Drugs / Linagliptin
Linagliptin
also known as
BI 1356 · BI 1356 BS · Lina · Trajenta · - linagliptine (Trajenta). · A51R2 · linagliptine · Tradjenta · +1 more
targets DPP4 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed type 2 diabetes mellitus 1 milestone | |||||
| Filed | US (FDA) | — | type 2 diabetes mellitus | 2019-06-04 | “The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for the investigational fixed-dose combination tablet of empagliflozin, linagliptin and...” lilly.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (6) | US (FDA) | TRADJENTA | — | 2012-05-22 – 2023-06-20 | fda.gov ↗ |
| Approved | EU (EMA) | Trajenta | — | 2011-08-23 | europa.eu ↗ |
| Approved | US (FDA) | TRADJENTA | — | 2011-05-02 | fda.gov ↗ |
Trials 122 · started per year
today
US approved 2011
EU approved 2011
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 151 trials · 1 met primary · 1 missed | ||||||
| Phase 1 | NCT07034781 | Aug → Nov 2025 overdue | type 2 diabetes mellitus | AJU Pharm Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07044765 | Aug → Nov 2025 overdue | type 2 diabetes mellitus | AJU Pharm Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07039890 | Mar → May 2025 | type 2 diabetes mellitus | Humanis | Completed | No outcome recorded |
| Phase 1 | NCT05729386 | Feb → Apr 2023 | — | GC Biopharma Corp | Unknown | No outcome recorded |
| Phase 1 | NCT05703984 | Jan → Apr 2023 | — | GC Biopharma Corp | Unknown | No outcome recorded |
| Phase 1 | NCT05874180 | Jan → Feb 2023 | — | Dong Wha Pharmaceutical Co. Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05874167 | Aug → Oct 2022 | — | Dong Wha Pharmaceutical Co. Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04972539 | Aug → Nov 2020 | type 2 diabetes mellitus | AJU Pharm Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04970940 | Jul → Oct 2020 | type 2 diabetes mellitus | AJU Pharm Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05066516 | Jun → Aug 2020 | diabetes mellitus | Korea University Anam Hospital | Completed | No outcome recorded |
| Phase 1 | NCT03629054 | Aug → Nov 2018 | — | Boehringer Ingelheim | Completed | Met primary |
| Phase 1 | NCT03609294 | Jul 2018 → Mar 2019 | diabetes mellitus, hypertensive disorder | Boryung Pharmaceutical Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT03259490 | Aug → Nov 2017 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT03250052 | Aug → Oct 2017 | hypertensive disorder | Boryung Pharmaceutical Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT02821910 | Jul → Oct 2016 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02815644 | Jul → Oct 2016 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02212782 | Sep → Nov 2014 | — | Dong Wha Pharmaceutical Co. Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01943019 | Aug 2013 → Jul 2018 | schizophrenia | Monash University | Terminated | No outcome recorded |
| Phase 1 | NCT01703286 | Oct 2012 → Jan 2014 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | Missed primary |
| Phase 1 | NCT01540487 | Feb → Jun 2012 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01383356 | Jun → Dec 2011 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01216397 | Sep → Dec 2010 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01189201 | Aug → Nov 2010 | — | Boehringer Ingelheim | Completed | Mixed |
| Phase 1 | NCT02223026 | Jan → Mar 2010 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02183584 | Sep → Oct 2009 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02183636 | Aug → Dec 2009 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02183480 | Jul → Sep 2009 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02172222 | Jul → Sep 2009 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02183532 | Jul 2009 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT00935220 | Jun 2009 → Aug 2010 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02173639 | Apr → Jun 2009 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02183493 | Oct → Dec 2008 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02183376 | Jul 2008 → Mar 2009 | liver disorder | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02175394 | Jul → Oct 2008 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02183402 | Jun → Sep 2008 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02183389 | May → Oct 2008 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02183428 | May → Jul 2008 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02191228 | Apr 2008 → Feb 2010 | impaired renal function disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02183441 | Apr → Jun 2008 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02183467 | Jan → Jun 2008 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02183337 | Feb → Apr 2007 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02183363 | Feb → May 2007 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02183610 | Jul → Sep 2006 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02183311 | Jun → Oct 2006 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02183298 | May → Jul 2006 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02183623 | Sep → Oct 2005 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02183506 | Sep → Dec 2005 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02183415 | Aug 2005 → Jan 2006 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02180503 | Aug → Oct 2005 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02183350 | Apr → Aug 2005 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02173665 | Oct → Dec 2004 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT03337698 | Dec 2017 → Oct 2025 | non-small cell lung carcinoma | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 1/2 | NCT03281369 | Oct 2017 → Oct 2025 | digestive system carcinoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 26 trials · 4 met primary · 1 missed | ||||||
| Phase 2 | NCT01342484 | Apr 2011 → Feb 2016 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | Missed primary |
| Phase 2 | NCT01012037 | Nov 2009 → Sep 2010 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | Met primary |
| Phase 2 | NCT00716092 | Jul → Nov 2008 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | Met primary |
| Phase 2 | NCT02183324 | Feb → Jun 2007 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00328172 | May 2006 → Aug 2007 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | Met primary |
| Phase 2 | NCT00309608 | Apr 2006 → Aug 2007 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | Met primary |
| Phase 335 trials · 22 met primary · 2 missed | ||||||
| Phase 3 | NCT07852546 | Oct 2026 → Oct 2028 expected | poisoning | Tanta University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05641337 | Oct 2022 → Dec 2025 | cirrhosis of liver, diabetes mellitus | Huashan Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT06329674 | Apr 2021 → Dec 2022 | type 2 diabetes mellitus | AJU Pharm Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT04371978 | Oct 2020 → Apr 2021 | COVID-19, respiratory system disorder, type 2 diabetes mellitus | Rabin Medical Center | Terminated | Missed primary |
| Phase 3 | NCT04542213 | Aug 2020 → Feb 2021 | COVID-19, hyperglycemia | Hospital Regional de Alta Especialidad del Bajio | Completed | Met primary |
| Phase 3 | NCT04134650 | Sep 2019 → Jun 2020 | prediabetes syndrome | University of Guanajuato | Unknown | No outcome recorded |
| Phase 3 | NCT04131582 | Sep 2019 → Dec 2020 | prediabetes syndrome | University of Guanajuato | Unknown | No outcome recorded |
| Phase 3 | NCT03429543 | Mar 2018 → Oct 2022 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT02897349 | Sep 2016 → Jan 2019 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT02851745 | Jul 2015 → Jul 2019 | left ventricular failure, type 2 diabetes mellitus | Heart Care Foundation | Completed | Missed primary |
| Phase 3 | NCT02489968 | May 2015 → Nov 2016 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT02015299 | Mar 2014 → Jan 2016 | type 2 diabetes mellitus | dr. DJ Mulder | Completed | No outcome recorded |
| Phase 3 | NCT01968044 | Oct 2013 → Oct 2015 | — | LG Life Sciences | Completed | No outcome recorded |
| Phase 3 | NCT01792518 | Feb 2013 → Nov 2015 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT01778049 | Jan 2013 → Mar 2015 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT01708902 | Oct 2012 → Apr 2014 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01243424 | Nov 2010 → Aug 2018 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT01214239 | Oct 2010 → May 2012 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT01215097 | Oct 2010 → Apr 2012 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT01204294 | Sep 2010 → Jan 2012 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01087502 | Mar 2010 → May 2012 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT01084005 | Mar 2010 → Jun 2011 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT00996658 | Oct 2009 → Mar 2012 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT00954447 | Aug 2009 → Sep 2011 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT00915772 | Jun 2009 → Jun 2011 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT00798161 | Dec 2008 → May 2010 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT00800683 | Dec 2008 → Jan 2011 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT00740051 | Aug 2008 → Aug 2010 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT00736099 | Aug 2008 → Dec 2010 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT00654381 | Apr 2008 → Jan 2010 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT00641043 | Mar 2008 → Jun 2009 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT00622284 | Feb 2008 → Dec 2010 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT00602472 | Feb 2008 → May 2009 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT00621140 | Feb 2008 → May 2009 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT00601250 | Jan 2008 → May 2009 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | Met primary |
| Phase 423 trials · 5 met primary · 1 missed | ||||||
| Phase 4 | NCT06862739 | Oct 2025 → Apr 2026 overdue | type 2 diabetes mellitus | Nabiqasim Industries (Pvt) Ltd | Recruiting | No outcome recorded |
