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
Effect of Linagliptin on TRL Metabolism
- First Posted Date
- 2014-10-31
- Last Posted Date
- 2014-11-04
- Lead Sponsor
- Ministry of Public Health, Argentina
- Target Recruit Count
- 20
- Registration Number
- NCT02280174
- Locations
- 🇦🇷
National University of Formosa, Formosa, Argentina
Linagliptin as Add on to Basal Insulin in the Elderly
- First Posted Date
- 2014-09-16
- Last Posted Date
- 2018-07-03
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 302
- Registration Number
- NCT02240680
- Locations
- 🇯🇵
Jiyugaoka Yamada Clinic, Hokkaido, Obihiro, Japan
🇯🇵Yoshida Memorial Hospital, Hokkaido, Sapporo, Japan
🇺🇸East Coast Institute for Research LLC at NE FL Endo & Diabetes, Jacksonville, Florida, United States
Bioequivalence of a 2.5 mg Linagliptin / 850 mg Metformin Fixed Dose Combination Tablet Compared With Single Linagliptin 2.5 mg and Metformin 850 mg Tablets in Healthy Volunteers
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2014-08-20
- Last Posted Date
- 2014-08-20
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 96
- Registration Number
- NCT02220647
Bioequivalence of a 2.5 mg Linagliptin / 500 mg Metformin Fixed Dose Combination Tablet Compared With Single Linagliptin 2.5 mg and Metformin 500 mg Tablets Administered Together in Healthy Volunteers
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2014-08-20
- Last Posted Date
- 2014-08-20
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 95
- Registration Number
- NCT02221414
Bioequivalence of a Linagliptin / Metformin Fixed-dose Combination (FDC) Tablet Compared With Single Linagliptin and Metformin Tablets Administered Together in Healthy Volunteers
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2014-08-20
- Last Posted Date
- 2014-08-20
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 96
- Registration Number
- NCT02221401
the Pharmacokinetic Profiles of Linagliptin With DW1029M
- Conditions
- Healthy
- Interventions
- Drug: DW1029M 1200mg and Linagliptin 5mg
- First Posted Date
- 2014-08-08
- Last Posted Date
- 2015-06-29
- Lead Sponsor
- Dong Wha Pharmaceutical Co. Ltd.
- Target Recruit Count
- 12
- Registration Number
- NCT02212782
- Locations
- 🇰🇷
Chonbuk National University Hospital, Jeonju, Jeollabukdo, Korea, Republic of
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Single and Multiple Doses of Linagliptin Tablets in Patients With Different Degrees of Renal Impairment in Comparison to Subjects With Normal Renal Function
- Conditions
- Renal Insufficiency
- Interventions
- First Posted Date
- 2014-07-16
- Last Posted Date
- 2014-07-16
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 51
- Registration Number
- NCT02191228
Bioavailability of BI 1356 BS and Metformin After Co-administration Compared to the Bioavailability of BI 1356 BS Alone and Metformin Alone in Healthy Male Volunteers
- First Posted Date
- 2014-07-08
- Last Posted Date
- 2014-07-08
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 16
- Registration Number
- NCT02183506
Study to Evaluate the Effect of Multiple Doses of Rifampicin on the Multiple-dose Pharmacokinetics of Linagliptin in Healthy Volunteers
- First Posted Date
- 2014-07-08
- Last Posted Date
- 2014-07-08
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 16
- Registration Number
- NCT02183584
Bioavailability of BI 1356 With and Without Co-administration of Pioglitazone and the Bioavailability of Pioglitazone With and Without Coadministration of BI 1356 in Healthy Male and Female Volunteers
- 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
- NCT02183337
Drug Development Updates
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