Table 1.
Important clinical studies in the Phase III program with linagliptin (studies with ≥24 weeks duration)
| Reference | Background therapy | Comparator(s) (n randomized)/treatment arms | Baseline HbA1c (%), ±SD | HbA1c change from baseline (%), ±SD | Placebo/comparator-corrected HbA1c reduction (%), (means ±SD or 95% CI) | Duration (weeks) |
|---|---|---|---|---|---|---|
| Del Prato et al29 | Therapy naïve/wash-out | PBO (n = 167) | 8.0 ± 0.91 | −0.46 ± 0.73 (12 weeks) | NR (12 weeks) | 12 |
| 1 previous OAD | LINA 5 mg (n = 333) | −0.44 ± 0.91 (24 weeks) | −0.69 ± 0.08 (24 weeks) | 24 | ||
| Kawamori et al30 | Therapy naïve/wash-out | PBO (n = 80) | 7.95 ± 0.67 | 0.63 (0.08) (SE) | 12 vs placebo | |
| 1–2 previous OAD | LINA 5 mg (n = 159) | 8.07 ± 0.66 | −0.24 (0.06) (SE) vs PBO | −0.87 (−1.04, −0.70) | ||
| LINA 10 mg (n = 160) | 7.98 ± 0.68 | −0.25 (0.06) (SE) vs PBO | −0.88 (−1.05, −0.71) | |||
| VO (0.2 mg tid) | 8.02 ± 0.71 | 0.19 (0.07) | 26 vs VO | |||
| LINA 5 mg (n = 159) | cf | −0.13 (0.07) (SE) vs VO | −0.32 (−0.49, −0.15) | |||
| LINA 10 mg (n = 160) | cf | −0.19 (0.07) (SE) vs VO | −0.39 (−0.56, −0.21) | |||
| Taskinen et al31 | Add-on to MET | PBO (n = 177) | 8.02 ± 0.07 | 0.15 ± 0.06 | ||
| LINA 5 mg (n = 524) | 8.09 ± 0.04 | −0.49 ± 0.04 | −0.64 (−0.78, −0.50) | 24 | ||
| Owens et al32 | Add-on to MET plus sulfonylurea | PBO (n = 265) | 8.14 (0.05) (SE) | |||
| LINA 5 mg (n = 793) | 8.15 (0.03) (SE) | NR | −0.62 (−0.73, −0.50) | 24 | ||
| Gallwitz et al33 | Add-on to MET | LINA 5 mg (n = 776) | 7.17 (0.04) (SE) | −0.56 (0.03) (SE) | 0.08 (0.04) (SE) (completers cohort) | |
| Glimepiride mean dose 3 mg (week 28–104) (n = 775) | 7.31 (0.04) (SE) | −0.63 (0.03) (SE) | 104 | |||
| Haak et al34 | Initial combination with MET | PBO (n = 72) | 8.7 ± 1.0 | 0.1 ± 0.1 | ||
| LINA 5 mg (n = 142) | 8.7 ± 1.0 | −0.5 ± 0.1 | −0.6 ± 0.1 | |||
| MET 500 mg bid (n = 144) | 8.7 ± 0.90 | −0.6 ± 0.1 | −0.8 ± 0.1 | |||
| MET 1000 mg bid (n = 147) | 8.5 ± 0.90 | −1.1 ± 0.1 | −1.2 ± 0.1 | |||
| LINA 2.5 mg + MET 500 mg bid (n = 143) | 8.7 ± 1.0 | −1.2 ± 0.1 | −1.3 ± 0.1 | |||
| LINA 2.5 mg + MET 1000 mg bid (n = 143) | 8.7 ± 1.0 | −1.6 ± 0.1 | −1.7 ± 0.1 | |||
| Open label LINA + MET (n = 66) | 11.8 ± 1.4 | −3.7 ± 1.7 | NR | 24 | ||
| Gomis et al35 | Initial combination with pioglitazone (30 mg) | PBO + pioglitazone (n = 130) | 8.58 (0.08) (SE) | −0.56 (0.09) (SE) | ||
| LINA 5 mg + pioglitazone (n = 259) | 8.60 (0.05) (SE) | −1.06 (0.06) | −0.51 (0.10) (SE) | 24 |
Note: cf: see corresponding linagliptin arms in this study with 5 and 10 mg, respectively.
Abbreviations: OAD, oral antidiabetic drug; FDC, fixed-dose combination; NR, not reported; PBO, placebo; VO, voglibose; LINA, linagliptin; MET, metformin; SE, standard error.