sp;
Number of patients n = 243 n = 122
Baseline (mean) 188.4 186.4
Change from baseline (adjusted mean) -32.6 -18.4
Difference from placebo + pioglitazone (adjusted mean) (95% CI) -14.2 (-21.1, -7.3)
Add-On Combination with Sulfonylureas
A total of 245 patients with type 2 diabetes participated in an 18-week, randomized, double-blind, placebo-controlled study designed to assess the efficacy of linagliptin in combination with sulfonylurea (SU). Patients on sulfonylurea monotherapy (n = 142) were randomized after completing a 2-week single-blind placebo run-in period. Patients on a sulfonylurea plus one additional oral antihyperglycemic agent (n = 103) were randomized after a wash-out period of 4 weeks and a 2-week single-blind placebo run-in period. Patients were randomized to the addition of linagliptin 5 mg or to placebo, each administered once daily. Patients who failed to meet specific glycemic goals during the studies were treated with metformin rescue. Glycemic endpoints measured included A1C and FPG.
In combination with a sulfonylurea, linagliptin provided statistically significant improvements in A1C compared with placebo following 18 weeks treatment; the improvements in FPG observed with linagliptin were not statistically significant compared with placebo (Table 8). Rescue therapy was used in 7.6% of patients treated with linagliptin 5 mg and 15.9% of patients treated with placebo. There was no significant difference between linagliptin and placebo in body weight.
Table 8 Glycemic Parameters at in Placebo-Controlled Study for TRADJENTA in Combination with Sulfonylurea* TRADJENTA 5 mg + SU Placebo + SU
SU = sulfonylurea
*Full analysis population using last observation on study
A1C (%)
Number of patients n = 158 n = 82
Baseline (mean) 8.6 8.6
Change from baseline (adjusted mean) -0.5 -0.1
Difference from placebo + SU (adjusted mean) (95% CI) -0.5 (-0.7, -0.2) --
Patients (%) achieving A1C <7% 15.2 3.7
FPG (mg/dL)
Number of patients n = 155 n = 78
Baseline (mean) 180 171
Change from baseline (adjusted mean) -8.2 -1.8
Difference from placebo + SU (adjusted mean) (95% CI) -6.4 (-17.2, 4.3) --
Add-On Combination Therapy with Metformin and a Sulfonylurea
A total of 1058 patients with type 2 diabetes participated in a 24-week, randomized, double-blind, placebo-controlled study designed to assess the efficacy of linagliptin in combination with a sulfonylurea and metformin. The most common sulfonylureas used by patients in the study were: glimepiride (31%), glibenclamide (26%), and gliclazide (26%, not available in the United States). Patients on a sulfonylurea and metformin were randomized to receive linagliptin 5 mg or placebo, each administered once daily. Patients who failed to meet specific glycemic goals during the study were treated with pioglitazone rescue. Glycemic endpoints measured included A1C and FPG.
In combination with a sulfonylurea and metformin, TRADJENTA provided statistically significant improvements in A1C and FPG compared with placebo (Table 9). In the entire study population (patients on TRADJENTA in combination with sulfonylurea and metformin), a mean reduction from baseline relative to placebo in A1C of -0.6% and in FPG of -12.7 mg/dL was seen. Rescue th