| Phase 4 | NCT06851962 | May 2025 → Jun 2026 | type 2 diabetes mellitus | Fundación para la Investigación del Hospital Clínico de Valencia | Completed | No outcome recorded |
| Phase 4 | NCT04341935 | Jun → Dec 2021 | COVID-19, type 2 diabetes mellitus | University of Miami | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT02768220 | Dec 2017 → Aug 2018 | diabetes mellitus | Northwell Health | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT03504566 | Nov 2017 → Jun 2019 | diabetic kidney disease | Steno Diabetes Center Copenhagen | Withdrawn | No outcome recorded |
| Phase 4 | NCT03433248 | Nov 2017 → Jun 2021 | type 2 diabetes mellitus | M.H.H. Kramer | Unknown | No outcome recorded |
| Phase 4 | NCT03320031 | Jun 2017 → Dec 2019 | type 2 diabetes mellitus | Yanbing Li | Unknown | No outcome recorded |
| Phase 4 | NCT04088461 | Sep 2016 → Sep 2018 | glucose intolerance, prediabetes syndrome | University of Guanajuato | Completed | Met primary |
| Phase 4 | NCT03004612 | Jan 2016 → May 2019 | prediabetes syndrome | University of Guanajuato | Completed | No outcome recorded |
| Phase 4 | NCT02312427 | Jan 2015 → Mar 2016 | congestive heart failure, diabetes mellitus | Mitsui Memorial Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02240680 | Sep 2014 → Apr 2017 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | Met primary |
| Phase 4 | NCT02280174 | Sep → Nov 2014 | type 2 diabetes mellitus | Ministry of Public Health, Argentina | Unknown | No outcome recorded |
| Phase 4 | NCT02061969 | Apr 2014 → Apr 2017 | type 2 diabetes mellitus | Emory University | Completed | No outcome recorded |
| Phase 4 | NCT02106104 | Mar 2014 → Apr 2016 | type 2 diabetes mellitus | Amsterdam UMC, location VUmc | Completed | No outcome recorded |
| Phase 4 | NCT02004366 | Jan 2014 → Feb 2017 | type 2 diabetes mellitus | Emory University | Completed | No outcome recorded |
| Phase 4 | NCT02097342 | Dec 2013 → Nov 2014 | type 2 diabetes mellitus | Post Graduate Institute of Medical Education and Research, Chandigarh | Unknown | No outcome recorded |
| Phase 4 | NCT01969084 | Oct 2013 → Jul 2016 | type 2 diabetes mellitus | Beth Israel Deaconess Medical Center | Completed | Missed primary |
| Phase 4 | NCT01903070 | Jul 2013 → Apr 2016 | diabetes mellitus | Profil Institute for Metabolic Research GmbH | Completed | No outcome recorded |
| Phase 4 | NCT01897532 | Jul 2013 → Jan 2018 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | Met primary |
| Phase 4 | NCT01617824 | Sep 2012 → Dec 2014 | chronic renal failure syndrome, type 2 diabetes mellitus | University of Padova | Completed | No outcome recorded |
| Phase 4 | NCT01547104 | Apr → Oct 2012 | type 2 diabetes mellitus | Marcus Borchert | Unknown | No outcome recorded |
| Phase 4 | NCT01512979 | Jan 2012 → Apr 2013 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | Met primary |
| Phase 4 | NCT01438814 | Nov 2011 → Mar 2013 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | Met primary |
| Phase not applicable5 trials | ||||||
| — | NCT05313529 | Oct 2022 → Dec 2025 overdue | cognitive impairment with or without cerebellar ataxia, type 2 diabetes mellitus | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Active not recruiting | No outcome recorded |
| — | NCT05032001 | Aug 2021 → Aug 2022 | abdominal obesity-metabolic syndrome, type 2 diabetes mellitus | Metabolic Research Unit | Unknown | No outcome recorded |
| — | NCT02608177 | Nov 2015 → Aug 2017 | chronic kidney disease, type 2 diabetes mellitus | University of Washington | Completed | No outcome recorded |
| — | NCT03222765 | Mar 2015 → Dec 2018 | prediabetes syndrome | Evidem Consultores SL | Unknown | No outcome recorded |
| — | NCT01974544 | May 2013 → Dec 2015 | type 2 diabetes mellitus | Pontificia Universidad Catolica de Chile | Unknown | No outcome recorded |
| Comparator or background therapy52 trials | ||||||
| Phase 1 | NCT01845077 Comparator | May → Aug 2013 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02173652 Comparator | Mar → Apr 2008 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT04662866 Comparator | Feb 2021 → Dec 2022 | glucose intolerance | Oslo University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT03986073 Comparator | Jan → Jun 2020 | type 2 diabetes mellitus | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT03667300 Comparator | Mar 2017 → May 2019 | impaired renal function disease, proteinuria, type 2 diabetes mellitus | Samsung Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT07635953 Comparator | Jul 2026 → Jul 2029 expected | diabetes mellitus | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06946628 Comparator | Jun 2025 → Dec 2028 expected | diabetes mellitus | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04670666 Comparator | Nov 2024 → Jul 2026 overdue | type 2 diabetes mellitus | EMS | Recruiting | No outcome recorded |
| Phase 3 | NCT05886088 Comparator | Feb 2024 → May 2026 overdue | type 2 diabetes mellitus | EMS | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04564872 Comparator | Nov 2020 → Jan 2022 | type 2 diabetes mellitus | Sichuan Haisco Pharmaceutical Group Co., Ltd | Completed | No outcome recorded |
