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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

This Study Tests Whether Taking the Medicines Empagliflozin, Linagliptin, and Metformin Together in 1 Pill is the Same as Taking Them in Separate Pills. The Study is Done in Healthy Men and Women and Measures the Amount of Each Medicine in the Blood

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Empagliflozin/linagliptin/metformin HCl
First Posted Date
2017-08-23
Last Posted Date
2020-03-05
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
30
Registration Number
NCT03259490
Locations
🇩🇪

Humanpharmakologisches Zentrum Biberach, Biberach, Germany

Safety and Efficiency of Linagliptin (Trajenta) in the Setting of Internal Medicine Department

Phase 3
Conditions
DM2
Interventions
Drug: Basal Insulin and Bolus Insulin
First Posted Date
2017-02-13
Last Posted Date
2017-09-11
Lead Sponsor
Rabin Medical Center
Target Recruit Count
60
Registration Number
NCT03051243

Teneligliptin Versus Linagliptin in Diabetes Mellitus Type Two Patients

Phase 4
Completed
Conditions
Type2 Diabetes Mellitus
Interventions
First Posted Date
2017-01-05
Last Posted Date
2019-02-22
Lead Sponsor
Handok Inc.
Target Recruit Count
168
Registration Number
NCT03011177
Locations
🇰🇷

Asan Medical Center, Seoul, Korea, Republic of

Phase IV Clinical Trial to Investigate the Effect on Blood Glucose of Evogliptin in Patients With Type 2 Diabetes(EVERGREEN)

Phase 4
Completed
Conditions
Type2 Diabetes
Interventions
First Posted Date
2016-11-28
Last Posted Date
2018-07-23
Lead Sponsor
Dong-A ST Co., Ltd.
Target Recruit Count
207
Registration Number
NCT02974504
Locations
🇰🇷

Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea, Republic of

Linagliptin Add-on to Insulin Background Therapy

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: placebo
Drug: background therapy
First Posted Date
2016-09-13
Last Posted Date
2020-03-25
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
206
Registration Number
NCT02897349
Locations
🇨🇳

Tianjin Medical University General Hospital, Tianjin, China

🇨🇳

The General Hospital of Chinese People's Armed Police Forces, Beijing, China

🇨🇳

Shengjing Hospital of China Medical University, Shengyang, China

and more 22 locations

Bioequivalence Study of Linagliptin From Prevaglip 5 mg Tablets(Eva Pharma, Egypt) and Trajenta 5 mg Tablets (Boehringer Ingelheim International GmbH, Germany)

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Prevaglip (linagliptin)
First Posted Date
2016-08-05
Last Posted Date
2016-08-05
Lead Sponsor
Genuine Research Center, Egypt
Target Recruit Count
24
Registration Number
NCT02857946
Locations
🇪🇬

Genuine Research Center GRC, Cairo, Egypt

Effects of Linagliptin on Left Ventricular Myocardial DYsfunction in Patients With Type 2 DiAbetes Mellitus and Concentric Left Ventricular Geometry

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Left Ventricular Systolic Dysfunction
Interventions
Drug: Placebo
First Posted Date
2016-08-02
Last Posted Date
2021-05-25
Lead Sponsor
Heart Care Foundation
Target Recruit Count
188
Registration Number
NCT02851745
Locations
🇮🇹

Ospedale Sandro Pertini, Roma, RM, Italy

🇮🇹

Ospedale Casa Sollievo Della Sofferenza, San Giovanni Rotondo, FG, Italy

🇮🇹

Iclas-Istituto Clinico Ligure Alta Spec., Rapallo, GE, Italy

and more 16 locations

The Role of Glucagon in the Effects of Dipeptidyl Peptidase-4 Inhibitors and Sodium-glucose Co-transporter-2 Inhibitors

Not Applicable
Completed
Conditions
Type 2 Diabetes
Interventions
Drug: LY2403021 placebo
Drug: LY2403021
Procedure: Standardised liquid meal
First Posted Date
2016-06-07
Last Posted Date
2020-04-08
Lead Sponsor
University Hospital, Gentofte, Copenhagen
Target Recruit Count
24
Registration Number
NCT02792400
Locations
🇩🇰

Center for Diabetes Research, Gentofte Hospital, Copenhagen University, Hellerup, Denmark

The Effect of Sodium-Glucose Cotransporter 2 Inhibitors on Advanced Glycation End Products

Phase 4
Withdrawn
Conditions
SGLT-2 Inhibitors
Advanced Glycation End Products
Diabetes
Interventions
First Posted Date
2016-05-11
Last Posted Date
2018-02-15
Lead Sponsor
Northwell Health
Registration Number
NCT02768220

Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Linagliptin Compared With the Free Combination of Empagliflozin Tablet and Linagliptin Tablet in Healthy Male and Female Subjects

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2016-05-02
Last Posted Date
2017-11-22
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
56
Registration Number
NCT02758171
Locations
🇩🇪

Humanpharmakologisches Zentrum Biberach, Biberach, Germany

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