Clinical Trials

Linagliptin has been evaluated in numerous clinical trials spanning Phase 1 through Phase 4, primarily targeting metabolic disorders such as type 2 diabetes mellitus, prediabetic states, impaired glucose tolerance, and insulin resistance, alongside secondary conditions including hypertension, osteoporosis, and coronavirus infection. Sponsored by pharmaceutical entities like Boehringer Ingelheim and academic medical centers such as Brigham and Women's Hospital and Mackay Memorial Hospital, these completed, recruiting, and terminated studies have assessed both monotherapy and combination regimens.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07786571 NOT_YET_RECRUITING
Type 2 Diabetes Mellitus (T2DM); Chronic Renal Insufficiency; Chronic Kidney Disease (Stages 3b-5); Glucose Homeostasis
Sun Yat-sen University
 2026-12-01
NCT07442006 RECRUITING
Type 2 Diabetes Mellitus (T2DM)
JW Pharmaceutical
 2025-10-29 PHASE4
NCT06449833 RECRUITING
Type2 Diabetes Mellitus; Nonalcoholic Fatty Liver Disease
Zhujiang Hospital
 2024-06 PHASE4
NCT07019012 RECRUITING
T2DM
Huazhong University of Science and Technology
 2025-07-30 PHASE4
NCT04670666 RECRUITING
Type 2 Diabetes Mellitus
EMS
 2024-11-18 PHASE3
NCT06851962 COMPLETED
Diabetes Mellitus Type 2
Fundación para la Investigación del Hospital Clínico de Valencia
 2025-05-26 PHASE4
NCT07691203 COMPLETED
Type 2 Diabetes Mellitus (T2DM); Cardiovascular Diseases
Humanis Saglık Anonim Sirketi
 2026-03-07 PHASE1
NCT05886088 NOT_YET_RECRUITING
Type 2 Diabetes Mellitus
EMS
 2024-02 PHASE3
NCT06862739 RECRUITING
Diabetes Mellitus; Type 2 DM
Nabiqasim Industries (Pvt) Ltd
 2025-10-30 PHASE4
NCT07452913 ENROLLING_BY_INVITATION
Type 2 Diabetes Mellitus
Bahria University
 2026-01-01 PHASE4
NCT05313529 COMPLETED
Type 2 Diabetes Mellitus; Mild Cognitive Impairment
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
 2022-10-08
NCT07044765 NOT_YET_RECRUITING
Type2 Diabetes Mellitus
AJU Pharm Co., Ltd.
 2025-08 PHASE1
NCT07034781 NOT_YET_RECRUITING
Type2 Diabetes Mellitus
AJU Pharm Co., Ltd.
 2025-08 PHASE1
NCT03337698 TERMINATED
Carcinoma, Non-Small-Cell Lung
Hoffmann-La Roche
 2017-12-27 PHASE1; PHASE2
NCT03281369 TERMINATED
Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma
Hoffmann-La Roche
 2017-10-13 PHASE1; PHASE2
NCT06095492 RECRUITING
Kidney Transplant; Complications; Diabetes Mellitus
Medanta, The Medicity, India
 2023-10-30
NCT07213895 COMPLETED
Type 2 Diabetes Mellitus (T2DM)
Humanis Saglık Anonim Sirketi
 2025-05-21 PHASE1
NCT06098625 UNKNOWN
Diabetes Mellitus; Kidney Transplant; Complications
Medanta, The Medicity, India
 2023-11-10
NCT07039890 COMPLETED
Type 2 Diabetes Mellitus (T2DM)
Humanis Saglık Anonim Sirketi
 2025-03-08 PHASE1
NCT06932159 COMPLETED
Type 2 Diabetes Mellitus (T2DM)
Humanis Saglık Anonim Sirketi
 2024-12-23 PHASE1
NCT06243809 UNKNOWN
Healthy Volunteer
International Bio service
 2024-04-24 PHASE1
NCT07247656 COMPLETED
Diabete Mellitus
Bahria University
 2022-12-01 PHASE4
NCT03194945 COMPLETED
Type 2 Diabetes Mellitus
Sun Yat-sen University
 2017-11-01 PHASE4
NCT04662866 UNKNOWN
Impaired Glucose Tolerance; Insulin Sensitivity; Glucose Metabolism Disorders
Oslo University Hospital
 2021-02-10 PHASE2
NCT05956522 COMPLETED
Healthy
The Affiliated Hospital of Qingdao University
