Response rates among all assessed patients | Response rates in patients who did not experience hypoglycaemia | ||||
---|---|---|---|---|---|
Criterion for response | Treatment groups | n/N (%) | Difference (95% CI) vs. PBO + TZD | n/N (%) | Difference (95% CI) vs. PBO + TZD |
HbA1c reduction from BL ≥ 1.0% | PBO + TZD (n = 184) | 36/180 (20.0) | – | 35/180 (19.4) | – |
SAXA 2.5 + TZD (n = 195) | 76/192 (39.6) | 19.6% (10.4%, 28.6%) | 72/192 (37.5) | 18.1% (8.9%, 27.0%) | |
SAXA 5 + TZD (n = 186) | 92/183 (50.3) | 30.3% (20.7%, 39.3%) | 89/183 (48.6) | 29.2% (19.7%, 38.2%) | |
HbA1c reduction from BL ≥ 0.7% | PBO + TZD (n = 184) | 60/180 (33.3) | – | 59/180 (32.8) | – |
SAXA 2.5 + TZD (n = 195) | 102/192 (53.1) | 19.8% (9.7%, 29.5%) | 97/192 (50.5) | 17.7% (7.7%, 27.4%) | |
SAXA 5 + TZD (n = 186) | 116/183 (63.4) | 30.1% (19.9%, 39.7%) | 112/183 (61.2) | 28.4% (18.2%, 38.1%) | |
HbA1c reduction from BL ≥ 0.5% | PBO + TZD (n = 184) | 80/180 (44.4) | – | 78/180 (43.3) | – |
SAXA 2.5 + TZD (n = 195) | 117/192 (60.9) | 16.5% (6.3%, 26.4%) | 112/192 (58.3) | 15.0% (4.8%, 24.9%) | |
SAXA 5 + TZD (n = 186) | 131/183 (71.6) | 27.1% (17.1%, 36.6%) | 127/183 (69.4) | 26.1% (15.9%, 35.7%) |
BL, baseline; CI, confidence interval; HbA1c, glycated haemoglobin; PBO, placebo; SAXA 2.5, SAXA 5, saxagliptin 2.5 or 5 mg once daily; TZD, thiazolidinedione.
Pioglitazone continued at 4 or 8 mg/day or rosiglitazone continued at 30 or 45 mg/day.