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TRAJENTA®
Linagliptin
Efficacy
Clinical trials demonstrate that TRAJENTA® significantly improves glycaemic control1,2 regardless of renal function,2,3 or patient age.5
In phase III clinical trials, TRAJENTA® produced clinically significant improvements in glycaemic control.1,2
Adapted from: 1. Del Prato S, et al. J Diab Compl. 2013 2. Cooper M, et al. Poster presented at ADA 2011.
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%).1
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.2
In randomised controlled trials (including three phase III trials), TRAJENTA® produced clinically significant improvements in glycaemic control regardless of renal function.2,3
Adapted from: 2. Cooper M, Poster presented at ADA 2011 3. McGill JB, et al. Diabetes Care. 2013 4. TRAJENTA® SmPC.
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.2
McGill: 1-year randomised, double blind, placebo-controlled study where treatment was added to existing background therapy. 133 patients (mean age 64.4 years) had severe renal impairment (eGFR <30 ml/min /1.73 m2), an HbA1c of >7 and <10% and a BMI ≤45 kg/m2. 63.9% and 18% of the overall study population were treated with insulin alone and insulin combination respectively. Background therapy was fixed for the first 12 weeks. Between weeks 12–52, therapy could be adjusted according to glucose parameters. Primary endpoint: Change in HbA1c from baseline after 12 weeks.3
In phase III clinical trials, TRAJENTA® produced clinically significant improvements in glycaemic control regardless of patient age.5
Adapted from: 5. Patel S, et al. European Association for the Study of Diabetes 2011, Poster P832
Patel: Pre–specified subgroup analysis on pooled data from three phase III, randomised, placebo–controlled trials: treatment in monotherapy, add-on to metformin, and add–on to metformin plus sulphonylurea. Primary endpoint: Change in HbA1c from baseline after 24 weeks (in all three studies).5
Footnotes
- *CrCl = (140 - age) x body weight)/(72 x Scr), x 0.85 for females.
- †eGFR (mL/min/1.73m2) = 175 x (Scr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.212 if Black).
- ‡ANCOVA-adjusted for continuous HbA1c, BMI group, washout phase, treatment group, study, age group, sex, time since diagnosis of diabetes, race and age x treatment or type 2 diabetes x treatment interactions.
- #p–values for between-group differences (vs. placebo).
Robust clinical trials with thousands of patients
Demonstrated safety profile
TRAJENTA® selectively inhibits DPP-4
References
- Del Prato S, et al. J Diab Compl. 2013;27:274–9.
- 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.
- McGill JB, et al. Diabetes Care. 2013;36:237-44.
- TRAJENTA® (linagliptin) Summary of Product Characteristics. SmPCs available at EMC: www.medicines.org.uk (GB) and https://www.emcmedicines.com/en-GB/northernireland/ (NI).
- Patel S, et al. European Association for the Study of Diabetes 2011, 12-16 September 2011, Lisbon, Portugal; Poster P832.
PC-GB-105688 V2
September 2022