Trajenta is proven to lower HbA1c in T2DM patients

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Trajenta is a medication used to treat type 2 diabetes by lowering blood sugar levels in adults.

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Effective HbA_1c Reduction.^3,4

Simplicity means relying on a DPP4i with proven efficacy. Trajenta® consistently lowers HbA_1c for a broad range of T2D patients. Pooled analysis of data from more than 2,200 subjects in three 24-week phase III, randomised, placebo-controlled studies shows that Trajenta® drives a placebo-corrected reduction of 0.8% in HbA_1c(1.2% reduction with Trajenta® compared to 0.4% reduction with placebo).*^,3 Furthermore, in a phase III trial that included metformin-uncontrolled patients with a high HbA_1c baseline, linagliptin 2.5 mg BID + metformin 1,000 mg BID resulted in a reduction of 1.7% in HbA_1c, significantly greater than the 1.2% reduction in patients only taking metformin.^†,4 Efficacy. Proven.⁷

Learn about Trajenta Duo® (linagliptin + metformin)

Mean HbA1c change in T2D patients with Trajenta in 24 weeks

Consistent with Other DPP4i.⁵

A systematic review^#of 83 RCTs to compare the safety and efficacy of different DPP4i in patients with T2D and inadequate glycaemic control, demonstrated that Trajenta® was on par with the other DPP4i in its ability to effectively reduce HbA_1c levels.⁵ Treatment with Trajenta® showed a weighted mean change in HbA_1c of 0.74%.

(Disclaimer: No head to head trials. Direct comparison of studies should be interpreted with caution due to differences in study design, populations, and methodology.)

Parity with other DPP4i in effectively reducing HbA1c level

Relative treatment effect of DPP4i monotherapy vs placebo in a meta-analysis of 83 RCTs^#,5

Sustained efficacy over time of Trajenta over Glimepiride

Adjusted mean HbA_1c values over 104 weeks^§,6

Sustained Efficacy of Linagliptin vs Glimepiride over 2 years.⁶

Unfortunately, for many patients, diabetes treatment may become a long-term mainstay. It is important to select a treatment that is effective, and one that maintains efficacy over time. In a parallel-group, non-inferiority double-blind trial, Trajenta® showed sustained efficacy up to 104 weeks compared to glimepiride (2 years), with an adjusted mean HbA_1c reduction of 0.6% at 104 weeks.^§,6 Efficacy. Sustained.

Powerful Efficacy in a Wide Range of Patients.**^,7

No two diabetes patients are the same. Whether you are considering Trajenta® as monotherapy or in addition to existing therapy, whether your patient has had T2D for more than 5 years or recently diagnosed, whether your patient has a BMI < 25 or ≥ 35, regardless of age, race, liver or kidney function, Trajenta® has been proven effective at lowering HbA_1c levels, all at a single dose of 5 mg, once daily.**^,7 That is the Simplicity of Trajenta®.

Cardiovascular outcome trial in over 13,000 T2D patients

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Review data from the CVOT program

No dose adjustment of DPP4i required for age, weight, or liver or kidney function"

