Glycaemic responses at 24 weeks with saxagliptin + metformin* as initial combination therapy vs. metformin* monotherapy in drug-naive patients
| 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 + MET | n/N (%) | Difference (95% CI) vs. PBO + MET |
| HbA1c reduction from BL ≥ 2.5% | MET (n = 328) | 106/313 (33.9) | – | 99/313 (31.6) | – |
| SAXA 5 + MET (n = 320) | 157/306 (51.3) | 17.4% (9.6%, 25.1%) | 151/306 (49.3) | 17.7% (10.0%, 25.2%) | |
| HbA1c reduction from BL ≥ 2.0% | MET (n = 328) | 156/313 (49.8) | – | 148/313 (47.3) | – |
| SAXA 5 + MET (n = 320) | 209/306 (68.3) | 18.5% (10.7%, 26.0%) | 201/306 (65.7) | 18.4% (10.6%, 26.0%) | |
| HbA1c reduction from BL ≥ 1.5% | MET (n = 328) | 200/313 (63.9) | – | 190/313 (60.7) | – |
| SAXA 5 + MET (n = 320) | 233/306 (76.1) | 12.2% (5.0%, 19.4%) | 223/306 (72.9) | 12.2% (4.7%, 19.5%) | |
| HbA1c reduction from BL ≥ 1.0% | MET (n = 328) | 243/313 (77.6) | – | 231/313 (73.8) | – |
| SAXA 5 + MET (n = 320) | 268/306 (87.6) | 9.9% (4.0%, 15.9%) | 257/306 (84.0) | 10.2% (3.8%, 16.6%) | |
| HbA1c reduction from BL ≥ 0.7% | MET (n = 328) | 256/313 (81.8) | – | ND | |
| SAXA 5 + MET (n = 320) | 286/306 (93.5) | 17.8% (12.3%, 23.4%) | |||
| HbA1c reduction from BL ≥ 0.5% | MET (n = 328) | 270/313 (86.3) | – | ND | |
| SAXA 5 + MET (n = 320) | 293/306 (95.8) | 15.3% (10.5%, 20.5%) | |||
BL, baseline; CI, confidence interval; HbA1c, glycated haemoglobin; MET, metformin; ND, not determined; PBO, placebo; SAXA 5, saxagliptin 5 mg once daily. n/N, number of responders/number assessed.
*
Metformin titrated up to target dosage of 2000 mg/day.