Linagliptin

Generic Name: Linagliptin

Brand Names: Glyxambi, Jentadueto, Tradjenta, Trajenta, Trijardy

Drug Type: Small Molecule

Chemical Formula: C_₂₅H_₂₈N_₈O_₂

CAS Number: 668270-12-0

Unique Ingredient Identifier: 3X29ZEJ4R2

Background: Linagliptin is a DPP-4 inhibitor developed by Boehringer Ingelheim for the treatment of type II diabetes . Linagliptin differs from other DPP-4 inhibitors in that it has a non-linear pharmacokinetic profile, is not primarily eliminated by the renal system, and obeys concentration dependant protein binding. Linagliptin was approved by the FDA on May 2, 2011.

Indication: Linagliptin is indicated for the treatment of type II diabetes in addition to diet and exercise. It should not be used to treat type I diabetes or in diabetic ketoacidosis. An extended-release combination product containing empagliflozin, linagliptin, and metformin was approved by the FDA in January 2020 for the improvement of glycemic control in adults with type 2 diabetes mellitus when used adjunctively with diet and exercise.

Associated Conditions: Type 2 Diabetes Mellitus

Clinical Trials

Bioavailability of Combination Tablet BI 1356/Metformin Compared With Single BI 1356 and Metformin Administered Together to Healthy Male and Female Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: BI 1356
Drug: BI 1356/metformin
Drug: Metformin

First Posted Date: 2014-06-25

Last Posted Date: 2014-07-08

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 20

Registration Number: NCT02173639

Relative Bioavailability of BI 10773 and Linagliptin in Healthy Male Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: BI 10773
Drug: Linagliptin

First Posted Date: 2014-06-24

Last Posted Date: 2014-06-24

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 16

Registration Number: NCT02172222

Ascertainment of EMR-based Clinical Covariates Among Patients Receiving Oral and Non-insulin Injected Hypoglycemic Therapy

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: linagliptin

First Posted Date: 2014-05-16

Last Posted Date: 2017-02-08

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 166613

Registration Number: NCT02140645

Locations: 🇺🇸
Boehringer Ingelheim Investigational Site, Boston, Massachusetts, United States

Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/750mg) Extended Release in Healthy Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Linagliptin
Drug: Linagliptin/Metformin ER FDC
Drug: Metformin ER

First Posted Date: 2014-04-23

Last Posted Date: 2016-08-04

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 74

Registration Number: NCT02121509

Locations: 🇩🇪
1288.10.1 Boehringer Ingelheim Investigational Site, Ingelheim, Germany

Renal Effects of DPP-4 Inhibitor Linagliptin in Type 2 Diabetes

Phase 4

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Glimepiride 1 mg QD (N=24)
Drug: Linagliptin 5 mg QD (N=24)

First Posted Date: 2014-04-08

Last Posted Date: 2016-05-17

Lead Sponsor: Amsterdam UMC, location VUmc

Target Recruit Count: 48

Registration Number: NCT02106104

Locations: 🇳🇱
VU University Medical Center, Amsterdam, Netherlands

Effect of Linagliptin on Insulin Sensitivity and Pancreatic Beta Cell Function in Patients With Type 2 Diabetes Mellitus

Phase 4

Conditions: Type 2 Diabetes Mellitus
Insulin Sensitivity/Resistance

Interventions: Drug: Placebo
Drug: Voglibose
Drug: Linagliptin

First Posted Date: 2014-03-27

Last Posted Date: 2014-04-08

Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Target Recruit Count: 30

Registration Number: NCT02097342

Locations: 🇮🇳
Postgraduate Institute of Medical Education & Research, Chandigarh, India

Safety Evaluation of Adverse Reactions in Diabetes

Phase 4

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Linagliptin
Drug: Exenatide
Drug: Gliclazide

First Posted Date: 2014-03-20

Last Posted Date: 2018-02-07

Lead Sponsor: Charles University, Czech Republic

Target Recruit Count: 42

Registration Number: NCT02092597

Locations: 🇨🇿
General University Hospital, Prague, Czechia

Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/1000mg) Extended Release in Healthy Subjects.

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Linagliptin
Drug: Metformin
Drug: Linagliptin/Metformin FDC

First Posted Date: 2014-03-11

Last Posted Date: 2016-08-04

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 74

Registration Number: NCT02084056

Locations: 🇩🇪
1288.11.1 Boehringer Ingelheim Investigational Site, Biberach, Germany

Bioequivalence of a FDC Tablet of Linagliptin/Metformin (5mg/1000mg) Extended Release in Healthy Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Linagliptin/Metformin ER FDC
Drug: Linagliptin
Drug: Metformin ER

First Posted Date: 2014-03-11

Last Posted Date: 2016-08-04

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 68

Registration Number: NCT02084082

Locations: 🇩🇪
1288.9.1 Boehringer Ingelheim Investigational Site, Biberach, Germany

Effect of Linagliptin on Vascular Inflammation in Patients With Type 2 Diabetes Mellitus

Phase 3

Terminated

Conditions: Diabetes Mellitus Type 2 (T2DM)
Vascular Inflammation
Plaque Morphology

Interventions: Drug: Placebo
Drug: Linagliptin

First Posted Date: 2014-03-04

Last Posted Date: 2017-04-12

Lead Sponsor: RWTH Aachen University

Target Recruit Count: 4

Registration Number: NCT02077309

Locations: 🇩🇪
Department of Internal Medicine I, University Hospital, Aachen, Germany
🇳🇱
Cardiovascular Research Institute Maastricht (CARIM), Maastricht, Netherlands

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