| Phase 3 | NCT05290506 Comparator | Aug 2020 → Mar 2021 | prediabetes syndrome, type 2 diabetes mellitus | National University of Malaysia | Completed | No outcome recorded |
| Phase 3 | NCT03051243 Comparator | Oct 2017 → Nov 2018 | type 2 diabetes mellitus | Rabin Medical Center | Unknown | No outcome recorded |
| Phase 3 | NCT02752113 Comparator | Apr 2016 → Nov 2018 | type 2 diabetes mellitus | Institute for Pharmacology and Preventive Medicine | Completed | No outcome recorded |
| Phase 3 | NCT02453555 Comparator | May 2015 → Aug 2016 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT02077309 Comparator | Aug 2014 → Sep 2015 | type 2 diabetes mellitus | RWTH Aachen University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01888796 Comparator | Sep 2013 → Dec 2014 | diastolic heart failure, type 2 diabetes mellitus | RWTH Aachen University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01734785 Comparator | Feb 2013 → Mar 2015 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT02376075 Comparator | Jan 2013 → Sep 2014 | hypertensive disorder, proteinuria | ikfe-CRO GmbH | Completed | No outcome recorded |
| Phase 3 | NCT01835678 Comparator | Oct 2012 → Mar 2014 | type 2 diabetes mellitus | University of Erlangen-Nürnberg Medical School | Completed | No outcome recorded |
| Phase 3 | NCT01422876 Comparator | Aug 2011 → Sep 2013 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01194830 Comparator | Sep 2010 → Oct 2011 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01183013 Comparator | Aug 2010 → Feb 2013 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT00819091 Comparator | Dec 2008 → Jan 2010 | type 2 diabetes mellitus | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 4 | NCT07452913 Comparator | Jan → Mar 2026 overdue | type 2 diabetes mellitus | Bahria University | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT07442006 Comparator | Oct 2025 → Mar 2027 expected | type 2 diabetes mellitus | JW Pharmaceutical | Recruiting | No outcome recorded |
| Phase 4 | NCT07019012 Comparator | Jul 2025 → Oct 2026 expected | type 2 diabetes mellitus | Huazhong University of Science and Technology | Recruiting | No outcome recorded |
| Phase 4 | NCT06449235 Comparator | Sep 2024 → Apr 2025 overdue | type 2 diabetes mellitus | Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06449833 Comparator | Jun 2024 → Nov 2026 expected | NAFLD1, type 2 diabetes mellitus | Zhujiang Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT07247656 Comparator | Dec 2022 → Mar 2023 | type 2 diabetes mellitus | Bahria University | Completed | No outcome recorded |
| Phase 4 | NCT05200793 Comparator | Dec 2021 → Jul 2022 | polycystic ovary syndrome | Alexandria University | Unknown | No outcome recorded |
| Phase 4 | NCT03642184 Comparator | Jul 2018 → Jan 2019 | disease related to solid organ transplantation | RenJi Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03194945 Comparator | Nov 2017 → Dec 2022 | type 2 diabetes mellitus | Sun Yat-sen University | Completed | No outcome recorded |
| Phase 4 | NCT03458715 Comparator | Sep 2017 → Sep 2018 | type 2 diabetes mellitus | Mackay Memorial Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT03014479 Comparator | Feb → Oct 2017 | type 2 diabetes mellitus | Takeda | Completed | Missed primary |
| Phase 4 | NCT03011177 Comparator | Jan 2017 → Sep 2018 | type 2 diabetes mellitus | Handok Inc. | Completed | No outcome recorded |
| Phase 4 | NCT02974504 Comparator | Sep 2016 → Mar 2018 | type 2 diabetes mellitus | Dong-A ST Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT02429232 Comparator | Oct 2015 → Jul 2017 | osteoporosis, type 2 diabetes mellitus | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02528019 Comparator | Aug 2015 → Aug 2017 | — | Kurume University | Unknown | No outcome recorded |
| Phase 4 | NCT02401880 Comparator | May → Dec 2015 | type 2 diabetes mellitus | Profil Institute for Metabolic Research GmbH | Completed | No outcome recorded |
| Phase 4 | NCT02467478 Comparator | Apr 2015 → Apr 2019 | impaired renal function disease, type 2 diabetes mellitus | George Washington University | Completed | No outcome recorded |
| Phase 4 | NCT02442817 Comparator | Mar 2015 → Mar 2018 | schizophrenia | University of Nevada, Reno | Completed | No outcome recorded |
| Phase 4 | NCT02180334 Background | Jul → Nov 2014 | type 2 diabetes mellitus | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02372630 Comparator | May 2014 → Feb 2018 | type 2 diabetes mellitus | University at Buffalo | Completed | No outcome recorded |
| Phase 4 | NCT02041234 Comparator | Feb 2014 → Dec 2020 | type 2 diabetes mellitus | Khoo Teck Puat Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02072096 Background | Feb 2014 → Oct 2015 | type 2 diabetes mellitus | Eli Lilly and Company | Terminated | Missed primary |
| Phase 4 | NCT02092597 Comparator | Oct 2013 → Oct 2015 | type 2 diabetes mellitus | Charles University, Czech Republic | Completed | No outcome recorded |
