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Efficacy Profile
Explore the Trajenta® clinical trial program.
- Over 6,600 adults with T2DM were included in the clinical program, including patients with renal impairment and the elderly (aged ≥70 years)
- Statistical significance as monotherapy was not shown in the renal or elderly population
- Trajenta® has been studied as:1
- Monotherapy*
- Add-on combination therapy with metformin, a sulfonylurea, metformin and a sulfonylurea, metformin and empagliflozin, or insulin
In patients for whom metformin is inappropriate due to contraindications or intolerance.
Explore Trajenta®: Demonstrated significant A1C reductions at 24 weeks.
- Trajenta® as monotherapy provided significant A1C reductions vs. placebo at 24 weeks1,8*
Mean baseline A1C: 8.0%.
![A1C graph showing the demonstrated mean change in A1C for Trajenta® and placebo over 24 weeks. Described under the heading A1C at 24 weeks graph full text](https://pro.boehringer-ingelheim.com/ca/products/trajenta/images/efficacy-chart-3-mb.png)
- In another study, Trajenta®, as add-on to metformin therapy, provided significant improvements in A1C compared to placebo at 24 weeks1,9† -0.64%, p<0.0001; change from baseline: -0.49% Trajenta® + metformin (n=513) vs. +0.15% placebo + metformin (n=175)
- SE
- =standard error.
A multicentre, randomized, parallel group, phase III study that compared linagliptin with placebo for 24 weeks in patients with T2DM.
A multicentre, randomized, double-blind, placebo-control 24-week study that evaluated the efficacy and safety of linagliptin in combination with metformin versus placebo plus metformin in patients with T2DM.
Explore Trajenta®: Demonstrated A1C reductions across a range of renal functions.
Mild, moderate or severe renal function decline had no impact on the treatment effect of Trajenta®1
- RCT
- =randomized controlled trial.
Pooled analysis of the effect of renal impairment in patients with normal renal function, and patients with mild or moderate renal impairment. eGFR was estimated according to the Modification of Diet in Renal Disease (MDRD) formula.
Double-blind study evaluating the efficacy and safety of linagliptin vs. placebo in patients with severe renal impairment. Patients on dialysis were excluded. Background therapies were kept stable for the first 12 weeks of the study.
Explore Trajenta®: Demonstrated powerful and sustained A1C reduction at 102 weeks.
Mean over time (%); mean baseline A1C: 8.15%
![A1C graph showing the demonstrated reduction in A1C from baseline over 102 weeks for Trajenta®. Described under the heading A1C at 102 weeks graph full text.](https://pro.boehringer-ingelheim.com/ca/products/trajenta/images/efficacy-chart-mb.png)
- A1C reductions achieved in Trajenta® patients in 24-week placebo-controlled, double-blind trials were sustained in an open-label extension trial for an additional 78 weeks1,10,11*†
An open-label extension trial was conducted in patients who completed the 24-week treatment period of 4 placebo-controlled studies. In this extension trial, all patients received Trajenta® 5 mg as monotherapy or as add-on to background therapy they took in the previous trial. The treatment duration in this study was 78 weeks (patients from the placebo and Trajenta® arms of the initial trial received Trajenta® in this trial for 78 and 102 weeks, respectively).
One of the included studies, 1218.15, evaluated a combination of Trajenta® and a thiazolidinedione which is not indicated for use in Canada.
Explore Trajenta®: Demonstrated significant A1C and FBG improvements in elderly patients as add-on therapy (aged ≥70 years).
Patients (aged ≥70 years) received Trajenta® as add‑on to metformin and/or sulfonylurea and/or basal insulin.A1C reduction vs. placebo after 24 weeks1*
![A visual of 2 downward arrows displaying demonstrated A1C and FBG outcomes improvements in elderly patients. Described under the heading A1C and FBG outcomes visual full text.](https://pro.boehringer-ingelheim.com/ca/products/trajenta/images/new-images/down-arrow.png)
-0.64%
(p<0.0001)
95% CI: -0.81 to -0.48
FBG reduction vs. placebo after 24 weeks1*
![A visual of 2 downward arrows displaying demonstrated A1C and FBG outcomes improvements in elderly patients. Described under the heading A1C and FBG outcomes visual full text.](https://pro.boehringer-ingelheim.com/ca/products/trajenta/images/new-images/down-arrow.png)
-1.15 mmol/L
(p<0.0001)
95% CI: -1.7 to -0.62
-
Mean baseline A1C: 7.8%.
Adapted from Trajenta® Product Monograph.
24-week, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of Trajenta® versus placebo in elderly patients aged ≥70 years (N=241) with T2DM. Patients received Trajenta® 5 mg OD (n=162) or placebo (n=79).
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