Explore. Efficacy. | boehringerone.com

Efficacy Overview

This infographic is a comprehensive interactive application that allows you to explore the extensive efficacy data of Linagliptin (Trajenta®) across a broad range of patients with type 2 diabetes.*¹

SEE THE DATA

SEE MORE DATA

Pooled Data from 3
Phase III studies^†2

Mean Baseline
HbA_1C = 9.4% (n=287)

Linagliptin

-0.8%

(p<0.0001)

Adjusted Mean Change in HbA_1C vs placebo, at 24 weeks

SEE MORE DATA

Meta-Analysis of 83 RCTs,^‡3
including 9 RCTs for Linagliptin

Linagliptin

-0.74%

Saxagliptin

-0.61%

Sitagliptin

-0.75%

Vildagliptin

-0.67%

All values shown are statistically significant vs. placebo

* Indicated for use in adult T2D patients. Linagliptin (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.

† 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 performed. Adjusted mean HbA1c change from baseline with linagliptin was -1.2% (vs -0.4% with placebo, p<0.0001): in patients with a baseline HbA1C ≥9.0%.

‡ 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 control. Outcomes were reported as weighted mean change from baseline, or odds ratio with 95% CrI.

CrI: Credible interval; RCT: Randomised controlled trial.

1. Linagliptin (TRAJENTA®) PH Prescribing Information. April 2019.

1. Linagliptin (TRAJENTA®) PH Prescribing Information. April 2019. 2. Del Prato S, et al. J Diab Compl. 2013;27:274-9; 3. Craddy P, et al. Diabetes Ther. 2014;5:1-41.

Efficacy Overview

This infographic is a comprehensive interactive application that allows you to explore the extensive
efficacy data of Linagliptin (Trajenta®) across
a broad range of patients with
type 2 diabetes.*¹

SEE THE DATA

SEE MORE DATA

Pooled Data from 3 Phase III studies^†2

Mean Baseline HbA_1C = 9.4% (n=287)

Linagliptin (Trajenta®)

Adjusted Mean Change in HbA_1C vs placebo, at 24 weeks

-0.8%

(p<0.0001)

SEE MORE DATA

* Indicated for use in adult T2D patients. Linagliptin (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.

† 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 performed. Adjusted mean HbA1c change from baseline with linagliptin was -1.2% (vs -0.4% with placebo, p<0.0001): in patients with a baseline HbA1C ≥9.0%.

‡ 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 control. Outcomes were reported as weighted mean change from baseline, or odds ratio with 95% CrI.

CrI: Credible interval; RCT: Randomised controlled trial.

1. Linagliptin (TRAJENTA®) PH Prescribing Information. April 2019. 2. Del Prato S, et al. J Diab Compl. 2013;27:274-9; 3. Craddy P, et al. Diabetes Ther. 2014;5:1-41.

1. Linagliptin (TRAJENTA®) PH Prescribing Information. April 2019.

Linagliptin (Trajenta®) has consistent efficacy in reducing HbA_1C for T2D patients regardless of

Ethnicity^1-4

SEE THE DATA

Mean Baseline HbA_1C (n)

Mean Baseline
HbA_1C (n)

8.0%
(333)

8.6%
(98)

8.0%
(200)

8.2%
(478)

Ethnicity

ETHNICITY

WHITE
& ASIAN¹

BLACK*²

ASIAN^†3

HISPANIC^‡4

Adjusted Mean Change in HbA_1C vs placebo, at 24 weeks

Adjusted
Mean Change
in HbA_1C
vs placebo,
at 24 weeks

-0.69%
(p<0.0001)

-0.58%
(p<0.0001)

-0.50%
(p<0.0001)

-0.58%
(p<0.0001)

* 24-week, double-blind, placebo-controlled trial in Black/African American patients with T2D. Model adjusted for treatment, baseline HbA1c and number of oral antidiabetic drugs. FAS (LOCF), excluding patients who received rescue therapy.

† 24-week, placebo-controlled, Phase III study in Asian patients. Patients with HbA1c ≥7.0 to ≤10.0% who were treatment naïve or had been treated with one oral antidiabetic drug were randomised to (2:1) linagliptin 5 mg QD or placebo. Primary end-point was a change from baseline in HbA1c after 24 weeks.

‡ Pooled analysis of 4 randomised, placebo-controlled Phase III trials. Patients received linagliptin 5 mg QD or placebo as monotherapy, or in combination with other oral antidiabetic drugs and self-identified as Hispanic or Latino (FAS; LOCF).

FAS: Full analysis set; LOCF: Last outcome carried forward; QD: Once daily.

Del Prato S, et al. Diabetes Obes Metab. 2011;13:258-67;
Thrasher J, et al. Endocr Pract. 2014;20(5):412-20;
Chen Y, et al. J Diabetes Investig. 2015;6:692-8;
Davidson J, et al. BMJ Open Diabetes Res Care. 2014;2(1):e000020.

