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Tradjenta (linagliptin) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – May 2012
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
- The safety evaluation of linagliptin 5 mg once daily in patient with type 2 diabetes is based on 13 placebo-controlled trials and 1 active-controlled study. In the 13 placebo-controlled studies, a total of 2994 patients were randomized and treated with TRADJENTA 5 mg daily and 1546 with placebo. The mean exposure across studies was 21.4 weeks. The maximum follow-up was 78 weeks.
- NOTE: multiple updated changes to numbers in Table 1 and section 6.1
8 USE IN SPECIFIC POPULATIONS
- These changes are based on the safety and efficacy results from trial 1218.46, entitled “A Phase 3, randomized, double-blind, placebo-controlled parallel group study to compare the efficacy and safety of twice daily administration of the free combination of linagliptin 2.5 mg + metformin 500 mg or of linagliptin 2.5 mg + metformin 1000 mg, with the individual components of metformin (500 mg or 1000 mg, twice daily) and linagliptin (5 mg, once daily) over 24 weeks in drug naive or previously treated (4 weeks washout and 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycemic control.” The efficacy and safety of trial 1218.46 was fully reviewed under the Jentadueto (linagliptin/metformin fixed-dose combination) NDA (201281).