Table 2.
Summary of sitagliptin trials (all doses are in milligrams [mg])
| Trial | Number | Duration in weeks | Intervention | Reduction glycated hemoglobin (%) | Comments |
|---|---|---|---|---|---|
| Aschner et al38 | 741 | 24 | S100 S200 |
−0.79 −0.94 |
β-cell function improved |
| Raz et al39 | 521 | 18 | S100 S200 |
−0.60 −0.48 |
β-cell function improved |
| Scott et al40 | 743 | 12 | S2.5 od S12.5 od S25 od S50 bid |
Reductions in all groups | Maximum reduction with 50 mg bid |
| Goldstein et al41 | 1,091 | 24 | S100 S100 + M1000 S100 + M2000 M1000 |
−0.83 −1.57 −2.07 −0.99 |
Additive hypoglycemic effect with combination therapy |
| Nonaka et al43 | 151 | 12 | S100 | −0.65 | Significantly reduced 2-hour postprandial glucose |
| Mohan et al44 | 530 | 18 | S100 | −1.0 | Significantly reduced 2-hour postprandial glucose |
| Charbonnel et al47 | 701 | 24 | M ≥ 1,500 Add on S100 |
−0.65 | β-cell function improved |
| Scott el al48 | 273 | 18 | M ≥ 1,500 Add on S100 M ≥ 1,500 Add on R8 |
−0.73 −0.79 |
>3 kg weight gain in 21% glitazone-treated group vs 2% sitagliptin group |
| Nauck et al49 | 1,172 | 52 | M ≥ 1500 Add on S100 M ≥ 1500 Add on GL5–20 |
−0.67 −0.67 |
Hypoglycemia rate was 5% with sitagliptin vs 32% in glipizide group |
| Pérez-Monteverde et al52 | 492 | 18 phase A 28 phase B |
S100 P15–30 S + M (50/1000 bid) P45 |
−1.0 −0.9 −1.7 −1.4 |
Weight reduction with S + M |
| Hermansen et al36 | 441 | 24 | Gm + M Add on S100 Gm Add on S100 |
−0.89 −0.57 |
Higher incidence of hypoglycemia when sitagliptin is added to sulfonylurea |
| Rosenstock et al54 | 175 | 24 | P30–45 Add on S100 |
−0.70 | Well tolerated Low risk of hypoglycemia |
| Fonseca et al56 | 313 | 26 | M ≥ 1500 + P ≥ 30 Add on S100 |
0.70 | Well tolerated Low risk of hypoglycemia |
| Sitagliptin use in chronic kidney disease | |||||
| Chan et al59 | 91 | 54 | S25–50 | −0.70 | Well tolerated in chronic renal impairment |
| Arjona Ferreira et al60 | 426 | 54 | S25–50 GL2.5–20 |
Sitagliptin noninferior to glipizide | Higher hypoglycemia risk with glipizide |
| Arjona Ferreira et al61 | 129 | 54 | S25 GL2.5–20 |
−0.72 −0.89 |
Well tolerated Low risk of hypoglycemia compared with glipizide |
Abbreviations: bid, twice daily; GL, glipizide; Gm, glimepiride; M, metformin; od, once daily; P, pioglitazone; R, rosiglitazone; S, sitagliptin.