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

Randomized, Double-blind (db), Placebo-controlled 18 Week Study of Linagliptin (BI 1356) in Type 2 Diabetic Patients With Insufficient Glycaemic Control on a Sulfonylurea Drug

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Placebo
Drug: BI 1356

First Posted Date: 2009-01-08

Last Posted Date: 2014-06-27

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 245

Registration Number: NCT00819091

Locations: 🇮🇳
1218.35.91003 Boehringer Ingelheim Investigational Site, Aligarh, Uttar Pradesh, India
🇮🇳
1218.35.91006 Boehringer Ingelheim Investigational Site, Pune, Maharastra, India
🇵🇱
1218.35.48003 Boehringer Ingelheim Investigational Site, Poznan, Poland

and more 42 locations

Safety and Efficacy in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 (Linagliptin) vs. Placebo, Insulin Background Inclusive

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: BI 1356
Drug: placebo

First Posted Date: 2008-12-02

Last Posted Date: 2014-05-20

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 133

Registration Number: NCT00800683

Locations: 🇺🇸
1218.43.10013 Boehringer Ingelheim Investigational Site, Pembroke Pines, Florida, United States
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1218.43.10009 Boehringer Ingelheim Investigational Site, West Palm Beach, Florida, United States
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1218.43.10018 Boehringer Ingelheim Investigational Site, Decatur, Georgia, United States

and more 50 locations

Safety and Efficacy of Linagliptin (BI 1356) Plus Metformin in Type 2 Diabetes, Factorial Design

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Bi 1356 + metformin
Drug: matching placebo
Drug: metformin
Drug: BI 1356

First Posted Date: 2008-11-25

Last Posted Date: 2014-01-28

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 857

Registration Number: NCT00798161

Locations: 🇨🇦
1218.46.11003 Boehringer Ingelheim Investigational Site, Edmonton, Alberta, Canada
🇨🇦
1218.46.11002 Boehringer Ingelheim Investigational Site, Red Deer, Alberta, Canada
🇨🇦
1218.46.11006 Boehringer Ingelheim Investigational Site, Vancouver, British Columbia, Canada

and more 135 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

The Effect of Linagliptin (BI 1356) on 24h-glucose Control and Various Biomarkers in Type 2 Diabetic Patients

Phase 2

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Placebo (linagliptin)
Drug: Placebo (sitagliptin)
Drug: Sitagliptin
Drug: Linagliptin

First Posted Date: 2008-07-16

Last Posted Date: 2014-06-27

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 121

Registration Number: NCT00716092

Locations: 🇩🇪
1218.37.49003 Boehringer Ingelheim Investigational Site, Berlin, Germany
🇩🇪
1218.37.49002 Boehringer Ingelheim Investigational Site, Mainz, Germany
🇩🇪
1218.37.49001 Boehringer Ingelheim Investigational Site, Neuss, Germany

Japanese P III vs Voglibose and Placebo

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: voglibose
Drug: BI 1356
Drug: voglibose placebo
Drug: BI 1356 placebo

First Posted Date: 2008-04-08

Last Posted Date: 2014-01-27

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 561

Registration Number: NCT00654381

Locations: 🇯🇵
1218.23.33 Boehringer Ingelheim Investigational Site, Osaka, Osaka, Japan
🇯🇵
1218.23.35 Boehringer Ingelheim Investigational Site, Osaka, Osaka, Japan
🇯🇵
1218.23.19 Boehringer Ingelheim Investigational Site, Sapporo, Hokkaido, Japan

and more 44 locations

Efficacy vs Placebo as Initial Combination Therapy With Pioglitazone

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Linagliptin + pioglitazone (30 mg)
Drug: placebo + pioglitazone (30 mg)

First Posted Date: 2008-03-21

Last Posted Date: 2014-02-17

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 389

Registration Number: NCT00641043

Locations: 🇭🇺
1218.15.36002 Boehringer Ingelheim Investigational Site, Szombathely, Hungary
🇪🇸
1218.15.34006 Boehringer Ingelheim Investigational Site, Madrid, Spain
🇬🇷
1218.15.30006 Boehringer Ingelheim Investigational Site, Thessaloniki, Greece

and more 40 locations

Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg
Drug: Placebo identical to BI 1356 5mg
Drug: BI 1356
Drug: Glimepiride

First Posted Date: 2008-02-25

Last Posted Date: 2014-01-29

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 1560

Registration Number: NCT00622284

Locations: 🇺🇸
1218.20.10030 Boehringer Ingelheim Investigational Site, Topeka, Kansas, United States
🇺🇸
1218.20.10035 Boehringer Ingelheim Investigational Site, Los Angeles, California, United States
🇺🇸
1218.20.10003 Boehringer Ingelheim Investigational Site, Chula Vista, California, United States

and more 218 locations

Efficacy and Safety of BI 1356 (Linagliptin) Versus Placebo in Type 2 Diabetic Patients With Insufficient Glycemic Control

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: placebo
Drug: linagliptin

First Posted Date: 2008-02-22

Last Posted Date: 2014-02-17

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 503

Registration Number: NCT00621140

Locations: 🇮🇹
1218.16.39004 Boehringer Ingelheim Investigational Site, Catanzaro, Italy
🇮🇹
1218.16.39008 Boehringer Ingelheim Investigational Site, Genova, Italy
🇮🇹
1218.16.39001 Boehringer Ingelheim Investigational Site, Pisa, Italy

and more 66 locations

Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: linagliptin

First Posted Date: 2008-01-28

Last Posted Date: 2014-01-28

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 701

Registration Number: NCT00601250

Locations: 🇮🇳
1218.17.91002 Boehringer Ingelheim Investigational Site, Bangalore, India
🇮🇳
1218.17.91005 Boehringer Ingelheim Investigational Site, Bangalore, India
🇮🇳
1218.17.91012 Boehringer Ingelheim Investigational Site, Chennai, India

and more 79 locations

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