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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

Pharmacokinetics, Safety and Tolerability of Digoxin With or Without Co-administration of BI 1356 in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2014-07-08
Last Posted Date
2014-07-08
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
20
Registration Number
NCT02183402

Pharmacokinetics of Single and Multiple Oral Doses of BI 1356 in Healthy Chinese Volunteers

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2014-07-08
Last Posted Date
2014-07-08
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
12
Registration Number
NCT02183532

Bioavailability of BI 1356 Administered With and Without Food to Healthy Male and Female Subjects

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2014-07-08
Last Posted Date
2014-07-08
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
32
Registration Number
NCT02183493

Bioavailability of BI 1356 and Glyburide in Healthy Male and Female Volunteers

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: BI 1356 + Glyburide
First Posted Date
2014-07-08
Last Posted Date
2014-07-08
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
20
Registration Number
NCT02183428

Bioavailability of BI 1356 After Co-administration With Ritonavir Compared to the Bioavailability of BI 1356 Alone in Healthy Male Volunteers

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2014-07-08
Last Posted Date
2014-07-08
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
12
Registration Number
NCT02183441

Bioavailability of Warfarin After Coadministration With Multiple Doses of BI 1356 Compared to the Bioavailability of Warfarin Alone in Healthy Male Volunteers

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2014-07-08
Last Posted Date
2014-07-08
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
18
Registration Number
NCT02183389

Pharmacokinetics and Pharmacodynamics of BI 1356 in Subjects With Different Degrees of Liver Impairment as Compared to Healthy Subjects

Phase 1
Completed
Conditions
Hepatic Insufficiency
Interventions
First Posted Date
2014-07-08
Last Posted Date
2014-07-08
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
33
Registration Number
NCT02183376

Relative Bioavailability of Two Fixed Dose Combination Tablets of Linagliptin/Pioglitazone Compared With Single Linagliptin and Pioglitazone Tablets Administered Together to Healthy Male and Female Subjects

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Linagliptin/pioglitazone, FDC formulation C8
Drug: Linagliptin/pioglitazone, FDC formulation C5
First Posted Date
2014-07-08
Last Posted Date
2014-07-08
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
39
Registration Number
NCT02183636

The Effect of Combination of Mosapride and DPP-4 Inhibitor on Plasma Concentration of Incretin Hormones

Phase 4
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2014-07-02
Last Posted Date
2017-11-29
Lead Sponsor
Seoul National University Hospital
Target Recruit Count
12
Registration Number
NCT02180334
Locations
🇰🇷

Seoul National University Hospital, Seoul, Korea, Republic of

Effect of Multiple BI 1356 Doses of on the Multiple-dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Healthy Female Premenopausal Subjects

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Microgynon®
First Posted Date
2014-06-26
Last Posted Date
2014-07-08
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
18
Registration Number
NCT02175394
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