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

CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: linagliptin
Drug: glimepiride
Drug: linagliptin placebo
Drug: glimepiride placebo

First Posted Date: 2010-11-18

Last Posted Date: 2020-01-07

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 6103

Registration Number: NCT01243424

Locations: 🇺🇸
PMI Health Research Group, Atlanta, Georgia, United States
🇺🇸
North Alabama Research Center, LLC, Athens, Alabama, United States
🇺🇸
Matrix Research Institute, Tustin, California, United States

and more 604 locations

Efficacy and Safety Study of Linagliptin (5 mg Administered Orally Once Daily) Over 24 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: placebo
Drug: Linagliptin

First Posted Date: 2010-10-06

Last Posted Date: 2016-08-25

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 306

Registration Number: NCT01215097

Locations: 🇨🇳
1218.65.86008 Boehringer Ingelheim Investigational Site, Dalian, China
🇨🇳
1218.65.86007 Boehringer Ingelheim Investigational Site, Beijing, China
🇨🇳
1218.65.86011 Boehringer Ingelheim Investigational Site, Chongqing, China

and more 16 locations

Efficacy and Safety Study of Linagliptin (5 mg Administered Orally Once Daily) Over 24 Weeks, in Drug naïve or Previously Treated Type 2 Diabetic Patients With Insufficient Glycaemic Control

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Placebo
Drug: Linagliptin

First Posted Date: 2010-10-05

Last Posted Date: 2016-08-25

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 300

Registration Number: NCT01214239

Locations: 🇵🇭
1218.66.63001 Boehringer Ingelheim Investigational Site, Marikina, Philippines
🇵🇭
1218.66.63002 Boehringer Ingelheim Investigational Site, San Juan, Philippines
🇨🇳
1218.66.86007 Boehringer Ingelheim Investigational Site, Beijing, China

and more 16 locations

Comprehensive Add on Study in Japan

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Linagliptin
Drug: Metformin

First Posted Date: 2010-09-17

Last Posted Date: 2014-03-28

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 574

Registration Number: NCT01204294

Locations: 🇯🇵
1218.78.037 Boehringer Ingelheim Investigational Site, Higashi Osaka, Osaka, Japan
🇯🇵
1218.78.026 Boehringer Ingelheim Investigational Site, Kasugai, Aichi, Japan
🇯🇵
1218.78.038 Boehringer Ingelheim Investigational Site, Kawachinagano, Osaka, Japan

and more 40 locations

Efficacy and Safety of Linagliptin (BI 1356) in Black/African Americans With Type 2 Diabetes With a MTT Sub-study

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Linagliptin
Drug: Placebo

First Posted Date: 2010-09-03

Last Posted Date: 2014-01-29

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 234

Registration Number: NCT01194830

Locations: 🇺🇸
1218.75.053 Boehringer Ingelheim Investigational Site, Dallas, Texas, United States
🇺🇸
1218.75.102 Boehringer Ingelheim Investigational Site, Tomball, Texas, United States
🇺🇸
1218.75.037 Boehringer Ingelheim Investigational Site, Philadelphia, Pennsylvania, United States

and more 90 locations

Safety and Efficacy of Linagliptin in Type-2-diabetes Mellitus Patients With Moderate to Severe Renal Impairment

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Placebo
Drug: Glimepiride
Drug: Linagliptin

First Posted Date: 2010-03-16

Last Posted Date: 2014-06-27

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 241

Registration Number: NCT01087502

Locations: 🇦🇺
1218.64.61002 Boehringer Ingelheim Investigational Site, St Leonards, New South Wales, Australia
🇨🇦
1218.64.20007 Boehringer Ingelheim Investigational Site, Hamilton, Ontario, Canada
🇨🇦
1218.64.20008 Boehringer Ingelheim Investigational Site, Corunna, Ontario, Canada

and more 49 locations

Efficacy and Safety of Linagliptin in Elderly Patients With Type 2 Diabetes

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: placebo
Drug: linagliptin

First Posted Date: 2010-03-10

Last Posted Date: 2014-01-29

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 241

Registration Number: NCT01084005

Locations: 🇩🇰
1218.63.45007 Boehringer Ingelheim Investigational Site, Aalborg, Denmark
🇩🇰
1218.63.45003 Boehringer Ingelheim Investigational Site, Aarhus C, Denmark
🇩🇰
1218.63.45001 Boehringer Ingelheim Investigational Site, Birkerød, Denmark

and more 31 locations

Linagliptin Versus Placebo in Type 2 Diabetic Patients With Inadequate Glycaemic Control on Metformin in Combination With Pioglitazone

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Placebo
Drug: Linagliptin

First Posted Date: 2009-10-16

Last Posted Date: 2014-03-26

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 278

Registration Number: NCT00996658

Locations: 🇵🇭
1218.61.63004 Boehringer Ingelheim Investigational Site, Cebu City, Philippines
🇵🇭
1218.61.63002 Boehringer Ingelheim Investigational Site, Davao City, Philippines
🇺🇸
1218.61.01042 Boehringer Ingelheim Investigational Site, Paramount, California, United States

and more 49 locations

Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Linagliptin
Drug: Placebo

First Posted Date: 2009-08-07

Last Posted Date: 2013-12-30

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 1263

Registration Number: NCT00954447

Locations: 🇺🇸
1218.36.01005 Boehringer Ingelheim Investigational Site, Statesville, North Carolina, United States
🇦🇷
1218.36.54004 Boehringer Ingelheim Investigational Site, Córdoba, Argentina
🇧🇪
1218.36.32002 Boehringer Ingelheim Investigational Site, Edegem, Belgium

and more 166 locations

A Randomised, db, Placebo-controlled Study of BI 1356 for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients for Whom Treatment With Metformin is Inappropriate

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Linagliptin Placebo
Drug: Linagliptin
Drug: Glimepiride

First Posted Date: 2008-08-22

Last Posted Date: 2014-06-27

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 227

Registration Number: NCT00740051

Locations: 🇺🇸
1218.50.10011 Boehringer Ingelheim Investigational Site, Peoria, Arizona, United States
🇺🇸
1218.50.10002 Boehringer Ingelheim Investigational Site, Eugene, Oregon, United States
🇵🇭
1218.50.63007 Boehringer Ingelheim Investigational Site, Pasay, Philippines

and more 50 locations

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