MedPath

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

HSK7653 Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: HSK7653 10 mg Q2W
Drug: HSK7653 25 mg Q2W
First Posted Date
2020-09-25
Last Posted Date
2022-12-12
Lead Sponsor
Sichuan Haisco Pharmaceutical Group Co., Ltd
Target Recruit Count
465
Registration Number
NCT04564872
Locations
🇨🇳

Inner Mongolia Baogang Hospital, Baotou, Inner Mongolia, China

🇨🇳

Peking University People's Hospital, Beijing, Beijing, China

Dipeptidyl Peptidase-4 Inhibitor (DPP4i) for the Control of Hyperglycemia in Patients With COVID-19

Phase 3
Completed
Conditions
Hyperglycemia
Covid19
Interventions
First Posted Date
2020-09-09
Last Posted Date
2021-03-23
Lead Sponsor
Hospital Regional de Alta Especialidad del Bajio
Target Recruit Count
70
Registration Number
NCT04542213
Locations
🇲🇽

Hospital Regional de Alta Especialidad del Bajìo, Leòn, Guanajuato, Mexico

Efficacy and Safety of Dipeptidyl Peptidase-4 Inhibitors in Diabetic Patients With Established COVID-19

Phase 3
Terminated
Conditions
Metabolic Disease
Endocrine System Diseases
COVID 19
Coronavirus
Diabetes Mellitus, Type 2
Diabetes Mellitus
Dipeptidyl-Peptidase IV Inhibitors
Linagliptin
Severe Acute Respiratory Syndrome Coronavirus 2
Sars-CoV2
Interventions
First Posted Date
2020-05-01
Last Posted Date
2021-06-02
Lead Sponsor
Rabin Medical Center
Target Recruit Count
64
Registration Number
NCT04371978
Locations
🇮🇱

Shamir Medical Center, Be'er Ya'aqov, Israel

🇮🇱

Rabin Medical Center, Hasharon Campus, Petah tikva, Israel

🇮🇱

Rabin Medical Center, Beilinson Campus, Petah tikva, Israel

Effects of DPP4 Inhibition on COVID-19

Phase 4
Withdrawn
Conditions
Coronavirus Infection
Type 2 Diabetes
Interventions
Drug: Insulin regimen
First Posted Date
2020-04-10
Last Posted Date
2021-06-10
Lead Sponsor
University of Miami
Registration Number
NCT04341935
Locations
🇺🇸

University of Miami, Miami, Florida, United States

Real-world Study Comparing the Adherence and Effectiveness of Linagliptin vs. Acarbose

Terminated
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2019-11-29
Last Posted Date
2022-06-23
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
85
Registration Number
NCT04180813
Locations
🇨🇳

Huai'an first people's hospital, Huai'an, China

🇨🇳

Dongying People's Hospital, Dongying, China

🇨🇳

Zhongda Hospital Southeast University, Nanjing, China

and more 7 locations

Effect of Linagliptin + Metformin on Patients Who do Not Achieve Normoglucemia With Metformine

Phase 4
Completed
Conditions
Impaired Glucose Tolerance
Prediabetic State
Insulin Resistance
Interventions
First Posted Date
2019-09-12
Last Posted Date
2019-09-13
Lead Sponsor
Universidad de Guanajuato
Target Recruit Count
31
Registration Number
NCT04088461
Locations
🇲🇽

Universidad de Guanajuato, León, Guanajuato, Mexico

Study of TQ-F3083 Capsules in Subjects With Type 2 Diabetes Mellitus

Phase 2
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: TQ-F3083 capsule 10 mg
Drug: TQ-F3083 capsule 20 mg
Drug: TQ-F3083 blank analog capsule
First Posted Date
2019-06-14
Last Posted Date
2020-03-13
Lead Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Target Recruit Count
120
Registration Number
NCT03986073
Locations
🇨🇳

The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China

🇨🇳

The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China

🇨🇳

Xiangya Hospital Central South University, Changsha, Hunan, China

and more 6 locations

Linagliptin in Post-renal Transplantation

Completed
Conditions
Transplanted Kidney Complication
Interventions
First Posted Date
2019-05-31
Last Posted Date
2019-06-04
Lead Sponsor
Universidad de Guanajuato
Target Recruit Count
28
Registration Number
NCT03970668

Replication of the CARMELINA Diabetes Trial in Healthcare Claims

Completed
Conditions
Diabetes
Interventions
Drug: Sulfonylurea
First Posted Date
2019-05-03
Last Posted Date
2023-07-27
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
101830
Registration Number
NCT03936036
Locations
🇺🇸

Brigham & Women's Hospital, Boston, Massachusetts, United States

Efficacy and Safety of Lima Association in the Control of Type II Diabetes Mellitus.

Phase 3
Withdrawn
Conditions
Type2 Diabetes Mellitus
Interventions
Drug: LIMA association
First Posted Date
2018-12-06
Last Posted Date
2022-07-27
Lead Sponsor
EMS
Registration Number
NCT03766750
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