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
Diastolic Dysfunction in Patients With Type 2 Diabetes Mellitus
- Conditions
- Diabetes Mellitus Type 2 (T2DM)Left Ventricular Diastolic Dysfunction
- Interventions
- Drug: placebo
- First Posted Date
- 2013-06-28
- Last Posted Date
- 2017-04-12
- Lead Sponsor
- RWTH Aachen University
- Target Recruit Count
- 8
- Registration Number
- NCT01888796
- Locations
- 🇩🇪
Department of Internal Medicine I, University Hospital, Aachen, Germany
Relative Bioavailability of 2 Fixed Dose Combinations of Linagliptin/Metformin Compared With Single Tablets
- Conditions
- Healthy
- Interventions
- Drug: 2x500 mg Metformin (Glumetza)Drug: 2 x 2.5 mg Linagliptin/750 mg Metformin FDCDrug: 5 mg Linagliptin/1000 mg Metformin FDCDrug: 3x500 mg Metformin (Glumetza)Drug: 5 mg Linagliptin/1000mg Metformin FDCDrug: 2 x 500 mg Metformin (Glumetza)
- First Posted Date
- 2013-05-03
- Last Posted Date
- 2014-08-19
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 72
- Registration Number
- NCT01845077
- Locations
- 🇺🇸
1288.8.1 Boehringer Ingelheim Investigational Site, Austin, Texas, United States
Effects of Linagliptin on Renal Endothelium Function in Patients With Type 2 Diabetes.
- First Posted Date
- 2013-04-19
- Last Posted Date
- 2018-01-12
- Lead Sponsor
- University of Erlangen-Nürnberg Medical School
- Target Recruit Count
- 65
- Registration Number
- NCT01835678
- Locations
- 🇩🇪
Clinical Research Unit, Department of Nephrology and Hypertension, University of Erlangen-Nürnberg, Nuremberg, Germany
Linagliptin Among Filipino Patients With Type 2 Diabetes Mellitus
- First Posted Date
- 2013-04-08
- Last Posted Date
- 2014-09-18
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 678
- Registration Number
- NCT01826370
- Locations
- 🇵🇭
Boehringer Ingelheim Investigational Site 42, Cardona, Rizal, Philippines
🇵🇭Boehringer Ingelheim Investigational Site 24, Las Pinas, Philippines
🇵🇭Boehringer Ingelheim Investigational Site 25, Cebu, Philippines
MARLINA - T2D : Efficacy, Safety & Modification of Albuminuria in Type 2 Diabetes Subjects With Renal Disease With LINAgliptin
- First Posted Date
- 2013-02-15
- Last Posted Date
- 2017-03-06
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 360
- Registration Number
- NCT01792518
- Locations
- 🇻🇳
Boehringer Ingelheim Investigational Site, Ho Chi Minh City, Vietnam
Safety and Efficacy of the Combination of Empagliflozin and Linagliptin Compared to Linagliptin Alone Over 24 Weeks in Patients With Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- First Posted Date
- 2012-11-28
- Last Posted Date
- 2016-07-11
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 607
- Registration Number
- NCT01734785
- Locations
- 🇪🇸
1275.9.34011 Boehringer Ingelheim Investigational Site, A Coruña, Spain
🇪🇸1275.9.34009 Boehringer Ingelheim Investigational Site, Alicante, Spain
🇳🇴1275.9.47006 Boehringer Ingelheim Investigational Site, Svelvik, Norway
Study to Compare the Efficacy and Safety of Administration of the Fix Dose Combination of Linagliptin Plus Metformin in Drug naïve Type 2 Patients
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: linagliptin2.5mg/metformin500mgDrug: linagliptin2.5mg/metformin1000mg
- First Posted Date
- 2012-10-17
- Last Posted Date
- 2015-04-24
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 876
- Registration Number
- NCT01708902
- Locations
- 🇨🇳
1288.18.86010 Boehringer Ingelheim Investigational Site, Guangzhou, China
🇨🇳1288.18.86039 Boehringer Ingelheim Investigational Site, Nanchang, China
🇨🇳1288.18.86024 Boehringer Ingelheim Investigational Site, Xi'An, China
A Non Interventional Study to Monitor the Safety and Effectiveness of Trajenta (Linagliptin, 5 mg, q.d) in Korean Patients With Type 2 Diabetes Mellitus
- First Posted Date
- 2012-10-16
- Last Posted Date
- 2019-01-11
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 3219
- Registration Number
- NCT01707147
Trial to Assess the Influence of 4 Weeks' Treatment With Linagliptin as Compared to Glimepiride and Placebo on Endothelial Function in Patients With Type 2 Diabetes Using FMD (Flow-Mediated Vasodilation)
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- First Posted Date
- 2012-10-10
- Last Posted Date
- 2015-01-19
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 42
- Registration Number
- NCT01703286
- Locations
- 🇩🇪
1218.105.001 Boehringer Ingelheim Investigational Site, Neuss, Germany
Rapid Effects Linagliptin on Monocyte Polarization and Endothelial Progenitor Cells in Type 2 Diabetes
- Conditions
- Type 2 DiabetesChronic Renal Failure
- Interventions
- Drug: Placebo
- First Posted Date
- 2012-06-12
- Last Posted Date
- 2014-12-19
- Lead Sponsor
- University of Padova
- Target Recruit Count
- 45
- Registration Number
- NCT01617824
- Locations
- 🇮🇹
University Hospital Diabetes Outpatient Clinic, Padova, Italy
Drug Development Updates
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