A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Trial and Open-Label Extension Study to Evaluate the Efficacy and Safety of Add-On Therapy With Empagliflozin for Patients With Inadequately Controlled Type 2 DiabetesMellitus in the Combination Treatment With Metformin and Alogliptin

Phase 3 study to assess the Efficacy and Safety of CT-L02-301 in Type 2 Diabetes Patients with Insufficient Glycemic Control with Metformin and Alogliptin Combination Therapy.

Start Date18 Jul 2025

Sponsor / Collaborator

Celltrion, Inc.

CTR20250730

/ CompletedNot Applicable

苯甲酸阿格列汀片（25mg）在中国健康受试者中空腹给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of alogliptin benzoate tablets (25 mg) in Chinese healthy subjects under fasting conditions

主要研究目的：按有关生物等效性试验的规定，选择Takeda Pharmaceutical Company Limited为持证商的苯甲酸阿格列汀片（商品名：尼欣那，规格：25mg）为参比制剂，对石家庄四药有限公司生产并提供的受试制剂苯甲酸阿格列汀片（规格：25mg）进行空腹给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在空腹给药条件下的生物等效性。次要研究目的：观察健康受试者口服受试制剂苯甲酸阿格列汀片（规格：25mg）和参比制剂苯甲酸阿格列汀片（商品名：尼欣那，规格：25mg）的安全性。

[Translation]

Main purpose of study: According to the relevant provisions of bioequivalence test, Takeda Pharmaceutical Company Limited was selected as the reference preparation for alogliptin benzoate tablets (trade name: Nisina, specification: 25mg), and the test preparation alogliptin benzoate tablets (specification: 25mg) produced and provided by Shijiazhuang Siyao Co., Ltd. was used for fasting human bioequivalence test, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting conditions. Secondary purpose of study: To observe the safety of oral administration of the test preparation alogliptin benzoate tablets (specification: 25mg) and the reference preparation alogliptin benzoate tablets (trade name: Nisina, specification: 25mg) in healthy subjects.

Start Date24 Mar 2025

Sponsor / Collaborator

Shijiazhuang No. 4 Pharmaceutical Co., Ltd.

CTR20250729

/ CompletedNot Applicable

苯甲酸阿格列汀片（25mg）在中国健康受试者中餐后给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验

主要研究目的：按有关生物等效性试验的规定，选择Takeda Pharmaceutical Company Limited为持证商的苯甲酸阿格列汀片（商品名：尼欣那，规格：25mg）为参比制剂，对石家庄四药有限公司生产并提供的受试制剂苯甲酸阿格列汀片（规格：25mg）进行餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在餐后给药条件下的生物等效性。次要研究目的：观察健康受试者口服受试制剂苯甲酸阿格列汀片（规格：25mg）和参比制剂苯甲酸阿格列汀片（商品名：尼欣那，规格：25mg）的安全性。

[Translation]

Main purpose of study: According to the relevant provisions of bioequivalence test, Takeda Pharmaceutical Company Limited was selected as the reference preparation for alogliptin benzoate tablets (trade name: Nisina, specification: 25mg), and the test preparation alogliptin benzoate tablets (specification: 25mg) produced and provided by Shijiazhuang Siyao Co., Ltd. was used for human bioequivalence test after meal administration. The difference between the absorption rate and absorption extent of the drug in the test preparation and the reference preparation was compared to see whether it was within an acceptable range, and to evaluate the bioequivalence of the two preparations under the condition of postprandial administration. Secondary purpose of study: To observe the safety of oral administration of the test preparation alogliptin benzoate tablets (specification: 25mg) and the reference preparation alogliptin benzoate tablets (trade name: Nisina, specification: 25mg) to healthy subjects.

Start Date23 Mar 2025

Sponsor / Collaborator

Shijiazhuang No. 4 Pharmaceutical Co., Ltd.

100 Clinical Results associated with Alogliptin Benzoate

100 Translational Medicine associated with Alogliptin Benzoate

100 Patents (Medical) associated with Alogliptin Benzoate

866

Literatures (Medical) associated with Alogliptin Benzoate

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 Sep 2025·Cureus Journal of Medical Science

Efficacy and Safety of Vildagliptin Versus Other Dipeptidyl Peptidase 4 (DPP-4) Inhibitors in the Management of Type 2 Diabetes Mellitus: A Systematic Review of Randomized Controlled Trials