Linagliptin (Trajenta®) Efficacy by Ethnicity

Linagliptin (Trajenta®) has consistent efficacy in reducing HbA_1C for adult T2D patients regardless of

Age*¹

SEE THE DATA

* No dose adjustment is necessary based on age.

1. Del Prato S, et al. Nutr Metab Cardiovasc Dis. 2016;26: 886-892.

* No dose adjustment is necessary based on age. Linagliptin (Trajenta®) is indicated for use in adult patients. It is not licensed for paediatric use.

† Pre-specified sub-group analysis on pooled data from 3 pivotal Phase III, randomised, placebo-controlled trials: treatment in monotherapy, add-on to metformin and add-on to metformin plus sulphonylurea. p-values for between-group differences (vs placebo).

‡ ANCOVA adjusted for continuous HbA_1C, BMI group, washout phase, treatment group, study, age group, sex, time since diagnosis of diabetes, race and age × treatment or type 2 diabetes × treatment interactions.

BMI: Body mass index.

1. Del Prato S, et al. Nutr Metab Cardiovasc Dis. 2016;26: 886-892.

Linagliptin (Trajenta®) has consistent efficacy in reducing HbA_1C for T2D patients regardless of

Gender¹

SEE THE DATA

* Pre-specified sub-group analysis on pooled data from 3 pivotal Phase III, randomised, placebo-controlled trials: treatment in monotherapy, add-on to metformin and add-on to metformin plus sulphonylurea. p-values for between-group differences (vs placebo).

† ANCOVA adjusted for continuous HbA_1C, BMI group, washout phase, treatment group, study, age group, sex, time since diagnosis of diabetes, race and age × treatment or type 2 diabetes × treatment interactions.

BMI: Body mass index.

1. Del Prato S, et al. Nutr Metab Cardiovasc Dis. 2016;26:886-892.

Linagliptin (Trajenta®) Efficacy by Gender

Linagliptin (Trajenta®) has consistent efficacy in reducing HbA_1C for T2D patients regardless of

BMI¹

SEE THE DATA

* HbA_1C adjustments were analysed for covariance by the ANCOVA model by treatment, continuous baseline HbA_1C, subgroup by treatment interaction; for analysis of baseline HbA_1C subgroups, the term for continuous baseline HbA_1C was replaced by categorical HbA_1C.

† Metformin was up-titrated in the first 6 weeks to a maximal dose of 2,000 mg/day.

PPCC = All randomised patients who received ≥1 dose of study drug, had a baseline HbA_1C measurement, had no important protocol violations, completed 24 weeks of treatment without receiving glycaemic rescue, and had an HbA_1C measurement at Week 24.

BMI: Body mass index; PPCC: Per-protocol completers cohort.

1. Ross S, et al. Postgrad Med. 2016;128(8):747-754.

Linagliptin (Trajenta®) is the DPP4i with the lowest kidney excretion rate. It has consistent efficacy in reducing HbA_1C for T2D patients regardless of

Kidney
Function^1-3

SEE THE DATA

* Prespecified subgroup analysis on pooled data from three pivotal Phase III, randomised, placebo-controlled trials: treatment in monotherapy, add-on to metformin, and add-on to metformin plus sulphonylurea. P values for between-group difference (versus placebo). Model includes continuous baseline HbA_1C, baseline body mass index (category), washout period, treatment, study, age group, gender, time since diagnosis of diabetes, race, kidney function (MDRD), and treatment by kidney function (MDRD). Measurements shown at 24 weeks.

† 1-year, randomised, double-blind, placebo-controlled study: treatment added to existing background therapy. Data based on analysis using LOCF.

eGFR: Estimated glomerular filtration rate; LOCF: Last outcome carried forward; MDRD: Modification of Diet in Renal Disease; QD: Once daily; RCT: Randomised controlled trial; Scr: Serum creatinine.

1. Groop P, et al. Diabetes Obes Metab. 2014;16:560-8; 2. McGill J, et al. Diabetes Care. 2013;36:237-44; 3. Linagliptin (TRAJENTA®) PH Prescribing Information. April 2019.

1. Groop P, et al. Diabetes Obes Metab. 2014;16:560-8;

2. McGill J, et al. Diabetes Care. 2013;36:237-44;

3. Linagliptin (TRAJENTA®) PH Prescribing Information. April 2019.

Linagliptin (Trajenta®) Efficacy by Kidney Function

Linagliptin (Trajenta®) Efficacy by Hepatic Function

Linagliptin (Trajenta®) has consistent efficacy in reducing HbA_1C for T2D patients regardless of

Hepatic
Function¹

SEE THE DATA

* Pooled analysis of 17 trials with study duration ≥24 weeks; FAS (LOCF), all participants who had a baseline and at least one on-treatment HbA_1C measurement.