 2022-07-01 PHASE1
NCT03429543 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2018-03-20 PHASE3
NCT05200793 UNKNOWN
Polycystic Ovary Syndrome (PCOS)
Alexandria University
 2021-12-07 PHASE4
NCT04564872 COMPLETED
Diabetes Mellitus, Type 2
Sichuan Haisco Pharmaceutical Group Co., Ltd
 2020-11-13 PHASE3
NCT04341935 WITHDRAWN
Coronavirus Infection; Type 2 Diabetes
University of Miami
 2021-06-30 PHASE4
NCT03433248 UNKNOWN
Type2 Diabetes
M.H.H. Kramer
 2017-11-09 PHASE4
NCT04371978 TERMINATED
COVID 19; Coronavirus; Diabetes Mellitus, Type 2; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Disease; Endocrine System Diseases; Dipeptidyl-Peptidase IV Inhibitors; Linagliptin; Severe Acute Respiratory Syndrome Coronavirus 2; Sars-CoV2; Hypoglycemic Agents; Respiratory Tract Diseases; Incretins; Hormones
Rabin Medical Center
 2020-10-01 PHASE3
NCT05290506 COMPLETED
PreDiabetes; Type 2 Diabetes
National University of Malaysia
 2020-08-01 PHASE3
NCT04542213 COMPLETED
Hyperglycemia; Covid19
Hospital Regional de Alta Especialidad del Bajio
 2020-08-01 PHASE3
NCT04131582 UNKNOWN
Prediabetic State; Insulin Resistance
Universidad de Guanajuato
 2019-09-01 PHASE3
NCT05066516 COMPLETED
Diabetes Mellitus
Korea University Anam Hospital
 2020-06-25 PHASE1
NCT04134650 UNKNOWN
Prediabetic State; Insulin Resistance
Universidad de Guanajuato
 2019-09-01 PHASE3
NCT03986073 UNKNOWN
Type 2 Diabetes Mellitus
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
 2020-01-01 PHASE2
NCT01750918 COMPLETED
Cancer
Novartis Pharmaceuticals
 2012-12-19 PHASE1; PHASE2
NCT04180813 Terminated
Diabetes Mellitus Type 2
Boehringer Ingelheim
 2020-03-04 --
NCT03320031 UNKNOWN
Type 2 Diabetes Mellitus; Peritoneal Dialysis
Yanbing Li
 2017-06-03 PHASE4
NCT02851745 COMPLETED
Diabetes Mellitus, Type 2; Left Ventricular Systolic Dysfunction
Heart Care Foundation
 2015-07 PHASE3
NCT03504566 WITHDRAWN
Diabetic Nephropathy Type 2
Steno Diabetes Center Copenhagen
 2017-11-15 PHASE4
NCT03667300 COMPLETED
Type2 Diabetes Mellitus; Albuminuria; Renal Insufficiency
Samsung Medical Center
 2017-03-16 PHASE2
NCT03004612 COMPLETED
Prediabetic State; Insulin Resistance
Universidad de Guanajuato
 2016-01 PHASE4
NCT01682213 COMPLETED
Melanoma
Memorial Sloan Kettering Cancer Center
 2012-09 PHASE2
NCT02467478 COMPLETED
Type 2 Diabetes; Impaired Renal Function
George Washington University
 2015-04 PHASE4
NCT03609294 COMPLETED
Hypertension; Diabetes
Boryung Pharmaceutical Co., Ltd
 2018-07-18 PHASE1
NCT03642184 TERMINATED
New Onset Diabetes After Transplant; Kidney Transplant; Complications
RenJi Hospital
 2018-07-14 PHASE4
NCT02897349 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2016-09-30 PHASE3
NCT03222765 UNKNOWN
PreDiabetes
Evidem Consultores SL
 2015-03-15
NCT02752113 COMPLETED
Diabetes Mellitus Type 2
Institut für Pharmakologie und Präventive Medizin
 2016-04 PHASE3
NCT03629054 COMPLETED
Healthy
Boehringer Ingelheim
 2018-08-27 PHASE1
NCT03051243 UNKNOWN
DM2
Rabin Medical Center
 2017-10-01 PHASE3
NCT03458715 UNKNOWN
Type2 Diabetes
Mackay Memorial Hospital
 2017-09-21 PHASE4
NCT04088461 COMPLETED
Prediabetic State; Impaired Glucose Tolerance; Insulin Resistance
Universidad de Guanajuato
 2016-09 PHASE4
NCT03011177 COMPLETED
Type2 Diabetes Mellitus
Handok Inc.
