Effectiveness and Safety of Cofrogliptin and Linagliptin as add-on Therapy to Insulin in Chinese Adults With Type 2 Diabetes Mellitus: a Multicenter, Prospective Real-world Study (COLOR-REAL)

This study is a multicenter, prospective, non-interventional real-world study to evaluate the clinical outcomes of biweekly cofrogliptin versus daily linagliptin as an add-on therapy in Chinese adult T2D patients.

Start Date01 Oct 2025

Sponsor / Collaborator

Sun Yat-Sen University

TCTR20241208004

/ Not yet recruitingPhase 1IIT

A Bioequivalence study of a randomized, single dose, two-way crossover design with two-period, two-treatment and two-sequence of AUROLENA 5 (Linagliptin Tablets 5 mg) relative toTRAJENTA film-coated tablets 5 mg in healthy Thai adult volunteers under fasting condition

Start Date25 Sep 2025

Sponsor / Collaborator

Bio-innova Co., Ltd

TCTR20250216006

/ Not yet recruitingPhase 1IIT

A Bioequivalence study of a randomized, open-label, single dose, two-way crossover design with two-period, two-treatment and two-sequence of Linagliptin 2.5 mg and Metformin 500 mg Film-coated Tablets relative to Trajenta Duo in Thai healthy volunteers under fed condition

Start Date05 Aug 2025

Sponsor / Collaborator

Bio-innova Co., Ltd

100 Clinical Results associated with Linagliptin

100 Translational Medicine associated with Linagliptin

100 Patents (Medical) associated with Linagliptin

1,509

Literatures (Medical) associated with Linagliptin

01 Dec 2025·American journal of medicine open

The Association of SGLT2i vs DPP4i on Fracture: A Cohort Study in Veterans with Diabetes

Article

Author: Hackstadt, Amber ; Griffin, Katherine ; Javid, Amir ; Hung, Adriana ; Snyder, Kathryn ; Roumie, Christianne L ; Greevy, Robert

Background:

Increased bone turnover is associated with use of SGLT2i. Patients with diabetes experience adverse effects on bone metabolism. Our aim was to evaluate if SGLT2i was associated with fractures vs DPP4i as add-on therapy to diabetes regimens.

Methods:

We assembled a retrospective cohort of Veterans with diabetes combining Veterans Administration, Medicare, and National Death Index databases. Using an active comparator new user design, patients starting on SGLT2i or DPP4i were followed from prescription fill until a fracture event, death, stopping medication, loss of follow-up, or study end. Fractures included: face/skull, spine, ribs, long bones, hand/feet/digits, or hip. Fractures were identified based on a validated algorithm with positive predictive value 91.3% (86.8, 94.4). Cox models compared the association of fractures between SGLT2i and DPP4i in a propensity score-weighted cohort that balanced 70+ covariates including comorbidities, vital signs, labs, vitamin D levels, smoking, and medications.

Results:

The unweighted sample included 115,124 SGLT2i episodes (104,086 Veterans; 94% empagliflozin; 4% canagliflozin; 2% dapagliflozin) and 213,095 DPP4i episodes (173,724 Veterans; 45% saxagliptin; 15% sitagliptin; 34% alogliptin; 6% Linagliptin). After propensity score calculation and matched weighting, the cohort included 76,072 SGLT2i and 75,833 DPP4i episodes. Median age was 69.3 years and diabetes duration 9.7 (6.1, 14.0) years. In the matched weighted analyses, there were 1431 and 1564 fractures among SGLT2i and DPP4i users, respectively. There were no clinical differences in fractures per 1000 person-years: 18.2 (17.4, 19.1) vs 19.8 (19.0, 20.6). The adjusted hazard ratio (adjusted hazard ratio 0.93 [0.87, 0.99]) excluded increased risk of fractures (adjusted hazard ratio > 1) in SGLT2i users.

Conclusions:

SGLT2i use as add-on treatment for diabetes was not associated with increased fracture outcomes compared to DPP4i.

