Trajenta launched for type II diabetes

Trajenta (linagliptin) is a new once daily DPP4 inhibitor that does not require dose adjustment in renal impairment.

New once daily DPP4 inhibitor that does not require dose adjustment in renal impairment
New once daily DPP4 inhibitor that does not require dose adjustment in renal impairment

PHARMACOLOGY

Linagliptin is a dipetidyl peptidase 4 (DPP4) inhibitor: it prevents the breakdown of incretin hormones, leading to a glucose-dependent improvement in glycaemic control. Linagliptin excretion occurs primarily via the faeces, with approximately 5% undergoing renal excretion. Consequently, there is no requirement for dose adjustment in patients
with renal impairment. As a result of its long half-life, linagliptin requires only once daily administration.1

CLINICAL STUDIES

The efficacy, safety and tolerability of linagliptin monotherapy in 227 patients for whom  metformin was inappropriate were assessed in an 18-week, randomised, double-blind, placebo-controlled study. At 18 weeks, the adjusted mean treatment difference for HbA1c between linagliptin and placebo was -0.57% (p<0.0001) in favour of linagliptin. In patients who had a baseline HbA1c ≥7.0%, 11.8% of those on placebo and 23.5% of those receiving linagliptin achieved an HbA1c of <7.0%. Linagliptin was also superior to placebo at reducing fasting plasma glucose from baseline to week 18 with an adjusted mean difference of -1.1mmol/l (p=0.0002).2

Linagliptin as an adjunct to metformin was assessed in a 24-week, randomised, double-blind, placebo-controlled, multicentre study (n=701). This study evaluated the efficacy and safety in patients with type II diabetes with inadequate glycaemic control. Participants had HbA1c levels of 7.0–10.0% (mean 8.1%) on metformin and were taking a maximum of one other antidiabetic agent, which was discontinued on study entry. After 24 weeks, linagliptin had reduced the adjusted mean HbA1c to a greater extent than placebo (adjusted mean treatment difference -0.64%; p<0.0001). A significant reduction in adjusted mean fasting plasma glucose levels was also seen for linagliptin compared with placebo, representing a treatment effect of -1.2mmol/l (p<0.0001).3

The safety and efficacy of linagliptin was compared with placebo as adjunct to metformin and a sulfonylurea in 1058 patients with type II diabetes with inadequate glycaemic control was evaluated in a phase 3 study. After 24 weeks, linagliptin had reduced the adjusted mean HbA1c to a greater extent than placebo (adjusted mean treatment difference -0.62%; p<0.0001). More patients with a baseline HbA1c ≥7.0% achieved an HbA1c <7.0% with linagliptin (29.2%) than with placebo (8.1%; p<0.0001).4

Adverse events occurred at a similar rate in the placebo and active treatment groups of the linagliptin studies.1 The most common side-effect was hypoglycaemia, seen in triple therapy.

REFERENCES

  1. Trajenta Summary of Product Characteristics, August 2011.
  2. Barnett AH et al. Poster presented at the 46th annual meeting of European Association for the  Study of Diabetes. Stockholm, Sweden, September 2010; P823.
  3. Taskinen MR et al. Diabetes Obes Metab 2011; 13: 65–74.
  4. Owens DR et al. Diabet Med 2011, Accepted article; DOI:10.1111/j.1464-5491.2011.03387.x

View Trajenta drug record

Further information: Boehringer Ingelheim Ltd


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