Boehringer Ingelheim

 

Trajenta Duo®

(Linagliptin / metformin)

 

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Single-pill combination of linagliptin and metformin for effective glycaemic control in India

Start Simple. Stay Simple.

Discover our single-pill combination of linagliptin and metformin.

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Simple, effective DPP4i for every day glycaemic control

Simple. Effective. Every day

When a DPP4i is needed, choose the Simplicity of Trajenta®.

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Infographics on clinical development of Trajenta – 10 years of Simplicity

10 Years of Simplicity

Browse through two infographics showcasing the clinical development and significant accomplishments for Trajenta®.

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Powerful HbA1c reduction in kidney-impaired Indian T2D patients

Start Simple. Stay Simple.¹

Trajenta Duo® is a single-pill combination of linagliptin and metformin that is available in multiple metformin strengths for dosing flexibility. For drug naive T2DM patients, you can start with Trajenta Duo® for powerful HbA1c reduction¹,³ and then transition to the same dose of linagliptin, with Trajenta®, if kidney function declines further and metformin is no longer recommended.

Powerful HbA1c Reduction.3

Measuring HbA1c is the gold standard for observing and treating patients with type 2 diabetes. In a phase III trial that included metformin-uncontrolled patients with a high HbA1c baseline, linagliptin 2.5mg BID + metformin 1,000mg BID resulted in a reduction* of 1.7% in HbA1c, significantly greater than the 1.2% reduction in patients only taking metformin. Efficacy. Proven.1,2

Proven efficacy in treating T2D patients, Trajenta Duo for glycaemic control

 Placebo-adjusted mean HbA1c change from baseline at 24 weeks*,3

Linagliptin long-term safety, CV and kidney safety proven by a comprehensive CVOT program

Linagliptin Inside

The long-term CV and kidney safety profile of linagliptin has been demonstrated through one of the most comprehensive CVOT programs among DPP4i.8,9 To learn more about the safety of linagliptin, please visit the Trajenta® (linagliptin monotherapy) section of the BI website.

Review the CVOT program

START and STAY with Linagliptin†

Linagliptin is the only globally-available DPP4i that does not require dose reduction based on kidney function.‡,1-2,4-7 With linagliptin, you can start simple with Trajenta Duo® 2.5mg BID and, when appropriate, continue with Trajenta® 5mg QD (once-daily), or the same total daily dose of linagliptin. Start simple, stay simple. Always. Regardless of kidney function.

Start and stay simple with Trajenta Duo

Adverse Events

Trajenta Duo® has an established safety and tolerability profile.² The risk of hypoglycaemia with linagliptin alone (Trajenta®) or with
linagliptin + metformin (Trajenta Duo®) is low and the incidence was comparable to placebo. The adverse drug reactions for linagliptin + metformin as described in the Indian PI are provided in the table below.

 

Adverse reactions by treatment regimen

Adverse reaction information on Trajenta Duo for Indian HCP

Very common: ≥1/10, common: ≥1/100 to <1/10, uncommon: ≥1/1,000 to <1/100, rare: ≥1/10,000 to <1/1,000, very rare: <1/10,000 or not known: cannot be estimated from the available data.

Footnotes
  •  BID:
     twice daily; CKD: chronic kidney disease; CVOT: cardiovascular outcomes trial; DPP4i: dipeptidyl peptidase-4 inhibitor; GFR: glomerular filtration rate; QD: once daily; SPC: single-pill combination.
  • *
    24-week, double-blind, placebo-controlled, Phase III trial. 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 HbA1c ≥11.0% were not eligible for randomisation and received open-label linagliptin + high-dose metformin. High baseline defined as HbA1c >8.5% to <11.0%.
  • †
    The maximum recommended daily dose of Trajenta Duo® contains 5 mg of linagliptin plus 2,000 mg of metformin hydrochloride.
  • ‡
    Trajenta Duo® must not be used in patients with GFR <45 mL/min due to the active substance metformin. Linagliptin may be continued as a single entity tablet (Trajenta®) at the same total daily dose of 5 mg if metformin is discontinued due to evidence of kidney impairment.
  • a
    Based on post-marketing experience.
  • b
    Based on lipase elevations >3xULN observed in clinical trials.
  • c
    Based on the linagliptin cardiovascular and renal safety study (CARMELINA®).
References
  • 1.
    Trajenta Duo® PI Boehringer Ingelheim Pvt. Ltd. Ver 14 Apr 2020.  
  • 2.
    Trajenta® PI Boehringer Ingelheim Pvt. Ltd. Ver 09 Apr 2020.
  • 3.
    Haak T, et al. Diabetes Obes Metab. 2012;14:565–74.
  • 4.
    Glycomet® India PI version 4th April 2016.
  • 5.
    Janumet® India PI Version 1 2019.
  • 6.
    Kombiglyze® India Version 8 dated 18th October 2016.
  • 7.
    Galvus met® India BSS dated 12 Jan 2017 revised on 19 Nov 2018 based on International BSS dated 28 Nov 2016.
  • 8.
    Rosenstock J, et al. JAMA. 2019;321:69-79.
  • 9.
    Rosenstock J, et al. JAMA. 2019; doi:10.1001/jama.2019.13772.