01 Nov 2025·TALANTA

Erratum to ‘Simultaneous enantiomeric separation of linagliptin and clopidogrel by capillary electrophoresis for the individual, combined, and enantiomeric ecotoxicity evaluation on Pseudokirchneriella subcapitata’ [Talanta (September 2025) 127992]

Author: García, María Ángeles ; Marina, María Luisa ; Boltes, Karina ; García-Cansino, Laura

01 Nov 2025·NEUROPHARMACOLOGY

Early treatment with vildagliptin and linagliptin reduces social fear and prevents the onset of comorbid depression in a mouse model of social anxiety disorder

Article

Author: Kornhuber, Johannes ; Zoicas, Iulia

We have previously shown that sitagliptin, a widely used dipeptidyl peptidase-4 (DPP4) inhibitor for the treatment of type 2 diabetes mellitus, effectively reduces social fear in an animal model that closely mimics the main behavioral symptoms of social anxiety disorder (SAD). This social fear conditioning (SFC) model induces social fear without comorbidities in the short term, but over time, a depressive-like phenotype emerges, mimicking the comorbidity often observed in SAD patients. In this study, we investigated the effects of two DPP4 inhibitors, vildagliptin and linagliptin, both of which have distinct pharmacokinetic profiles compared to sitagliptin, on social fear and the prevention of comorbid depressive-like behavior. We show that administration of vildagliptin (50 mg/kg/day and 100 mg/kg/day) and linagliptin (5 mg/kg/day and 10 mg/kg/day) via the drinking water significantly reduced social fear in male CD1 mice subjected to SFC. Importantly, both gliptins also prevented the onset of comorbid depressive-like behavior in these mice. These results have important clinical connotations, as they suggest that early treatment with DPP4 inhibitors such as sitagliptin, vildagliptin and linagliptin could serve as promising therapeutic strategy for SAD, not only reducing the main symptoms of social anxiety but also the risk of developing comorbid mood disorders that often exacerbate the severity of symptoms and complicate treatment outcomes.

