Table 2.
Studies of linagliptin exclusively in Asian T2DM patients
| Studies | Patients | Race | Intervention | Study duration | Major outcomes | Findings |
|---|---|---|---|---|---|---|
| Horie et al13 | 72 patients on lifestyle intervention or 1–2 OADs | Japanese | Linagliptin of different doses: 0.5 mg, 2.5 mg, 10 mg daily and placebo | 4 wks | 1) Change of HbA1c at 4 wks 2) Change of FPG 3) Change of GLP-1 4) Adverse events |
1) −0.31% (P<0.01), −0.2% (NS), −0.44% (P<0.01) (0.5 mg, 2.5 mg, 10 mg linagliptin) vs 0.04% (placebo) 2) −11.5 mg/dL, −13.6 mg/dL, −25 mg/dL (0.5 mg, 2.5 mg, 10 mg linagliptin) vs −3.2 mg/dL (placebo), P<0.05 3) 3.4 nmol/L (NS), 4.1 nmol/L (NS), 7.2 nmol/L (P<0.001) (0.5 mg, 2.5 mg, 10 mg linagliptin) vs 2.5 nmol/L (placebo) 4) 10.5%, 27.8%, 22.2% (0.5 mg, 2.5 mg, 10 mg linagliptin) vs 35.3% (placebo) (NS) |
| Kawamori et al25 | 561 patients previously on OADs or drug-naïve | Japanese | Linagliptin 5 mg and 10 mg daily vs placebo vs voglibose 0.2 mg tid | 12 wks (linagliptin vs placebo) 26 wks (linagliptin vs voglibose) |
1) Change of HbA1c at 12 wks 2) Change of HbA1c at 26 wks 3) Drug-related adverse event |
1) −0.24%, −0.25% (5 mg, 10 mg linagliptin) vs 0.63% (placebo), P<0.0001 2) −0.13%, −0.19% (5 mg, 10 mg linagliptin) vs 0.19% (voglibose) 3) 9.4% linagliptin 5 mg, 8.8% linagliptin 10 mg, 10% placebo at 12 wks; 11.3% linagliptin 5 mg, 10.6% linagliptin 10 mg, 18.5% voglibose at 26 wks |
| Araki et al34 | 494 patients who completed the previous study with comparator groups switched to linagliptin | Japanese | Linagliptin 5 mg and 10 mg daily | 26 wks | 1) Drug-related adverse event 2) Change of body weight 3) Change of HbA1c at 26 wks 4) Change in FPG |
1) 10.2%, 10.6% (5 mg, 10 mg linagliptin) 2) −0.11 kg, −0.07 kg (5 mg, 10 mg linagliptin) 3) −0.35%, −0.29% (5 mg, 10 mg linagliptin) 4) −0.7 mmol/L, −0.6 mmol/L (5 mg, 10 mg linagliptin) |
| Inagaki et al26 | 618 patients on sulphonylurea or α-glucosidase inhibitors | Japanese | Linagliptin 5 mg daily vs Metformin bid or tid, up to 2,250 mg/day | 52 wks | 1) Change of HbA1c at 52 wks 2) Hypoglycemic attack rates |
1) 20.7%–20.9% (linagliptin) vs 20.8%–21.0% (metformin) (NS) 2) 1.6%–13.7% (linagliptin) vs 3.2–15.9% (metformin), NS |
| Zeng et al31 | 192 patients on metformin and sulphonylurea | Chinese | Linagliptin 5 mg daily vs placebo | 24 wks | 1) Change of HbA1c at 24 wks 2) Change in FPG 3) Adverse event rates |
1) −0.59% (linagliptin) vs 0.08% (placebo), P<0.0001 2) −3.9 mg/dL (linagliptin) vs 15.0 mg/dL (placebo), P<0.001 3) 38.9% (linagliptin) vs 43.8% (placebo), NS |
Abbreviations: T2DM, type 2 diabetes mellitus; OAD, oral antidiabetic drug; wks, weeks; GLP-1, glucagon-like peptide-1; NS, nonsignificant; FPG, fasting plasma glucose.