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Data support safety profile of Trajenta®



Boehringer Ingelheim and Eli Lilly and Company have announced that results from two different pooled analyses of clinical studies support previous observations that the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin was shown to be well tolerated in a broad range of adults with Type 2 Diabetes (T2D).  These data were presented at the 49th European Association of Diabetes (EASD) Annual Meeting.
General safety analysis
Findings from a pooled comprehensive analysis of safety data in 22 linagliptin clinical trials with 7,400 people with T2D (4,810 received linagliptin, 2,590 received placebo) included the following:[1]
  • Linagliptin was well tolerated overall and across all age groups studied, with a low incidence of hypoglycemic events
  • In an exploratory analysis, overall hypoglycaemia was lower for linagliptin compared to placebo (11.5% versus 14%, p=0.0021)
  • Overall incidence of adverse events (AE) or serious adverse events (SAE) with linagliptin was similar to placebo (AE 56.5% versus 61.2%, and SAE 4.8% versus 6.3%, respectively)
  • The incidence of AEs with linagliptin compared to placebo remained similar irrespective of the age category (≤65 years, 65-74 years, ≥75 years)
“Drug tolerability is an important consideration in the selection of appropriate treatments for people with Type 2 Diabetes, as often different populations will have drug contraindications and require dose adjustments to manage their disease,” said Prof. Nikolaus Marx, Professor of Medicine and Cardiology, University Hospital of Aachen, Germany. “The results presented today support the safety profile of linagliptin.”
Renal safety in the elderly
Results from a post-hoc analysis of pooled data from seven clinical trials including 1,293 people with T2D aged 65 years or older showed:[2]
  • Linagliptin was well tolerated providing clinical efficacy in an elderly population with renal function ranging from normal to severe renal impairment
  • Overall renal function was not significantly altered by treatment with linagliptin from baseline to week 24, versus placebo
  • Patients taking linagliptin achieved a HbA1c reduction of -0.6% from baseline and −0.8 mmol/L for fasting plasma glucose (both values placebo-corrected)
  • The overall incidence of AEs with linagliptin was similar to placebo (71.3% versus 72.8%, respectively)
  • Incidence of investigator-defined hypoglycaemia was not higher in patients who received linagliptin compared to those receiving placebo (21.3% versus 24.7%), with most events occurring in the trials that included a sulphonylurea or basal insulin as background therapy
  • Renal and urinary AEs were experienced by 5.5% and 4.3% of linagliptin and placebo patients, respectively.
“The data presented from these analyses supplement the already established evidence demonstrating that linagliptin is a well-tolerated treatment for a broad range of people with Type 2 Diabetes,” said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. “This should provide physicians further assurance when treating different patient types with linagliptin.”
The US Food and Drug Administration (FDA), European Medicines Agency (EMA) and several other regulatory authorities worldwide have approved linagliptin for the treatment of adults with T2D as monotherapy or in combination with metformin, metformin + sulphonylurea, and as add-on therapy to insulin. With linagliptin, no dose adjustment is required regardless of renal function or hepatic impairment.[3,4]
  1. Lehrke M et al. Safety and tolerability of linagliptin in 7,400 patients with Type 2 Diabetes: A pooled comprehensive analysis of prospective safety reporting in placebo-controlled studies. Poster No: 986. Presented at the European Association for the Study of Diabetes (EASD), September 23-27, Barcelona
  2. Patel S et al. Renal safety of linagliptin in elderly patients with Type 2 Diabetes: analysis of pooled patient data from seven Phase III clinical trials. Poster No: 926. Presented at the European Association for the Study of Diabetes (EASD), September 23-27, Barcelona
  3. Tradjenta™ (linagliptin) tablets. Highlights of Prescribing Information. Initial US Approval: 2011.
  4. EMA. Trajenta® (linagliptin) tablets. EMA Summary of Product Characteristics. 2011.

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