News (Medical) associated with Linagliptin

29 Aug 2025

·www.einpresswire.com

July - September 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Ajovy (fremanezumab-vfrm) Emgality (galcanezumab-gnlm) Nurtec ODT (rimegepant) Ubrelvy (ubrogepant) Vyepti (eptinezumab-jjmr) Hypertension The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2025 to include information about the risk of hypertension. Example: Ajovy labeling Apriso (mesalamine) Asacol (mesalamine) Asacol HD (mesalamine) Azulfidine (sulfasalazine) Azulfidine EN-Tabs (sulfasalazine) Canasa (mesalamine) Colazal (balsalazide disodium) Delzicol (mesalamine) Dipentum (osalazine sodium) Giazo (balsalazide disodium) Lialda (mesalamine) Rowasa (mesalamine) Pentasa (mesalamine) Severe cutaneous adverse reactions The Warnings and Precautions section of the labeling was updated November 2021 to include severe cutaneous adverse reactions. Example: Delzicol labeling Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Pancreatitis FDA determined that no action is necessary at the time based on available information. Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Anaphylactic shock The "Warnings and Precautions" section of the labeling was updated between September 2022 and February 2023 to include anaphylactoid/anaphylactic reactions. Example: Avastin labeling Ayvakit (avapritinib) Photosensitivity reaction The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2023 to include information about photosensitivity. Ayvakit labeling Azacitidine Onureg (azacitidine) Vidaza (azacitidine) Generic products containing azacitidine Pericarditis The "Adverse Reactions" section of the labeling was updated between September 2022 and June 2023 to include pericarditis. Example: Vidaza labeling FDA determined that no action is necessary at the time based on available information for Onureg. Bavencio (avelumab) Imfinzi (durvalumab) Libtayo (cemiplimab-rwlc) Keytruda (pembrolizumab) Opdivo (nivolumab) Tecentriq (atezolizumab) Yervoy (ipilimumab) Tumour lysis syndrome FDA determined that no action is necessary at the time based on available information. Cymbalta (duloxetine hydrochloride) Drizalma Sprinkle (duloxetine hydrochloride) Generic products containing duloxetine hydrochloride Anosmia, Hyposmia This issue is posted as two individual newly identified safety signal (NISS) entries in the January-March 2022 quarter, to reflect the focus on the potential signals of anosmia and hyposmia, separately. Darzalex (daratumumab) Darzalex Faspro (daratumumab and hyaluronidase-fihj) Blood stem cell transplant failure FDA determined that no action is necessary at the time based on available information. Dipeptidyl peptidase-4 (DPP-4) inhibitors Glyxambi (empagliflozin and linagliptin) Janumet (metformin hydrochloride and sitagliptin phosphate) Janumet XR (metformin hydrochloride and sitagliptin phosphate) Jentadueto (linagliptin and metformin hydrochloride) Jentadueto XR (linagliptin and metformin hydrochloride) Kazano (alogliptin and metformin hydrochloride) Kombiglyze XR (metformin hydrochloride and saxagliptin) Nesina (alogliptin) Onglyza (saxagliptin) Oseni (alogliptin and pioglitazone) Steglujan (ertugliflozin and sitagliptin) Tradjenta (linagliptin) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Qtern (saxagliptin and dapagliflozin) Generic products containing dipeptidyl peptidase-4 inhibitors Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated between March 2022 and June 2022 for products containing alogliptin and sitagliptin to include tubulointerstitial nephritis. Example: Janumet labeling FDA determined that no action is necessary for products containing linagliptin and saxagliptin at the time based on available information. *An administrative error resulted in the omission of Januvia from the list of product names after the initial quarterly report was posted. Dupixent (dupilumab) Angioedema The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include angioedema. Dupixent labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua 100/33 (insulin glargine and lixisenatide injection) Trulicity (dulaglutide) Victoza (liraglutide) Wegovy (semaglutide) Xultophy 100/3.6 (insulin degludec and liraglutide injection) Generic products containing glucagon-like peptide-1 analogues Gallbladder related disorders The "Warnings and Precautions", "Adverse Reactions", and "Patient Counseling Information" sections of the GLP-1 analogues labeling were updated between March 2022 and June 2022 to include information about acute gallbladder disease. Example: Adlyxin labeling FDA has determined that the last approved labeling for Saxenda and Wegovy is adequately labeled for acute gallbladder disease, and that no further regulatory action is needed at this time. Gonadotropin releasing hormone (GnRH) analogues Fensolvi (leuprolide acetate) Lupron Depot-PED (leuprolide acetate) Supprelin LA (histrelin acetate) Synarel (nafarelin acetate) Triptodur (triptorelin) Idiopathic intracranial hypertension The "Warnings", "Precautions", and "Adverse Reactions" sections of the labeling were updated in April 2022 to include idiopathic intracranial hypertension. Example: Fensolvi labeling Jakafi (ruxolitinib phosphate) Herpes simplex virus (HSV) reactivation and/or disseminated HSV The "Dosage and Administration", "Warnings and Precautions", and "Adverse Reactions" sections of the labeling were updated in January 2023 to include information about herpes simplex and herpes zoster infections. Jakafi labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Embolic and thrombotic events, venous The "Adverse Reactions" section of the Ibrance labeling was updated in December 2024 to include venous thromboembolism. Ibrance labeling FDA determined that no action is necessary at the time for Kisqali and Kisqali Femara Co-Pack based on available information. Ocrevus (ocrelizumab) Myocardial infarction FDA determined that no action is necessary at the time based on available information. Potassium Chloride Product preparation error The “Warnings” section of the labeling was updated in December 2022 to include information about fatal cardiac adverse reactions with intravenous administration of undiluted potassium chloride. Praxbind (idarucizumab) Wrong dose errors The carton labeling and "Dosage and Administration" sections of the labeling were revised in February 2022 to clarify the number of vials included in each carton and the recommended dosing. Praxbind labeling Qbrexza (glycopyrronium tosylate) Accidental exposure to product The container label, carton labeling, "Dosage and Administration", "Warnings and Precautions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in October 2022 to include information about accidental exposure. Qbrexza labeling Qbrexza (glycopyrronium tosylate) Urinary retention The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in October 2022 to include information about new or worsening urinary retention. Qbrexza labeling Sodium-glucose cotransporter-2 (SGLT-2) inhibitors Farxiga (dapagliflozin) Glyxambi (empagliflozin and linagliptin) Invokamet (canagliflozin and metformin hydrochloride) Invokamet XR (canagliflozin and metformin hydrochloride) Invokana (canagliflozin) Jardiance (empagliflozin) Qtern (saxagliptin and dapagliflozin) Steglatro (ertugliflozin) Steglujan (ertugliflozin and sitagliptin) Segluromet (ertugliflozin and metformin hydrochloride) Synjardy (empagliflozin and metformin hydrochloride) Synjardy XR (empagliflozin and metformin hydrochloride) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Xigduo XR (dapagliflozin and metformin) Generic products containing sodium-glucose cotransporter-2 (SGLT-2) inhibitors Tubulointerstitial nephritis FDA determined that no action is necessary at the time based on available information. Somatostatin Receptor Imaging Agents Detectnet (copper Cu-64 dotatate injection) Gallium Dotatoc (GA 68) Octreoscan (Indium In 111 Pentetreotide) Netspot (Gallium GA 68 Dotatate) Hypersensitivity The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include hypersensitivity reactions. Example: Netspot labeling Stromectol (ivermectin) Generic products containing ivermectin Off label use FDA determined that no action is necessary at the time based on available information. Stromectol (ivermectin) Generic products containing ivermectin Neurotoxicity The "Warnings", "Adverse Reactions", and "Overdosage" sections of the labeling were updated in March 2022 to include neurotoxicity. Example: Stromectol labeling Sunosi (solriamfetol hydrochloride) Hypersensitivity FDA determined that no action is necessary at the time based on available information. Vivitrol (naltrexone) Incorrect route of product administration The container label (vial), carton labeling, "Dosage and Administration", "Warnings and Precautions", and "Description", sections of the labeling were revised in September 2022 to emphasize the appropriate route and site of administration. Vivitrol labeling Xcopri (cenobamate) Psychiatric disorders The "Adverse Reactions" section of the labeling was updated in June 2022 to include psychiatric disorders. Xcopri labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug Approval

