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Positive Safety Data Reported for Tradjenta (Linagliptin) in Adults With Type 2 Diabetes
Fewer hypoglycemic and renal adverse events versus placebo (September 24)
Positive results have been reported from two post hoc, pooled analyses of data from placebo-controlled clinical trials that examined the safety of the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin (Tradjenta, Boehringer Ingelheim/Eli Lilly) in adults with type 2 diabetes (T2D). The new data were presented at the 49th Annual Meeting of the European Association for the Study of Diabetes (EASD).
Findings from a pooled, post hoc analysis of safety data from 22 linagliptin clinical trials involving a total of 7,400 adults with T2D (4,810 received linagliptin and 2,590 received placebo) included the following:
- The hypoglycemic incidence rate for linagliptin compared with placebo was 11.5% vs. 14.0%, respectively.
- The overall incidence of adverse events (AEs) or serious adverse events (SAEs) with linagliptin was similar to that of placebo (AEs, 56.5% vs. 61.2%, respectively; and SAEs, 4.8% vs. 6.3%, respectively).
Another post hoc analysis evaluated pooled data from seven randomized, placebo-controlled phase III clinical trials involving a total of 1,293 adults with T2D who were 65 years old or older. The findings from this analysis included the following:
- Overall renal function, as assessed by the estimated glomerular filtration rate (eGFR), was not significantly changed by treatment with linagliptin from baseline to week 24 compared with placebo (adjusted mean eGFR of –1.8 mL/min for linagliptin vs. –1.1 mL/min for placebo).
- Renal and urinary AEs were experienced by 5.5% and 4.3% of the linagliptin- and placebo-treated patients, respectively.
- The incidence of investigator-defined hypoglycemia was lower in patients who received linagliptin compared with those given placebo (21.3% vs. 24.7%, respectively), with most events occurring in trials that included a sulfonylurea or basal insulin as background therapy.
- Acute renal failure occurred in 0.5% and 0.2% of the linagliptin and placebo groups, respectively.
The FDA has approved Tradjenta (linagliptin) for the treatment of adults with T2D as monotherapy or in combination with metformin alone or metformin plus sulfonylurea, and as add-on therapy to insulin.
Source: Eli Lilly; September 24, 2013.