| Phase 4 | NCT02350478 Comparator | Jul 2013 → Jan 2017 | coronary artery disorder, type 2 diabetes mellitus | Medical University of Graz | Completed | No outcome recorded |
| — | NCT06098625 Comparator | Nov 2023 → Jul 2025 | diabetes mellitus | Medanta, The Medicity, India | Unknown | No outcome recorded |
| — | NCT06095492 Comparator | Oct 2023 → Oct 2025 overdue | diabetes mellitus | Medanta, The Medicity, India | Recruiting | No outcome recorded |
| — | NCT02792400 Comparator | May → Aug 2016 | type 2 diabetes mellitus | University Hospital, Gentofte, Copenhagen | Completed | No outcome recorded |
| — | NCT02244164 Comparator | Oct 2014 → Feb 2023 | type 2 diabetes mellitus | Erasme University Hospital | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT02725502 Comparator | Jul 2013 → Apr 2016 | type 1 diabetes mellitus | Post Graduate Institute of Medical Education and Research, Chandigarh | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 38
| Date | Issuer | Release |
|---|---|---|
| 2020-01-27 | Eli Lilly and Company | Regulatory US FDA approves only triple-combination tablet with Jardiance® for adults with type 2 diabetes lilly.com ↗
The U.S. Food and Drug Administration (FDA) has approved Trijardy™ XR (empagliflozin/linagliptin/metformin hydrochloride extended release tablets) to lower blood sugar in adults with type 2 diabetes, along with diet and exercise. |
| 2019-06-10 | Eli Lilly and Company | Results Detailed findings from CAROLINA® outcome trial support long-term cardiovascular safety profile of Tradjenta® lilly.com ↗
Tradjenta was similar to glimepiride in the secondary endpoint of 3P-MACE plus hospitalization for unstable angina (4P-MACE) (13.2% for Tradjenta versus 13.3% for glimepiride). |
| 2019-06-04 | Eli Lilly and Company | Regulatory U.S. FDA Accepts New Drug Application for Triple Combination Tablet for Adults with Type 2 Diabetes lilly.com ↗
The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for the investigational fixed-dose combination tablet of empagliflozin, linagliptin and metformin extended release (XR) for the treatment of adults with type 2 diabetes, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced. |
| 2019-02-14 | Eli Lilly and Company | Results Boehringer Ingelheim and Lilly announce the CAROLINA® cardiovascular outcome trial of Tradjenta® met its primary endpoint of non-inferiority compared with glimepiride lilly.com ↗ |
| 2018-11-29 | Zydus Lifesciences Limited | Regulatory Zydus receives approvals from the USFDA for Lansoprazole Tablets and Linagliptin tablets zyduslife.com ↗
Zydus Cadila has received the final approval from the USFDA to market Lansoprazole delayed release orally disintegrating tablets (US RLD - Prevacid), 15 mg and 30 mg and tentative approval for Linagliptin tablets (US RLD- Tradjenta), 5 mg. |
| 2018-10-04 | Eli Lilly and Company | Results Boehringer Ingelheim and Lilly present full results of Tradjenta®'s CARMELINA® cardiovascular outcome trial lilly.com ↗
The study met its primary endpoint, with Tradjenta demonstrating a similar cardiovascular safety profile compared with placebo when added to standard of care. |
| 2018-07-19 | Eli Lilly and Company | Results Boehringer Ingelheim and Lilly announce Tradjenta's CARMELINA® cardiovascular outcome trial meets primary endpoint lilly.com ↗
CARMELINA® (CArdiovascular safety and Renal Microvascular outcomE with LINAgliptin in patients with type 2 diabetes at high vascular risk) met its primary endpoint, defined as time to first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke (3-point MACE), with Tradjenta® demonstrating similar cardiovascular safety compared with placebo. |
| 2016-06-11 | Eli Lilly and Company | Results New study results show Tradjenta® (linagliptin) reduces blood sugar in adults with type 2 diabetes at risk for kidney impairment lilly.com ↗ |
| 2016-05-31 | Eli Lilly and Company | Regulatory U.S. FDA Approves Once-daily Jentadueto® XR (linagliptin and metformin hydrochloride extended-release) Tablets for Adults with Type 2 Diabetes lilly.com ↗
The U.S. Food and Drug Administration (FDA) has approved Jentadueto® XR (linagliptin and metformin hydrochloride extended-release) tablets for the treatment of type 2 diabetes (T2D) in adults. |
| 2015-02-02 | Eli Lilly and Company | Regulatory U.S. FDA approves first-in-class Glyxambi® (empagliflozin/linagliptin) tablets for adults with type 2 diabetes lilly.com ↗
The U.S. Food and Drug Administration (FDA) has approved Glyxambi® (empagliflozin/linagliptin) tablets, from Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company (NYSE: LLY), as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D) when both empagliflozin and linagliptin are appropriate treatments. |
| 2014-08-04 | Eli Lilly and Company | Results Type 2 diabetes: Jentadueto® (linagliptin and metformin hydrochloride) tablets label updated to include new data on blood glucose reductions in treatment-naive adults with high baseline A1C lilly.com ↗