04 Aug 2025

·pharma.economictimes.indiatimes.com

NPPA sets retail prices of 37 drugs; notifies 4 scheduled formulations ceiling price

New Delhi: India’s drug price controller, NPPA has fixed the retail prices of 37 new drug including key type-2 diabetes formulations, antibiotics, cardiac therapies among several others. Issuing a gazette notification, the National Pharmaceutical Pricing Authority (NPPA) announced that the based on the decision of the 135th Authority meeting, the body has fixed retail prices of 37 formulations under Drugs (Prices Control) Order, 2013.” The notified list of 37 formulations includes key diabetes formulations of Empagliflozin, Sitagliptin, Meformin and Linagliptin. Additionally the list comprises formulation of Atorvastatin & Ezetimibe indicated for the treatment of high cholesterol and fats. The list further lunches other common anti-inflammatory formulations and drugs like Paracetamol, Diclofenac among several others. Under the Drugs Price Control Order any marketer, or manufacturers that intends to market a new drug in India is required to obtain a prior approval of the particular drug retail price from the NPPA and in case the fixed price is not complied, then the concerned manufacturer/marketing company is required to deposit the overcharged amount along with an interests per the relevant provision. However, the fixed retail prices are applicable only to the individual manufacturer / marketer who have applied for the same and are specified in the mentioned in the notified list. Meanwhile, in a separate gazette notification the national drug price controller has fixed the ceiling price of four scheduled formulations. The latest notified list includes Ipratropium, Sodium nitroprusside, Povidone iodine, and Diltiazem. Ipratropium is a ‘respirator solution’ indicated for the treatment of condictions like COPD and the drug ceiling price is capped at ₹2.96 per unit. Sodium nitroprusside is an injectable used to control high blood pressure and ceiling price of the formulation is fixed at ₹28.99. The other two scheduled formulations Povidone iodine and Diltiazem are used to treat skin infections and angina (severe chest pain), and the their ceiling price is fixed at ₹6.26 per ml and ₹26.72 per capsule respectively. According to the Ministry of Health and Family Welfare , the National list of Essential Medicines includes those formulations which are indicated for the treatment of diseases which is a public health problem in India, recommended under National Health Programs of India and several other factors. The prices of drugs categorised in the list are fixed and maintained by the NPPA to ensure the affordability of essential drugs for consumers and currently the list includes over 900 formulations. By Online Bureau ,

NDA

04 Aug 2025

·pharma.economictimes.indiatimes.com

NPPA sets retail prices of 37 drugs; notifies 4 scheduled formulations ceiling price

NDA

100 Deals associated with Linagliptin

External Link

KEGG	Wiki	ATC	Drug Bank
D09566	Linagliptin	A10BH05	DB08882

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	United States	Boehringer Ingelheim Pharmaceuticals, Inc.	02 May 2011

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Stiffness	Phase 3	Netherlands	Boehringer Ingelheim GmbH	01 Mar 2014
Albuminuria	Phase 3	United States	Boehringer Ingelheim GmbH	01 Feb 2013
Albuminuria	Phase 3	United States	Eli Lilly & Co.	01 Feb 2013
Albuminuria	Phase 3	Japan	Eli Lilly & Co.	01 Feb 2013
Albuminuria	Phase 3	Japan	Boehringer Ingelheim GmbH	01 Feb 2013
Albuminuria	Phase 3	Canada	Boehringer Ingelheim GmbH	01 Feb 2013
Albuminuria	Phase 3	Canada	Eli Lilly & Co.	01 Feb 2013
Albuminuria	Phase 3	Denmark	Eli Lilly & Co.	01 Feb 2013
Albuminuria	Phase 3	Denmark	Boehringer Ingelheim GmbH	01 Feb 2013
Albuminuria	Phase 3	Finland	Boehringer Ingelheim GmbH	01 Feb 2013

