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...

Associated Conditions: Type 2 Diabetes Mellitus

Associated Therapies: -

Clinical Trials

A Comparison of Two Treatment Strategies in Older Participants With Type 2 Diabetes Mellitus (T2DM)

Phase 4

Terminated

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Metformin
Drug: Glimepiride
Drug: Pioglitazone
Drug: Acarbose
Drug: Linagliptin
Drug: Sitagliptin
Drug: Liraglutide
Drug: Exenatide once weekly (QW)
Drug: Insulin Glargine
Drug: Exenatide twice daily (BID)

First Posted Date: 2014-02-26

Last Posted Date: 2019-10-09

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 192

Registration Number: NCT02072096

Locations: 🇺🇸
Rocky Mountain Diabetes and Osteoporosis Center, Idaho Falls, Idaho, United States
🇺🇸
Southern New Hampshire Diabetes and Endocrinology, Nashua, New Hampshire, United States
🇺🇸
Carolina Health Specialists, Myrtle Beach, South Carolina, United States

and more 16 locations

ADA Linagliptin in Long Term Care

Phase 4

Completed

Conditions: Diabetes

Interventions: Drug: insulin glargine
Drug: linagliptin

First Posted Date: 2014-02-13

Last Posted Date: 2018-08-22

Lead Sponsor: Emory University

Target Recruit Count: 140

Registration Number: NCT02061969

Locations: 🇺🇸
Wesley Woods Nursing Home, Atlanta, Georgia, United States
🇺🇸
VA Nursing Home, Decatur, Georgia, United States
🇺🇸
Budd Terrace Nursing Home, Atlanta, Georgia, United States

and more 1 locations

Off taRget Effects of Linagliptin monothErapy on Arterial Stiffness in Early Diabetes

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Linagliptin
Drug: placebo

First Posted Date: 2013-12-19

Last Posted Date: 2016-05-18

Lead Sponsor: dr. DJ Mulder

Target Recruit Count: 45

Registration Number: NCT02015299

Locations: 🇳🇱
University Medical Center Groningen, Groningen, Netherlands

Linagliptin Inpatient Trial

Phase 4

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Basal Bolus
Drug: Linagliptin + 50% Glargine dose on discharge
Drug: Linagliptin + 80% Glargine
Drug: Linagliptin

First Posted Date: 2013-12-09

Last Posted Date: 2019-02-20

Lead Sponsor: Emory University

Target Recruit Count: 295

Registration Number: NCT02004366

Locations: 🇺🇸
Boston Medical Center, Boston, Massachusetts, United States
🇺🇸
Grady Memorial Hospital, Atlanta, Georgia, United States
🇺🇸
Rush University Medical Center, Chicago, Illinois, United States

and more 2 locations

The Effect of Linagliptin on Mitochondrial and Endothelial Function

Phase 4

Completed

Conditions: Type II Diabetes Mellitus

Interventions: Drug: Placebo
Drug: Linagliptin
Other: Microcirculation testing
Other: Macrocirculation testing
Other: MRI Scans

First Posted Date: 2013-10-25

Last Posted Date: 2016-11-18

Lead Sponsor: Beth Israel Deaconess Medical Center

Target Recruit Count: 45

Registration Number: NCT01969084

Locations: 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Two-way Crossover Study in Healthy Male and Female Subjects to Evaluate the Bioequivalence of Jentadueto®.

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Metformin
Drug: Linagliptin

First Posted Date: 2013-09-20

Last Posted Date: 2015-02-25

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 36

Registration Number: NCT01947153

Locations: 🇷🇺
1288.21.1 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation

Linagliptin in Schizophrenia Patients

Phase 1

Terminated

Conditions: Schizophrenia

Interventions: Drug: Linagliptin

First Posted Date: 2013-09-16

Last Posted Date: 2018-08-16

Lead Sponsor: Monash University

Target Recruit Count: 1

Registration Number: NCT01943019

Locations: 🇲🇾
Pusat Perubatan Universiti Kebangsaan Malaysia, Bandar Tun Razak, Kuala Lumpur, Malaysia

Effects of Linagliptin on Active GLP-1 Concentrations in Subjects With Renal Impairment

Phase 4

Completed

Conditions: Diabetes Mellitus

Interventions: Drug: Linagliptin

First Posted Date: 2013-07-19

Last Posted Date: 2017-03-03

Lead Sponsor: Profil Institut für Stoffwechselforschung GmbH

Target Recruit Count: 99

Registration Number: NCT01903070

Locations: 🇩🇪
Profil Institut für Stoffwechselforschung GmbH, Neuss, NRW, Germany

Cardiovascular and Renal Microvascular Outcome Study With Linagliptin in Patients With Type 2 Diabetes Mellitus (CARMELINA)

Phase 4

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Placebo
Drug: Linagliptin

First Posted Date: 2013-07-12

Last Posted Date: 2019-04-04

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 6991

Registration Number: NCT01897532

Locations: 🇺🇸
DM Clinical Research, Tomball, Texas, United States
🇺🇸
Pioneer Research Solutions, Inc., Sugar Land, Texas, United States
🇦🇷
Prevencion Cardiovascular Salta, Salta, Salta, Argentina

and more 633 locations

Diastolic Dysfunction in Patients With Type 2 Diabetes Mellitus

Phase 3

Terminated

Conditions: Diabetes Mellitus Type 2 (T2DM)
Left Ventricular Diastolic Dysfunction

Interventions: Drug: placebo
Drug: Linagliptin

First Posted Date: 2013-06-28

Last Posted Date: 2017-04-12

Lead Sponsor: RWTH Aachen University

Target Recruit Count: 8

Registration Number: NCT01888796

Locations: 🇩🇪
Department of Internal Medicine I, University Hospital, Aachen, Germany

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