The U.S. Prescribing Information for Jentadueto® (linagliptin and metformin hydrochloride) tablets now includes clinical trial data that showed linagliptin co-administered with metformin provided statistically significant decreases in blood glucose compared with linagliptin alone in treatment-naive* adults with type 2 diabetes and high baseline A1C levels (A1C of > /=8.5 to < /=12.0 percent). |
| 2014-06-15 | Eli Lilly and Company | Results Type 2 Diabetes: Investigational Empagliflozin/Linagliptin Combination Tablet Showed Reduction in Blood Glucose in Two Phase III Trials lilly.com ↗
Two phase III clinical trials found the investigational combination tablet of empagliflozin and linagliptin reduced blood glucose levels in adults with type 2 diabetes (T2D), Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company (NYSE: LLY) announced. |
| 2014-06-09 | Eli Lilly and Company | Results Diabetes: Boehringer Ingelheim and Eli Lilly and Company Alliance to Feature 43 Presentations at the 74th American Diabetes Association Scientific Sessions® lilly.com ↗
Oral glucose lowering with linagliptin plus metformin is a viable initial treatment strategy in patients with newly diagnosed type 2 diabetes (T2D) and marked hyperglycemia |
| 2014-05-15 | Eli Lilly and Company | Results Type 2 diabetes: findings presented from retrospective analysis of pooled data examining linagliptin in African-American adults lilly.com ↗
Additionally, similar proportions of patients in the linagliptin and placebo groups experienced adverse events, including the incidence of investigator-reported hypoglycemia. |
| 2014-04-14 | Eli Lilly and Company | Regulatory Boehringer Ingelheim and Eli Lilly and Company Announce New Drug Application Filing in the U.S. for the Combination Tablet of Empagliflozin and Linagliptin lilly.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (Lilly; NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) accepted the filing of the New Drug Application (NDA) |
| 2013-09-24 | Eli Lilly and Company | Results Data From Post-Hoc Analyses Presented at EASD Examine Safety Profile of Linagliptin in Adults with Type 2 Diabetes lilly.com ↗
Boehringer Ingelheim and Eli Lilly and Company (Lilly; NYSE: LLY) today announced results from two post-hoc, pooled analyses of data from placebo-controlled clinical trials, which examined the safety of the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin in adults with type 2 diabetes (T2D). |
| 2013-08-15 | Eli Lilly and Company | Results Linagliptin Demonstrated Significant HbA1c Reduction in Elderly People With Type 2 Diabetes With Inadequate Glycemic Control lilly.com ↗
In addition, the overall safety and tolerability profile of linagliptin was similar to placebo. |
| 2013-06-25 | Eli Lilly and Company | Results Results of cardiovascular post-hoc meta-analysis examining CV events in adults with type 2 diabetes treated with linagliptin presented at ADA lilly.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) today announced results from a new pooled analysis of phase III data for the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin. |
| 2013-06-22 | Eli Lilly and Company | Results Results of new exploratory analyses assessing the incidence of hypoglycemia with linagliptin in adults with type 2 diabetes announced lilly.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) today announced results from two exploratory analyses assessing the risk of hypoglycemia with linagliptin treatment in adults with type 2 diabetes (T2D). |
| 2013-06-22 | Eli Lilly and Company | Results Phase III studies show linagliptin improved blood glucose control in Asian adults with type 2 diabetes lilly.com ↗ |
| 2013-06-22 | Eli Lilly and Company | Results New data about the safety and efficacy of linagliptin in adults with type 2 diabetes who have moderate to severe renal impairment presented at ADA lilly.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) today announced results from a new study in which linagliptin demonstrated statistically significant reductions in blood glucose levels (HbA1c) after 12 weeks (the study's primary endpoint) in adults with type 2 diabetes (T2D) with moderate to severe renal impairment, compared with placebo. |
| 2013-06-20 | Eli Lilly and Company | Regulatory Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company Announce Updates to Prescribing Information for TRADJENTA® (linagliptin) Tablets and JENTADUETO® (linagliptin and metformin hydrochloride) Tablets lilly.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) announce the U.S. Food and Drug Administration (FDA) has approved updates to the full U.S. Prescribing Information (PI) for TRADJENTA® (linagliptin) tablets and JENTADUETO® (linagliptin and metformin hydrochloride) tablets. |
| 2013-06-11 | Eli Lilly and Company | Results Boehringer Ingelheim and Eli Lilly and Company Alliance to Feature 34 Presentations on Type 1 and Type 2 Diabetes at the 73rd American Diabetes Association Scientific Sessions® lilly.com ↗
Linagliptin improved glycemic control without weight gain or hypoglycemia in patients with type 2 diabetes inadequately controlled by a combination of metformin and pioglitazone |
| 2013-05-06 | Eli Lilly and Company | Results Retrospective analysis of linagliptin data in sub-populations with type 2 diabetes presented at AACE 22nd Annual Scientific & Clinical Congress lilly.com ↗