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BMI:
body mass index; CI: confidence interval; CrI: credible interval; CV: cardiovascular; CVOT: cardiovascular outcome trial; DPP4i: dipeptidyl peptidase-4 inhibitor; RCT: randomized controlled trial; T2D: type 2 diabetes
*
Pooled analysis of data from 2,258 subjects in three 24-week phase III, randomised, placebo-controlled, parallel-group studies, who received oral linagliptin (5 mg/day) or placebo as monotherapy, added-on to metformin, or added-on to metformin plus sulphonylurea was performed³. Adjusted mean HbA_1c was reduced from a baseline level of 9.4% (79 mmol/mol) to 8.3% (67 mmol/mol) in the linagliptin group (n= 287) and 9.1% (76 mmol/mol) in the placebo group (n=101) at 24 weeks (p < 0.0001). Thus, 24-week treatment with linagliptin achieved a −1.2% adjusted mean change from baseline vs. a 0.4% reduction with placebo, giving a treatment difference of 0.8% in favor of linagliptin (95% CI, −1.0 to −0.6). For the monotherapy trial, linagliptin produced a reduction in HbA_1c of 0.9% vs. a 0.2% increase for placebo, resulting in a treatment difference of 1.0% in favor of linagliptin (95% CI, −1.6 to −0.5; p = 0.0005). Corresponding data for the add-on to metformin study were a 0.9% reduction in HbA_1c for linagliptin vs. a 0.3% reduction for placebo, resulting in a treatment difference of −0.7 (95% CI, −1.1 to −0.2; p = 0.0062). In the add-on to metformin plus sulphonylurea trial, the linagliptin group showed a reduction in HbA_1c of 1.3% vs. a 0.6% reduction for placebo, leading to a treatment difference of 0.7% in favor of linagliptin (95% CI, −1.1 to −0.4; p < 0.0001).
†
24-week, double-blind, placebo-controlled, Phase III trial⁴. Two arms received linagliptin 2.5 mg twice daily (BID) + either low (500 mg) or high (1,000 mg) dose metformin BID. Four arms received linagliptin 5 mg once daily, metformin 500 mg or 1,000 mg BID or placebo. Patients with HbA_1c ≥11.0% were not eligible for randomisation and received open-label linagliptin + high-dose metformin. High baseline defined as HbA_1c >8.5% to <11.0%. The placebo-corrected mean (95% CI) change in HbA_1c from baseline (8.7%) to week 24 was −1.7% (−2.0, -1.4) for linagliptin + high-dose metformin, -1.3% (-1.6, -1.1) for linagliptin + low-dose metformin, -1.2% (-1.5, -0.9) for high-dose metformin, -0.8% (-1.0, -0.5) for low-dose metformin and -0.6% (-0.9, -0.3) for linagliptin (all p < 0.0001). In the open-label arm, the mean change in HbA_1c from baseline (11.8%) was -3.7%.
#
A systematic review of RCTs, health economic evaluation studies, systematic reviews, and meta-analyses, followed by primary Bayesian mixed treatment comparison meta-analyses and secondary frequentist direct comparison meta-analyses using a random effects model to compare the safety and efficacy of DPP4i in patients with T2D and inadequate glycaemic control⁵. Outcomes were reported as weighted mean change from baseline, or odds ratio with 95% CrI. The weighted mean HbA_1c change from baseline (95% CrI) for each DPP4i as monotherapy was: for linagliptin, -0.74 (-0.96 to -0.51); for alogliptin, -0.74 (-0.99 to -0.49); for saxagliptin, -0.61 (-0.91 to -0.31); for sitagliptin, -0.75 (-0.90 to -0.60); and for vildagliptin, -0.67 (-0.87 to -0.47).
‡
Statistically significant versus placebo. Overlapping 95% credible intervals were predefined as evidence of no difference between treatments.
§
Study performed using a free combination of linagliptin and metformin. 2 year parallel-group, non-inferiority double-blind trial. Patients receiving stable metformin alone or with one additional oral antidiabetic drug (washed out during screening) were randomly assigned to linagliptin (5 mg) or glimepiride (1–4 mg) orally once daily added to ongoing metformin. At week 104, adjusted mean changes in HbA_1c from a baseline of 7.7% were −0.16% with linagliptin (full analysis set; n=764) and −0.36% with glimepiride (full analysis set; n=755); the difference between treatment groups met the non-inferiority criterion (primary analysis) and was 0.20% (97.5% CI 0.09–0.30; p=0.0004 for non-inferiority; one-sided; non-inferiority margin was 0.35% HbA_1cdifference). In the completers cohort, adjusted mean changes in HbA_1c from a baseline of 7.2% and 7.3% to week 104 were −0.56% with linagliptin (completers cohort; n=233) versus −0.63% with glimepiride (completers cohort; n=271); the treatment difference was 0.08% (95% CI 0.00–0.15; p=0.0468; two-sided; post-hoc).
**
Indicated for use in adult patients. Trajenta® is contraindicated in those with hypersensitivity to any of the active substances or excipients, is not licensed for paediatric use and should not be used in pregnant women.

References

1.
Cooper M, et al. Diabetes Obes Metab. 2020; 1–12.
2.
Kadowaki T, et al. Diabetol Int. 2020. doi.org/10.1007/s13340-020-00447-5.
3.
Del Prato S, et al. J Diab Compl. 2013;27:274–9.
4.
Haak T, et al. Diabetes Obes Metab. 2012;14:565–74.
5.
Craddy P, et al. Diabetes Ther 2014;5:1-41.
6.
Gallwitz B, et al. Lancet. 2012;380:475-83.
7.
Trajenta® PI Boehringer Ingelheim Pvt. Ltd. Ver 09 Apr 2020

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