treatment
aParameters for each treatment are presented as the adjusted mean change from baseline, with the standard error given in parenthesis
bAnalysis of covariance model includes study, treatment, continuous baseline HbA1c and the respective continuous baseline fasting plasma glucose or weight
cNumber of analyzed patients: MET 500 mg bid: N = 280; LINA/MET 500 mg bid: N = 277; MET 1000 mg bid: N = 265; LINA/MET 1000 mg bid: N = 276
dNumber of analyzed patients: MET 500 mg bid: N = 254; LINA/MET 500 mg bid: N = 259; MET 1000 mg bid: N = 252; LINA/MET 1000 mg bid: N = 264