Table 1.
Linagliptin pivotal clinical trials: summary of study design.
| Monotherapy | Add-on to metformin | Add-on to metformin plus sulfonylurea | Combination with pioglitazone | |
|---|---|---|---|---|
| Reference | Del Prato et al. [2011] | Taskinen et al. [2011] | Owens et al. [2011] | Gomis et al. [2011] |
| NCT ID | NCT00621140 | NCT00601250 | NCT00602472 | NCT00641043 |
| Patients | Adults Type 2 diabetes BMI ≤40 kg/m2 | Adults Type 2 diabetes BMI ≤40 kg/m2 | Adults Type 2 diabetes BMI ≤40 kg/m2 | Adults Type 2 diabetes BMI ≤40 kg/m2 |
| Prior treatment | Treatment-naïve or treated with one other OAD (except TZDs) | Metformin as monotherapy or with one other OAD | Stable regimen of metformin and a sulfonylurea | Treatment-naïve or treated with any OAD |
| Baseline HbA1c | 7.0–10.0% (after washout of OAD) | 7.0–10.0% (after washout of OADs other than metformin) | 7.0–10.0% (no washout needed) | 7.5–11.0% (after washout of OAD) |
| Study drug | Linagliptin 5 mg | Linagliptin 5 mg | Linagliptin 5 mg | Linagliptin 5 mg + pioglitazone 30 mg |
| Comparator | Placebo | Placebo | Placebo | Placebo + pioglitazone 30 mg |
| Background therapy | None | Metformin | Metformin + sulfonylurea | None |
| Treatment period | 24 weeks | 24 weeks | 24 weeks | 24 weeks |
| Patients, n (linagliptin/comparator)1 | 503 (336/167) | 701 (523/177) | 1058 (792/263) | 389 (259/130) |
| Primary outcome measure2 | Change from baseline in HbA1c | Change from baseline in HbA1c | Change from baseline in HbA1c | Change from baseline in HbA1c |
NCT ID, ClinicalTrials.gov identification number; BMI, body mass index; OAD, oral antidiabetic drug; TZD, thiazolidinedione; HbA1c, glycosylated hemoglobin.
Adults are aged ≥18 and ≤80 years.
1
Number of patients is the treated set: all randomized patients who received ≥1 dose of study drug.
2
Change from baseline in HbA1c is adjusted for baseline HbA1c and previous antidiabetic medication.