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Linagliptin

Generic Name
Linagliptin
Brand Names
Glyxambi, Jentadueto, Tradjenta, Trajenta, Trijardy
Drug Type
Small Molecule
Chemical Formula
C25H28N8O2
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
Related News

Bioequivalence of Metformin Under Fed Conditions After Administration of Linagliptin / Metformin Fixed Dose Combination Tablet and Single Tablets

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Linagliptin/metformin
First Posted Date
2012-04-20
Last Posted Date
2013-08-20
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
32
Registration Number
NCT01581931
Locations
🇩🇪

1288.20.1 Boehringer Ingelheim Investigational Site, Biberach, Germany

Effect of Linagliptin in Comparison With Glimepiride as Add on to Metformin on Postprandial Beta Cell Function, Postprandial Metabolism and Oxidative Stress in Patients With Type 2 Diabetes Mellitus

Phase 4
Conditions
Diabetes Mellitus Type 2
Interventions
First Posted Date
2012-03-07
Last Posted Date
2012-04-11
Lead Sponsor
Marcus Borchert
Target Recruit Count
40
Registration Number
NCT01547104
Locations
🇩🇪

ikfe GmbH, Mainz, Rhineland-Palatinate, Germany

Linagliptin and Metformin Versus Linagliptin in Newly Diagnosed, Untreated Type 2 Diabetes

Phase 4
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2012-01-20
Last Posted Date
2014-05-20
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
316
Registration Number
NCT01512979
Locations
🇺🇸

1218.83.11022 Boehringer Ingelheim Investigational Site, Fort Lauderdale, Florida, United States

🇺🇸

1218.83.11013 Boehringer Ingelheim Investigational Site, Jacksonville, North Carolina, United States

🇺🇸

1218.83.11017 Boehringer Ingelheim Investigational Site, Chattanooga, Tennessee, United States

and more 79 locations

Linagliptin in Combination With Metformin in Treatment Naive Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control

Phase 4
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2011-09-22
Last Posted Date
2014-11-25
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
689
Registration Number
NCT01438814
Locations
🇧🇪

1218.60.32001 Boehringer Ingelheim Investigational Site, Genk, Belgium

🇧🇪

1218.60.32005 Boehringer Ingelheim Investigational Site, Ham, Belgium

🇧🇪

1218.60.32004 Boehringer Ingelheim Investigational Site, Natoye, Belgium

and more 87 locations

Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: high dose FDC
Drug: low dose FDC placebo
Drug: BI 10773 high dose
Drug: high dose FDC placebo
Drug: low dose FDC
Drug: high dose BI 10773 placebo
Drug: low dose BI 10773 placebo
Drug: BI 10773 low dose placebo
Drug: BI 10773 low dose
First Posted Date
2011-08-25
Last Posted Date
2015-04-02
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
1405
Registration Number
NCT01422876
Locations
🇺🇸

1275.1.01043 Boehringer Ingelheim Investigational Site, Mobile, Alabama, United States

🇺🇸

1275.1.01039 Boehringer Ingelheim Investigational Site, Atlanta, Georgia, United States

🇺🇸

1275.1.01003 Boehringer Ingelheim Investigational Site, Shreveport, Louisiana, United States

and more 208 locations

Comparison of the Bioavailability of Metformin Between Medium Dose Linagliptin/Metformin Tablets and Medium Dose Glucophage Tablet Given With Linagliptin Tablet

Phase 1
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: Linagliptin/Metformin Combo
First Posted Date
2011-06-28
Last Posted Date
2014-03-28
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
58
Registration Number
NCT01383356
Locations
🇨🇦

1288.19.1 Boehringer Ingelheim Investigational Site, Toronto, Ontario, Canada

Bioequivalence of a Fixed Dose Combination Tablet Linagliptin/Pioglitazone Compared With Its Mono-components

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Linagliptin/Pioglitazone
First Posted Date
2011-01-13
Last Posted Date
2014-06-09
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
64
Registration Number
NCT01276327
Locations
🇩🇪

1264.14.1 Boehringer Ingelheim Investigational Site, Biberach, Germany

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

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
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
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
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
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