Data pooled from six phase III studies showed that treatment with linagliptin reduced glucose levels (HbA1c) versus placebo in this patient population. |
| 2012-10-02 | Eli Lilly and Company | Results Studies assess linagliptin treatment in adults with type 2 diabetes (T2D), as well as add-on to basal insulin therapy lilly.com ↗
The new analyses show linagliptin, alone or in combination with other diabetes therapies, lowered hemoglobin A1c (HbA1c or A1C) in elderly patients with type 2 diabetes, as well as in adults with type 2 diabetes with diabetic nephropathy (renal disease). |
| 2012-08-17 | Eli Lilly and Company | Regulatory FDA approves updated prescribing information for Tradjenta® (linagliptin) tablets for add-on therapy to insulin in adults with type 2 diabetes lilly.com ↗
today announced the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Tradjenta® (linagliptin) tablets for use as add-on therapy to insulin. |
| 2012-06-09 | Eli Lilly and Company | Results Post-hoc analysis of linagliptin phase 3 data in adults with type 2 diabetes and albuminuria presented lilly.com ↗
The post-hoc analysis showed a 29 percent reduction in UACR with linagliptin plus ACE/ARBs, versus ACE/ARBs alone at 24 weeks (p=0.0305). |
| 2012-06-09 | Eli Lilly and Company | Results Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company present new linagliptin data at American Diabetes Association's 72nd Scientific Sessions® lilly.com ↗
After 104 weeks of treatment, both linagliptin and glimepiride reduced mean A1C levels by 0.6 percent from baseline (baseline: 7.2 percent linagliptin, 7.3 percent glimepiride) and 76 percent of patients in both groups achieved target A1C < 7 percent. |
| 2012-05-24 | Eli Lilly and Company | Results New Phase 3 data for Tradjenta® (linagliptin) tablets in black or African American patients with type 2 diabetes showed significant improvement in blood sugar lilly.com ↗ |
| 2011-08-25 | Eli Lilly and Company | Regulatory Linagliptin Receives Approval in Europe for the Treatment of Type 2 Diabetes lilly.com ↗
Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today received Marketing Authorization from the European Commission for linagliptin 5 mg film-coated tablets (to be marketed under the trade name Trajenta® in Europe) for the treatment of adults with type 2 diabetes. |
| 2011-06-24 | Eli Lilly and Company | Results Two-Year Data Comparing Cardiovascular Events with Linagliptin and the Sulfonylurea, Glimepiride, Presented as Late-Breaking Poster at ADA lilly.com ↗
twice as many patients taking glimepiride (26 patients) experienced CV events compared to those taking linagliptin (12 patients), demonstrating a 50 percent reduction in relative risk for the combined CV endpoint |
| 2011-06-24 | Eli Lilly and Company | Results New Phase III Data and Pooled Analysis for Linagliptin Show Improved Blood Sugar Control in Adults With Type 2 Diabetes When Used Alone and With Metformin lilly.com ↗
Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announce Phase III study results for linagliptin, demonstrating improved glycemic control in adults with type 2 diabetes (T2D) whose blood sugar is not adequately controlled. |
| 2011-06-24 | Eli Lilly and Company | Regulatory Linagliptin recommended for approval in the treatment of type 2 diabetes in Europe lilly.com ↗
Linagliptin is also recommended for approval in combination with metformin and metformin plus sulfonylurea. |
| 2011-06-20 | Eli Lilly and Company | Results Boehringer Ingelheim and Lilly to Feature Type 2 Diabetes Research in More Than 25 Presentations at the 71st American Diabetes Association Scientific Sessions lilly.com ↗
Linagliptin has Improved Safety and Similar Efficacy to Glimepiride over 2 Years in Patients with Type 2 Diabetes Mellitus Inadequately Controlled on Metformin |
| 2011-05-02 | Eli Lilly and Company | Regulatory Video: FDA Approves Tradjenta™ (linagliptin) Tablets for the Treatment of Type 2 Diabetes lilly.com ↗ |
| 2010-09-22 | Boehringer Ingelheim | Results Boehringer Ingelheim Presents New Phase III Data Evaluating Linagliptin in People with Type 2 Diabetes prnewswire.com ↗
In addition, new pharmacokinetic (PK) data demonstrate that decreases in renal function had minor effect on the elimination of linagliptin.(3) |
| 2010-06-28 | Boehringer Ingelheim | Results Boehringer Ingelheim Announces Pivotal Phase III Data Showing Linagliptin Reduced Blood Sugar Compared to Placebo in People With Type 2 Diabetes prnewswire.com ↗
Data from four pivotal Phase III clinical trials demonstrate that linagliptin achieved statistically significant and sustained reductions in blood sugar as measured by hemoglobin A1c (HbA1c),(1-4) fasting plasma glucose (FPG)(1-4) and postprandial glucose (PPG).(1,2) |
| 2010-06-26 | Boehringer Ingelheim | Results Boehringer Ingelheim Announces Pivotal Phase III Data Showing Linagliptin Reduced Blood Sugar Compared to Placebo in People With Type 2 Diabetes prnewswire.com ↗