 2017-01 PHASE4
NCT01243424 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2010-11-11 PHASE3
NCT02768220 WITHDRAWN
SGLT-2 Inhibitors; Advanced Glycation End Products; Diabetes
Northwell Health
 2017-12-01 PHASE4
NCT01943019 TERMINATED
Schizophrenia
Monash University
 2013-08 PHASE1
NCT01231594 COMPLETED
Cancer
Novartis Pharmaceuticals
 2010-11-05 PHASE1
NCT02442817 COMPLETED
Schizophrenia
University of Nevada, Reno
 2015-03-02 PHASE4
NCT02974504 COMPLETED
Type2 Diabetes
Dong-A ST Co., Ltd.
 2016-09 PHASE4
NCT02372630 COMPLETED
Type 2 Diabetes
University at Buffalo
 2014-05-23 PHASE4
NCT01897532 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2013-07-10 PHASE4
NCT03259490 COMPLETED
Healthy
Boehringer Ingelheim
 2017-08-31 PHASE1
NCT03250052 COMPLETED
Hypertension
Boryung Pharmaceutical Co., Ltd
 2017-08-14 PHASE1
NCT02608177 COMPLETED
Chronic Kidney Diseases; Type 2 Diabetes
University of Washington
 2015-11
NCT02429232 UNKNOWN
Osteoporosis; Diabetes Mellitus
National Taiwan University Hospital
 2015-10 PHASE4
NCT01682083 COMPLETED
Melanoma
Novartis Pharmaceuticals
 2013-01-08 PHASE3
NCT02240680 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2014-09-23 PHASE4
NCT02061969 COMPLETED
Diabetes
Emory University
 2014-04-25 PHASE4
NCT02004366 COMPLETED
Type 2 Diabetes
Emory University
 2014-01 PHASE4
NCT02350478 COMPLETED
Type 2 Diabetes; Coronary Artery Disease
Medical University of Graz
 2013-07 PHASE4
NCT02489968 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2015-05-12 PHASE3
NCT02815644 COMPLETED
Healthy
Boehringer Ingelheim
 2016-07-15 PHASE1
NCT02821910 COMPLETED
Healthy
Boehringer Ingelheim
 2016-07-20 PHASE1
NCT02453555 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2015-05-14 PHASE3
NCT02792400 COMPLETED
Type 2 Diabetes
University Hospital, Gentofte, Copenhagen
 2016-05
NCT02758171 COMPLETED
Healthy
Boehringer Ingelheim
 2016-05-17 PHASE1
NCT02082665 COMPLETED
Cancer
GlaxoSmithKline
 2015-02-19 PHASE1
NCT01969084 COMPLETED
Type II Diabetes Mellitus
Beth Israel Deaconess Medical Center
 2013-10 PHASE4
NCT02106104 COMPLETED
Type 2 Diabetes
Amsterdam UMC, location VUmc
 2014-03 PHASE4
NCT02725502 UNKNOWN
Type 1 Diabetes Mellitus
Post Graduate Institute of Medical Education and Research, Chandigarh
 2013-07
NCT01903070 COMPLETED
Diabetes Mellitus
Profil Institut für Stoffwechselforschung GmbH
 2013-07-11 PHASE4
NCT02857946 COMPLETED
Healthy
Genuine Research Center, Egypt
 2016-02 PHASE1
NCT01954043 COMPLETED
Cancer
GlaxoSmithKline
 2013-12-20 PHASE1
NCT01342484 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2011-04 PHASE2
NCT02015299 COMPLETED
Type 2 Diabetes Mellitus
dr. DJ Mulder
 2014-03 PHASE3
NCT01907802 TERMINATED
BRAF Gene Mutation; Hepatic Complication; Renal Failure; Solid Neoplasm
National Cancer Institute (NCI)
 2013-08-23 PHASE1
NCT02401880 COMPLETED
Type 2 Diabetes Mellitus
Profil Institut für Stoffwechselforschung GmbH
 2015-05 PHASE4
NCT01792518 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2013-02 PHASE3
NCT02072096 TERMINATED
Diabetes Mellitus, Type 2
Eli Lilly and Company
 2014-02 PHASE4
NCT02092597 COMPLETED
Type 2 Diabetes Mellitus
