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TRAJENTA® (linagliptin) is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control as:1

  • monotherapy when metformin is inappropriate due to intolerance, or contraindicated due to renal impairment
  • combination therapy with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control

(see SmPC for available data on different combinations).

Mechanism of action

TRAJENTA is an inhibitor of the enzyme DPP-4, an enzyme which is involved in the inactivation of the incretin hormones GLP-1 and GIP (glucagon-like peptide-1, glucose-dependent insulinotropic polypeptide). These hormones are rapidly degraded by the enzyme DPP-4. Both incretin hormones are involved in the physiological regulation of glucose homeostasis.1 TRAJENTA selectively inhibits the enzyme DPP-4, which leads to a glucose-dependent increase in insulin secretion and a reduction in glucagon secretion thus resulting in an overall improvement in glucose homeostasis.1 DPP-4 inhibitors prolong the action of incretins (GLP-1 and GIP), by working in a glucose-dependent way.2,3

TRAJENTA is excreted primarily via the bile and only 5% through the kidney. TRAJENTA can therefore be used at any stage of renal function1


In phase III clinical trials, TRAJENTA produced clinically significant improvements in glycaemic control with no clinically relevant change in body weight.4,5

Study Designs

Del Prato: Pooled analysis of data from 2,258 subjects in three 24-week phase III, randomised, placebo-controlled, parallel-group studies, who received oral TRAJENTA (5 mg/day) or placebo as monotherapy, added-on to metformin, or added-on to metformin plus sulphonylurea was performed. Results shown are from 388 patients who had a high mean baseline HbA1c of 79.2 mmol/mol/ 9.4%.4

Cooper: Pooled analysis of individual patient data from three placebo-controlled trials (n = 2,141) based on creatinine clearance rates at baseline: normal, ≥80 ml/min; mild, 50 – <80 ml/min; moderate, 30 – <50 ml/min). For each renal function group, the change from baseline HbA1c was compared between TRAJENTA (5 mg) and placebo. The treatment effect of TRAJENTA was then compared among the three renal function groups. Results shown are from 1,684 patients with normal renal function.5


The recommended dose of TRAJENTA is 5 mg once daily.

When TRAJENTA is added to metformin, the dose of metformin should be maintained, and linagliptin administered concomitantly. When linagliptin is used in combination with a sulphonylurea or with insulin, a lower dose of sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia.

TRAJENTA does not require dose adjustment based on a patient’s renal function. It is important to ensure that patients are treated according to the licensed indications of a drug, including dose recommendations, and in line with clinical guidance including the NICE guidelines on the management of type 2 diabetes and chronic kidney disease (NG28 and CG182).1,6–9

Cardiovascular and renal safety profile

CARMELINA® and CAROLINA® constitute a robust cardiovascular outcome trial (CVOT) programme assessing the CV safety profile of TRAJENTA in a broad range of adult T2D patients.10,11

The CARMELINA® (CArdiovascular safety and Renal Microvascular outcomE with LINAgliptin in patients with type 2 diabetes at high vascular risk) CVOT investigated the CV and kidney safety profile of linagliptin versus placebo, on top of standard of care10*

CARMELINA® confirmed the overall safety profile of TRAJENTA in patients with T2D, including those with heart and/or kidney disease and is the first DPP-4 inhibitor CVOT that included pre-specified and adjudicated kidney endpoints to assess kidney safety profile.10,13-16 The trial also adds evidence to the clinical safety profile of linagliptin by including patients at advanced stages of kidney disease10

The CAROLINA® (CARrdiovascular Outcome study of LINAgliptin versus glimepiride) CVOT assessed the impact of linagliptin 5 mg/day or glimepiride 1-4 mg/day, on top of standard of care, on CV outcomes and glycaemic risk in patients with T2D11

CAROLINA, the longest DPP-4 inhibitor CVOT to date, confirmed the long-term CV safety profile of TRAJENTA relative to glimepiride in patients with relatively early T2D at increased CV risk11

In CAROLINA, TRAJENTA demonstrated a lower risk of hypoglycaemia (vs. glimepiride). Incidence of hypoglycaemic events was lower across all predefined hypoglycaemia-severity categories11

*Patients received additional glucose-lowering therapy and were treated for CV risk factors in accordance with local or regional standards of care.
†Trial durations: CARMELINA for 2.2 years and CAROLINA for 6.3 years


The most frequently reported adverse reaction was hypoglycaemia when TRAJENTA was used in combination with metformin and sulphonylurea. TRAJENTA alone had a comparable incidence of hypoglycaemia to placebo.1

Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, TRAJENTA should be discontinued; if acute pancreatitis is confirmed, TRAJENTA should not be restarted. Caution should be exercised in patients with a history of pancreatitis.1

Bullous pemphigoid has been observed in patients taking linagliptin. If bullous pemphigoid is suspected, TRAJENTA should be discontinued.1

Studies suggest that no dose adjustment is required for patients with hepatic impairment but clinical experience in such patients is lacking.1

Avoid use during pregnancy; a risk to the breast-fed child cannot be excluded.1

Refer to the SmPC for adverse effects and contraindications.1


1.    TRAJENTA (linagliptin) Summary of Product Characteristics.
2.    Drucker DJ. Expert Opin Invest Drugs 2003;12:87-100.
3.    Ahrén B. Curr Diab Rep 2003;3:365-372.
4.    Del Prato S, et al. J Diab Compl. 2013;27:274–9.
5.    Cooper M, et al. Poster No. 1068-P. The 71st Scientific Sessions of the American
Diabetes Association, 24–28 June 2011, San Diego, CA, USA.
6.    Sitagliptin Summary of Product Characteristics.
7.    Vildagliptin Summary of Product Characteristics.
8.    Saxagliptin Summary of Product Characteristics.
9.    Alogliptin Summary of Product Characteristics.
10.   Rosenstock J et al. JAMA 2019;321(1):69.
11.   Rosenstock J, et al. JAMA. 2019;322(12):1155-1166.
12.   McGill JB, et al. Diabetes Care. 2013;36:237-44.
13.   Rosenstock J et al. Cardiovasc Diabetol 2018;17:39.
14.   Scirica BM et al. N Engl J Med 2013;369:1317.
15.   White WB et al. N Engl J Med 2013;369:1327.
16.   Engel SE et al. Diabetes Obes Metab 2017;19:1587.

Prescribing Information and Adverse events reporting for TRAJENTA can be accessed here:

PC-GB-101601 April 2020