Table 1.
Weight and glycosylated hemoglobin changes observed in linagliptin clinical trials
| Study | Treatment | Mean baseline weight (kg) | Mean weight change in kg (% body weight) | Mean baseline HbA1c (%) | Mean adjusted HbA1c change (%) | Placebo-corrected HbA1c difference (%) |
|---|---|---|---|---|---|---|
| Monotherapy | ||||||
| Barnett et al30 | Linagliptin 5 mg (18 weeks) | 77 | −1.3 (1.7) | 8.1 | −0.4 | −0.6 |
| Placebo | 81 | −2.1 (2.6) | 8.1 | +0.2 | ||
|
| ||||||
| Del Prato et al32 | Linagliptin 5 mg (24 weeks) | 79 | NR; NS | 8.0 | −0.4 | −0.7 |
| Placebo | 79 | NR; NS | 8.0 | +0.3 | ||
|
| ||||||
| Kawamori et al41 | Linagliptin 5 mg (26 weeks) | NR | NR | 8.1 | −0.2 | −0.9 |
| Placebo | 8.0 | +0.6 | ||||
|
| ||||||
| Forst et al91 | Linagliptin 5 mg (4 weeks) | NR | NR | 6.8 | −0.1 | −0.4 |
| Placebo | 7.3 | +0.3 | ||||
|
| ||||||
| Dual combination therapy | ||||||
| Forst et al33 | Linagliptin 5 mg added to metformin (12 weeks) | 91 | −0.6 (0.7) | 8.5 | −0.5 | −0.7 |
| Placebo added to metformin | 93 | −0.8 (0.9) | 8.4 | +0.2 | ||
|
| ||||||
| Taskinen et al34 | Linagliptin 5 mg added to metformin (24 weeks) | 82 | −0.4 (0.5) | 8.1 | −0.5 | −0.6 |
| Placebo added to metformin | 83 | −0.5 (0.6) | 8.0 | +0.2 | ||
|
| ||||||
| Gallwitz et al44 | Linagliptin 5 mg added to metformin (2 years) | 86 | −1.4 (1.6) | 7.7 | −0.2 | 0.2a |
| SU added to metformin | 87 | +1.3 (1.5) | 7.7 | −0.4 | ||
|
| ||||||
| Lewin et al39 | Linagliptin 5 mg added to SU (18 weeks) | 75 | +0.4 (0.5) | 8.6 | −0.5 | −0.5 |
| Placebo added to SU | 76 | −0.01 (0.01) | 8.6 | −0.1 | ||
|
| ||||||
| Ross et al93 | Linagliptin 2.5 mg (twice daily) added to metformin (12 weeks) + | 82 | −0.4 (0.5) | 8.0 | −0.5 | −0.7 |
| Linagliptin 5 mg added to metformin | 81 | −1.0 (1.2) | 8.0 | −0.5 | −0.8 | |
| Placebo + metformin | 78 | −1.1 (1.4) | 7.9 | +0.3 | ||
|
| ||||||
| Initial dual combination therapy | ||||||
| Haak et al36 | Linagliptin 5 mg (24 weeks) | 79 | +0.2 (0.3) | 8.7 | −0.5 | −0.6 |
| Metformin 1,000 mg twice daily | 80 | −0.5 (0.6) | 8.5 | −1.1 | −1.2 | |
| Linagliptin 2.5 mg + metformin 1,000 mg twice daily | 77 | −0.8 (1.0) | 8.7 | −1.6 | −1.7 | |
| Linagliptin 2.5 mg + metformin 500 mg twice daily | 81 | −0.1 (0.1) | 8.7 | −1.2 | −1.3 | |
| Placebo | 77 | −0.7 (0.9) | 8.7 | +0.1 | ||
|
| ||||||
| Gomis et al38 | Pioglitazone (24 weeks) + placebo | 83 | +1.3 (1.6) | 8.6 | −0.6 | −0.5 |
| Linagliptin 5 mg + pioglitazone | 78 | +2.7 (3.5) | 8.6 | −1.1 | ||
|
| ||||||
| Triple combination therapy | ||||||
| Owens et al35 | Linagliptin 5 mg added to metformin + SU (24 weeks) | 77 | +0.3 (0.4) | 8.2 | −0.7 | −0.6 |
| Placebo added to metformin + SU | 77 | −0.1 (0.1) | 8.1 | −0.1 | ||
Note:
a
Treatment difference (linagliptin–glimepiride).
Abbreviations: HbA1c, glycosylated hemoglobin; NR, not reported; NS, not significant; SU, sulfonylurea.