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03194945 (Literature) Manual	Phase 4	Diabetes Mellitus, Type 2	412	Linagliptin plus Metformin	kwofaqdbwk(westswaiiu) = ldswowrwxw cgehdqahmb (hyrqhbufdp ) View more	Positive	15 Oct 2024
				Linagliptin	kwofaqdbwk(westswaiiu) = xfkpzsixuh cgehdqahmb (hyrqhbufdp ) View more
NCT03470454 (Pubmed \| Ren Fail)	Not Applicable	Acute Kidney Injury	800	N-acetyl cysteine and saline	mdamjxpcyc(oxoxagfkfz) = pcgbqimykp wnqnjlotro (nlxdhffgix )	-	31 Dec 2023
				Allopurinol	mdamjxpcyc(oxoxagfkfz) = zqhvgcmlzb wnqnjlotro (nlxdhffgix )
NCT04564872 (HSK7653, EASD2023)	Phase 3	Diabetes Mellitus, Type 2 Add-on	-	HSK7653 10mg	gxdgjcaptw(tprmyvrptb) = zwbttauakt hdiwzokoyq (nyubytbfti, -1.08 to -0.83)	Positive	03 Oct 2023
				HSK7653 25mg	gxdgjcaptw(tprmyvrptb) = yokswcpxzt hdiwzokoyq (nyubytbfti, -1.12 to -0.87)
NCT02372630 (1971, CTgov)	Phase 4	Insulin Resistance \| Inflammation \| Type 2 diabetes mellitus in obese ... View more	40	Placebo (Placebo)	vnnvrixrnf(hffuquxwvk) = oaukbxjbww tacplrvpjh (gvrtgfozoz, 0.148) View more	-	21 Feb 2023
				Linagliptin (Linagliptin 5mg Per Day)	vnnvrixrnf(hffuquxwvk) = lcrnnqrmis tacplrvpjh (gvrtgfozoz, 0.129) View more
NCT02467478 (CTgov)	Phase 4	Diabetes Mellitus, Type 2 \| Renal Insufficiency \| Chronic Kidney Diseases	31	Placebo (Placebo)	dlxytwsxsh(atowvfabor) = tgdkzsmoiz bupzoeuiah (vzdavvykis, 1.11) View more	-	19 Jan 2023
				Linagliptin (Linagliptin)	dlxytwsxsh(atowvfabor) = gchseunvmr bupzoeuiah (vzdavvykis, 2.80) View more
NCT01650259 (Pubmed \| Expert Opin Drug Saf)	Not Applicable	Diabetes Mellitus, Type 2	4,876	linagliptin (BMI <25 kg/m2)	bakxwaqpsh(gbbymwivew) = haprmrzrom yvhgegmwai (avgoqykdax ) View more	-	14 Apr 2022
				linagliptin (BMI 25 to <30 kg/m2)	bakxwaqpsh(gbbymwivew) = numdxbbtpc yvhgegmwai (avgoqykdax ) View more
NCT04542213 (Pubmed \| Sci Rep)	Phase 3	COVID-19	73	Linagliptin + insulin	ijchhnbjzq(nkqfdtudws) = No major side effects were observed cvznpecxvh (pfqypebllh )	Positive	11 Jan 2022
				Insulin alone
NCT04371978 (Pubmed \| Front Endocrinol (Lausanne)) Manual	Phase 3	COVID-19 \| Diabetes Mellitus	64	standard therapy+Linagliptin	uhxjxjfjyc(jfjqokxhdq) = kbrhuplync tekvjklhuz (aitspsseqf, 3.5 - 15) View more	Similar	22 Dec 2021
				standard therapy	uhxjxjfjyc(jfjqokxhdq) = hbbsmntrbl tekvjklhuz (aitspsseqf, 3.5 - 28) View more
NCT02851745 (DYDA 2, Pubmed 1 \| Pubmed 2 \| Eur J Prev Cardiol)	Phase 3	Diabetes Mellitus, Type 2	188	Linagliptin 5mg	crbhgaqlgt(dmwilfvqfw) = onphijhloi shqqpzcshb (lgcxwiperz )	-	23 Mar 2021
				Placebo	crbhgaqlgt(dmwilfvqfw) = dgolctqnma shqqpzcshb (lgcxwiperz )
NCT02897349 (Pubmed \| Diabetes Obes Metab) Manual	Phase 3	Diabetes Mellitus, Type 2	206	linagliptin	znkydxahvj(vfsfrizfwu) = qtkhojpkhq tsibrksffq (anlagxsnmr ) View more	Positive	01 Feb 2021
				Placebo	znkydxahvj(vfsfrizfwu) = fzhesmcgfc tsibrksffq (anlagxsnmr ) View more

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