Data from four pivotal Phase III clinical trials demonstrate that linagliptin achieved statistically significant and sustained reductions in blood sugar as measured by hemoglobin A1c (HbA1c),(1-4) fasting plasma glucose (FPG)(1-4) and postprandial glucose (PPG).(1,2) |
All press releases naming this drug 48 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 181 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Linagliptin | “The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (BI 1356) (5 mg or 10 mg / once daily) compared to placebo given for...” NCT00654381 ↗148“A total of 235 patients with inadequate response to metformin (≥1000 mg/day) plus linagliptin (5 mg/day) were randomized to receive either dapagliflozin/linagliptin fixed-dose...” PMID 39375869 ↗ Oct 2024 “To investigate the influence of mild, moderate, and severe liver impairment on the pharmacokinetics and pharmacodynamics of linagliptin in comparison with a control group with...” NCT02183376 ↗ “A Randomised, Double-blind, Placebo-controlled, Parallel Group Dose-finding Study of Linagliptin (1 and 5 mg Administered Orally Once Daily) Over 12 Weeks in Children and...” NCT01342484 ↗ “Subsequently, those with HbA1c ≥7.0 and ≤10.5% (>53 and ≤91 mmol/mol) (N = 482) were randomized to 24 weeks' double-blind, double-dummy treatment with linagliptin 5 mg or...” PMID 27762093 ↗ Nov 2016 “The hypoglycemic scheme of the experimental group was that the initial dose of Insulin Degludec and Insulin Aspart was 0.3U/kg multiplied by the patient's weight, plus 5 mg of...” NCT05641337 ↗ “patients with inadequately controlled T2DM on SU monotherapy were randomly assigned to receive treatment with linagliptin 5 mg once daily (n = 161) or placebo (n = 84) for 18 weeks.” PMID 22939034 ↗ Aug 2012 “DPP-4 inhibitor (sitagliptin, vildagliptin, alogliptin, linagliptin, teneligliptin, anagliptin or saxagliptin) will be suspended for one month and serum BNP will be measured.” NCT02312427 ↗ “Chemical Names: Sitagliptin, Vildagliptin, Saxagliptin, Linagliptin, Alogliptin Class: Dipeptidyl Peptidase-4 (DPP-4) Inhibitors” NCT06449235 ↗ “A Pharmacokinetic Study of DW6013 (FDC of Linagliptin and Metformin) in Healthy Adult Volunteers in Fed Condition” NCT05874180 ↗ “Single oral dose A51R1(Dapagliflozin) 10 mg tablet and A51R2(Linagliptin) 5 mg tablet taken together” NCT04972539 ↗ |
| Known as | - linagliptine (Trajenta). | “- linagliptine (Trajenta®).” NCT02244164 ↗ |
| Known as | A51R2 | “Single oral dose A51R1(Dapagliflozin) 10 mg tablet and A51R2(Linagliptin) 5 mg tablet taken together” NCT04972539 ↗ |
| Known as | BI 1356 | “The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (BI 1356) (5 mg or 10 mg / once daily) compared to placebo given for...” NCT00654381 ↗27“An Open Label, Phase I Trial to Investigate the Pharmacokinetics and Pharmacodynamics of Linagliptin (BI 1356) 5 mg After Single and Multiple Oral Administration” NCT00935220 ↗ “Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes” NCT00601250 ↗ “Efficacy and Safety of BI 1356 (Linagliptin) Versus Placebo in Type 2 Diabetic Patients With Insufficient Glycemic Control” NCT00621140 ↗ “Efficacy and Safety of Linagliptin (BI 1356) in Black/African Americans With Type 2 Diabetes With a MTT Sub-study” NCT01194830 ↗ “The Effect of Linagliptin (BI 1356) on 24h-glucose Control and Various Biomarkers in Type 2 Diabetic Patients” NCT00716092 ↗ “Safety and Efficacy of Linagliptin (BI 1356) Plus Metformin in Type 2 Diabetes, Factorial Design” NCT00798161 ↗ “Efficacy and Safety of 3 Doses of BI1356 (Linagliptin) in Type 2 Diabetes Patients” NCT00328172 ↗ “5 mg linagliptin (BI 1356)/45 mg pioglitazone fixed dose combination” NCT02183636 ↗ “BI 1356 (Linagliptin) (5 mg / once daily)” NCT00641043 ↗ “BI1356 low dose” NCT01342484 ↗ |
| Known as | BI 1356 BS | “Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin” NCT00309608 ↗ |
| Known as | Lina | “This double-blind, randomized, placebo-controlled trial (ClinicalTrials.gov NCT02453555) evaluated the efficacy and safety of empagliflozin (Empa) 10 or 25 mg as add-on to...” PMID 29766636 ↗ Jun 20181“evaluated the efficacy and safety of empagliflozin (Empa) 10 or 25 mg and linagliptin (Lina) 5 mg fixed-dose combinations (FDCs) in Japanese patients with type 2 diabetes...” PMID 30091172 ↗ Sep 2018 |
| Known as | linagliptine | “- linagliptine (Trajenta®).” NCT02244164 ↗ |
| Known as | Tradjenta | “5 mg Linagliptin (Tradjenta)” NCT01845077 ↗ |
| Known as | Trajenta | “each group was administered either a single dose of IN-C009 (FCDP, dapagliflozin 10mg/linagliptin 5 mg) (HK inno.N., Seoul, Korea) or co-administration of a single dose of...” NCT05066516 ↗1“AJU-A51R2: Trajenta 1 Tab., Q.D., single dose, for 11 days” NCT04970940 ↗ |
| Known as | Trajenta (Linagliptin) | “Trajenta (Linagliptin)” NCT03051243 ↗ |
| Action | Inhibit | “the dipeptidyl peptidase-4 inhibitor linagliptin” PMID 21781152 ↗ Nov 2011 |
| Modality | Small molecule | “the dipeptidyl peptidase-4 inhibitor linagliptin” PMID 24169807 ↗ Oct 2013 |
| Route | Oral | “1 mg, 5 mg and 10 mg Administered Orally Once Daily” NCT00309608 ↗ |
| Target | DPP4 | “the dipeptidyl peptidase (DPP)-4 inhibitor linagliptin versus comparator treatments” PMID 22234149 ↗ Jan 2012 |