Charles University, Czech Republic
 2013-10 PHASE4
NCT01968044 COMPLETED
Type 2 DM Patients With Moderate or Severe Renal Impairment
LG Life Sciences
 2013-10 PHASE3
NCT02077309 TERMINATED
Diabetes Mellitus Type 2 (T2DM); Vascular Inflammation; Plaque Morphology
RWTH Aachen University
 2014-08 PHASE3
NCT01619774 COMPLETED
Melanoma
M.D. Anderson Cancer Center
 2012-09 PHASE2
NCT01734785 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2013-02-08 PHASE3
NCT01778049 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2013-01 PHASE3
NCT01617824 COMPLETED
Type 2 Diabetes; Chronic Renal Failure
University of Padova
 2012-09 PHASE4
NCT01888796 TERMINATED
Diabetes Mellitus Type 2 (T2DM); Left Ventricular Diastolic Dysfunction
RWTH Aachen University
 2013-09 PHASE3
NCT01738451 COMPLETED
Cancer
GlaxoSmithKline
 2013-01-22 PHASE1
NCT02280174 UNKNOWN
Type 2 Diabetes
Ministry of Public Health, Argentina
 2014-09 PHASE4
NCT02097342 UNKNOWN
Type 2 Diabetes Mellitus; Insulin Sensitivity/Resistance
Post Graduate Institute of Medical Education and Research, Chandigarh
 2013-12 PHASE4
NCT02180334 COMPLETED
Diabetes Mellitus, Type 2
Seoul National University Hospital
 2014-07 PHASE4
NCT02212782 COMPLETED
Healthy
Dong Wha Pharmaceutical Co. Ltd.
 2014-09 PHASE1
NCT01928940 COMPLETED
Solid Tumours
GlaxoSmithKline
 2013-08-15 PHASE2
NCT02376075 COMPLETED
Arterial Hypertension; Albuminuria
ikfe-CRO GmbH
 2013-01 PHASE3
NCT01582997 COMPLETED
Cancer
GlaxoSmithKline
 2012-05-11 PHASE1
NCT02084082 COMPLETED
Healthy
Boehringer Ingelheim
 2014-04 PHASE1
NCT02121509 COMPLETED
Healthy
Boehringer Ingelheim
 2014-05 PHASE1
NCT02084056 COMPLETED
Healthy
Boehringer Ingelheim
 2014-04 PHASE1
NCT01708902 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2012-10 PHASE3
NCT01835678 COMPLETED
Type 2-diabetes
University of Erlangen-Nürnberg Medical School
 2012-10 PHASE3
NCT01534897 COMPLETED
Papillary Thyroid Carcinoma
Massachusetts General Hospital
 2012-07
NCT01703286 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2012-10 PHASE1
NCT01947153 COMPLETED
Healthy
Boehringer Ingelheim
 2013-11 PHASE1
NCT01422876 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2011-08 PHASE3
NCT01845077 COMPLETED
Healthy
Boehringer Ingelheim
 2013-05 PHASE1
NCT01512979 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2012-01 PHASE4
NCT01438814 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2011-11 PHASE4
NCT01183013 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2010-08 PHASE3
NCT01340846 COMPLETED
Cancer
GlaxoSmithKline
 2012-09-03 PHASE1
NCT01547104 UNKNOWN
Diabetes Mellitus Type 2
Marcus Borchert
 2012-04 PHASE4
NCT01581931 COMPLETED
Healthy
Boehringer Ingelheim
 2012-04 PHASE1
NCT01540487 COMPLETED
Healthy
Boehringer Ingelheim
 2012-02 PHASE1
NCT01072175 COMPLETED
Cancer
Novartis Pharmaceuticals
 2010-03-26 PHASE2
NCT01214239 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2010-10 PHASE3
NCT01087502 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2010-03 PHASE3
NCT01215097 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2010-10 PHASE3
NCT00996658 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2009-10 PHASE3
