Table 2. Primary and secondary overall effectiveness end points by regions (ITT population).
| Parameter | Overall, N=43 791 | Europe, n=22 073 | India, n=10 692 | Middle East, n=4779 | Latin America, n=3846 | East Asia, n=2401 |
|---|---|---|---|---|---|---|
| Primary effectiveness end pointa | ||||||
| Success rate | 23 533 (53.7) | 10 642 (48.2) | 6738 (63.0) | 3301 (69.1) | 2229 (58.0) | 623 (26.0) |
| Non-evaluable | 11 395 (26.0) | 5877 (26.6) | 2442 (22.8) | 858 (18.0) | 1048 (27.3) | 1170 (48.7) |
| OR (95% CI) | 1 | 0.8 (0.81, 0.87) | 1.5 (1.47, 1.59) | 2.0 (1.90, 2.12) | 1.2 (1.17, 1.31) | 0.3 (0.29, 0.34) |
| Secondary effectiveness end pointb | ||||||
| Success rate | 11 040 (30.8) | 5498 (32.7) | 2002 (20.4) | 1922 (43.0) | 1306 (42.0) | 312 (19.0) |
| Non-evaluable | 6897 (19.2) | 3754 (22.3) | 1158 (11.8) | 631 (14.1) | 608 (19.6) | 746 (45.5) |
| OR (95% CI) | 1 | 1.1 (1.07, 1.16) | 0.6 (0.56, 0.62) | 1.7 (1.63, 1.82) | 1.7 (1.56, 1.77) | 0.5 (0.49, 0.59) |
Abbreviations: CI, confidence interval; ITT, intention-to-treat; OR, odds ratio.
a
The proportion of patients in all the five regions achieving a glycated hemoglobin (HbA1c) reduction of >0.3% without any tolerability issues, such as peripheral edema, hypoglycemia, discontinuation owing to a gastrointestinal event or a weight gain of ⩾5% at 12 months.
b
In patients with a baseline HbA1c of ⩾7.0%, achievement of the target HbA1c of <7.0% at the 12-month end point, without a weight gain of ⩾3% at 12 months or hypoglycemic event.