† ANCOVA model includes treatment, study, baseline HbA_1C, prior oral antidiabetic drugs, hepatobiliary disorders, and hepatobiliary disorders x treatment interaction. P value of interaction between treatment and hepatobiliary disorder is >0.05.

‡ Hepatobiliary disorders included: hepatic steatosis, cholelithiasis, cholecystitis, liver disorder, hepatomegaly, gallbladder polyp and chronic hepatitis.

# Adjusted mean changed in HbA_1C vs placebo at 24 weeks for patients with hepatobiliary disorders was -0.54% [95% CI -0.72, -0.36] and for patients without hepatobiliary disorders was -0.62% [95% CI -0.67, -0.57].

CI: Confidence interval; FAS: Full analysis set.

1. Inagaki N, et al. J Diabetes Complications. 2016;30(8):1622-1630.

Whether your patient is recently diagnosed, or has had T2D for many years, Linagliptin (Trajenta®) has consistent efficacy in reducing HbA_1C for T2D patients regardless of

Disease
Duration^1-2

SEE THE DATA

* Pre-specified sub-group analysis on pooled data from 3 pivotal Phase III, randomised, placebo-controlled trials: treatment in monotherapy, add-on to metformin and add-on to metformin plus sulphonylurea. p-values for between-group differences (vs placebo).

† ANCOVA adjusted for continuous HbA_1C, BMI group, washout phase, treatment group, study, age group, sex, time since diagnosis of diabetes, race and age × treatment or type 2 diabetes × treatment interactions.

‡ Pooled analysis from two Phase III, randomised, trials in patients with T2D for >10 years receiving either linagliptin 5 mg QD or placebo for 24 weeks as add-on to their current glucose-lowering therapy (FAS; LOCF). Adjusted mean change in HbA_1C vs placebo of -0.66% [95% CI -0.95, -0.38].

BMI: Body mass index; CI: Confidence interval; FAS: Full analysis set; LOCF: Last outcome carried forward; QD: Once daily.

Del Prato S, et al. Nutr Metab Cardiovasc Dis. 2016;26:886-892.
Lajara R et al. Clin Ther 2014;36:1595.

Linagliptin (Trajenta®) Efficacy by Disease Duration

Linagliptin (Trajenta®) Efficacy by Background Therapy

Linagliptin (Trajenta®) has consistent efficacy in reducing HbA_1C for T2D patients regardless of

T2D Background
Therapy^1-5

SEE THE DATA

1. Del Prato S, et al. Diabetes Obes Metab. 2011;13:258-67;
2. Taskinen M, et al. Diabetes Obes Metab. 2011;13:65-74;
3. Owens D, et al. Diabetic Med. 2011;28:1352-61;
4. Gomis R, et al. Diabetes Obes Metab. 2011;13:653-61;
5. Yki-Järvinen H, et al. Diabetes Care. 2013;36:3875-81.

Met: Metformin; Pio: Pioglitazone; SU: Sulphonylurea.
1. Del Prato S, et al. Diabetes Obes Metab. 2011;13:258-67; 2. Taskinen M, et al. Diabetes Obes Metab. 2011;13:65-74; 3. Owens D, et al. Diabetic Med. 2011;28:1352-61; 4. Gomis R, et al. Diabetes Obes Metab. 2011;13:653-61; 5. Yki-Järvinen H, et al. Diabetes Care. 2013;36:3875-81.

1. Del Prato S, et al. Diabetes Obes Metab. 2011;13:258-67;

2. Taskinen M, et al. Diabetes Obes Metab. 2011;13:65-74;

3. Owens D, et al. Diabetic Med. 2011;28:1352-61;

4. Gomis R, et al. Diabetes Obes Metab. 2011;13:653-61;

5. Yki-Järvinen H, et al. Diabetes Care. 2013;36:3875-81.

Met: Metformin; Pio: Pioglitazone; SU: Sulphonylurea.

1. Del Prato S, et al. Diabetes Obes Metab. 2011;13:258-67;

2. Taskinen M, et al. Diabetes Obes Metab. 2011;13:65-74;

3. Owens D, et al. Diabetic Med. 2011;28:1352-61;

4. Gomis R, et al. Diabetes Obes Metab. 2011;13:653-61;

5. Yki-Järvinen H, et al. Diabetes Care. 2013;36:3875-81.

Simplicity means...

Relying on a DPP4i with consistent efficacy

When you decide to use a DPP4i to lower HbA_1C, you should rely on one with proven efficacy. Linagliptin (Trajenta®) consistently lowers HbA_1C for a broad range of T2D patients, and does so at a single 5 mg dose, once daily¹.

1. Linagliptin (TRAJENTA®) PH Prescribing Information. April 2019.

Boehringer Ingelheim (Philippines), Inc.
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8741 Paseo de Roxas, Bel-Air,
Makati City, Metro Manila
Phone +(632) 8867-0880
Email to us:
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RIN Number: PC-PH-103187
Production Date: January 2024