NCT01204294 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2010-09 PHASE3
NCT01227889 COMPLETED
Cancer
GlaxoSmithKline
 2010-12-23 PHASE3
NCT01383356 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2011-06 PHASE1
NCT01266967 COMPLETED
Melanoma and Brain Metastases
GlaxoSmithKline
 2011-02 PHASE2
NCT01194830 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2010-09 PHASE3
NCT01340833 COMPLETED
Cancer
GlaxoSmithKline
 2011-06-08 PHASE1
NCT00954447 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2009-08 PHASE3
NCT01153763 COMPLETED
Melanoma
GlaxoSmithKline
 2010-08-09 PHASE2
NCT00915772 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2009-06 PHASE3
NCT01084005 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2010-03 PHASE3
NCT01231568 COMPLETED
Cancer
GlaxoSmithKline
 2010-10-21 PHASE1
NCT01276327 COMPLETED
Healthy
Boehringer Ingelheim
 2011-01 PHASE1
NCT01262963 COMPLETED
Cancer
GlaxoSmithKline
 2011-01-26 PHASE1
NCT00880321 COMPLETED
Cancer
GlaxoSmithKline
 2009-06-04 PHASE1
NCT00736099 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2008-08 PHASE3
NCT01216397 COMPLETED
Healthy
Boehringer Ingelheim
 2010-09 PHASE1
NCT01189201 COMPLETED
Healthy
Boehringer Ingelheim
 2010-08 PHASE1
NCT01012037 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2009-11 PHASE2
NCT00740051 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2008-08 PHASE3
NCT00935220 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2009-06 PHASE1
NCT02221401 COMPLETED
Healthy
Boehringer Ingelheim
 2010-01 PHASE1
NCT02220647 COMPLETED
Healthy
Boehringer Ingelheim
 2010-01 PHASE1
NCT02223026 COMPLETED
Healthy
Boehringer Ingelheim
 2010-01 PHASE1
NCT02221414 COMPLETED
Healthy
Boehringer Ingelheim
 2010-01 PHASE1
NCT02191228 COMPLETED
Renal Insufficiency
Boehringer Ingelheim
 2008-04 PHASE1
NCT02183636 COMPLETED
Healthy
Boehringer Ingelheim
 2009-08 PHASE1
NCT02183584 COMPLETED
Healthy
Boehringer Ingelheim
 2009-09 PHASE1
NCT02183480 COMPLETED
Healthy
Boehringer Ingelheim
 2009-07 PHASE1
NCT02172222 COMPLETED
Healthy
Boehringer Ingelheim
 2009-07 PHASE1
NCT00641043 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2008-03 PHASE3
NCT00621140 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2008-02 PHASE3
NCT00601250 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2008-01 PHASE3
NCT00602472 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2008-02 PHASE3
NCT00716092 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2008-07 PHASE2
NCT00309608 COMPLETED
Diabetes Mellitus, Type 2
Boehringer Ingelheim
 2006-04 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-26)

Check the Linagliptin product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Linagliptin selectively binds to dipeptidyl peptidase-4 with nanomolar affinity, blocking the enzymatic cleavage and inactivation of endogenous incretin hormones such as glucagon-like peptide-1. This sustained incretin activity stimulates glucose-dependent insulin secretion and suppresses inappropriate glucagon release, providing the physiological basis for improved glycemic control in patients with type 2 diabetes mellitus.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.