Review

Author: Selvaraj, Vinodhini

Dipeptidyl peptidase 4 inhibitors (DPP-4 inhibitors) are used as second-line drugs in the treatment of type 2 diabetes mellitus (T2DM) patients. They act by preventing the breakdown of incretin hormones, which enhance insulin secretion and reduce glucagon secretion. Vildagliptin and sitagliptin are more commonly used DPP-4 inhibitors. In recent years, the use of DPP-4 inhibitors has been increasing; hence, it is important to evaluate the comparative efficacy and safety of this medication with available evidence. Moreover, this systematic review will evaluate to look for any specific superiority or safety advantage of using Vildagliptin over other DPP-4 inhibitors. In accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we conducted a systematic review search with Cochrane and PubMed databases. Two independent reviewers examined randomized controlled trial (RCT) studies against the inclusion criteria. Excluded studies involve type 1 diabetes, gestational diabetes, and severe acute diabetic complications. Finally, five RCT studies were chosen, involving 296 participants overall. Baseline and outcome values with p-values and intergroup differences with their p-value from original studies were gathered to evaluate the significance of using vildagliptin over DPP-4 inhibitors, and findings were provided in a narrative way with available evidence. All five RCT studies have demonstrated a significant reduction in HbA1c from baseline, ranging from -0.3 to -1.34 with p-value <0.05 in the vildagliptin group and -0.1 to -1.07 with p-value >0.05 in other DPP-4 inhibitors, with no significant intergroup differences indicating comparable efficacy between vildagliptin and other DPP-4 inhibitors. Similarly, no significant intergroup differences were observed between vildagliptin and comparator agents in reducing fasting plasma glucose and postprandial glucose. Notably, one study reported a significant reduction favoring vildagliptin, while another showed a greater reduction of FPG with alogliptin; however, intergroup comparisons were not statistically significant. In addition, vildagliptin did not show consistent improvement in lipid profile across the involved studies. Vildagliptin showed a low incidence of hypoglycemic events in comparison with other DPP-4 inhibitors. Overall, this systematic review found no significant superiority of vildagliptin over other DPP-4 inhibitors such as sitagliptin and alogliptin in the management of type 2 diabetes mellitus, whether used as monotherapy or in combination therapy.

09 Jul 2025·Current Reviews in Clinical and Experimental Pharmacology

Dipeptidyl Peptidase-4 Inhibitors and the Risk of Fractures in Type 2 Diabetes Mellitus Patients: A Bayesian Network Meta-Analysis

Article

Author: Azharuddin, Mohammad ; Vohora, Divya ; Adil, Mohammad ; Sharma, Manju ; Ansari, Shamsuzzaman ; Ahmad, Tufail

Background/Objective::

Type 2 diabetes mellitus (T2DM) increases the risk of fractures and its effects on bone health. The impact of dipeptidyl peptidase-4 inhibitors (DPP-4i) on bone fracture risk is unclear. We performed a network meta-analysis (NMA) to assess the impact of DPP-4i on fracture risk in patients with T2DM.

Methods::

A comprehensive systematic literature search was conducted on PubMed/Medline, Cochrane Library, and ClinicalTrials.gov until June 2024 to identify RCTs reporting fracture events with DPP-4i among T2DM patients. A Bayesian NMA has been performed to calculate the odds ratio (OR) and 95% credible intervals (CrI). Surface under the cumulative ranking analysis (SUCRA) was utilized to assess the rank probability of DPP-4i.

Results::

A total of 85 RCTs were identified, including 89,965 T2DM patients with 1,083 fracture events. In the direct meta-analysis, DPP-4i did not elevate fracture risk compared to placebo or other oral anti-diabetics (OADs) (OR (95%CI): 1.04 (0.91-1.18); p=0.57 and 1.18 (0.79-1.74); p=0.96, respectively). Alogliptin and sitagliptin indicated a non-significant trend towards reducing fracture risk compared to placebo (OR (95%CI): 0.59 (0.31-1.15); p=0.12) and OADs (OR (95%CI): 0.73 (0.41-1.30); p=0.28), respectively. In the NMA, alogliptin significantly reduced fracture risk compared to linagliptin and SGLT2i (OR (95%CrI): 0.41 (0.16-0.93) and 0.16 (0.017-0.83), respectively). Conversely, linagliptin increased fracture risk compared to sulfonylurea (OR (95%CrI): 2.3 (1.1-5.2)). According to SUCRA, alogliptin (84%) ranked as the preferred treatment for reducing fracture risk in T2DM patients.

Conclusion::

Overall, DPP-4i was not associated with an increased risk of fractures in patients with T2DM. However, alogliptin demonstrated a reduced risk of fractures when compared to both linagliptin and SGLT2i. Further long-term clinical studies are needed to confirm the present findings.

News (Medical) associated with Alogliptin Benzoate

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

23 May 2025

·pharma.economictimes.indiatimes.com

GLP-1 diabetes drugs like Ozempic may modestly reduce cancer risks

London: Widely used GLP-1 drugs for type 2 diabetes such as Novo Nordisk 's Ozempic may modestly reduce the risk of obesity-related cancers, especially colorectal cancer , according to data released on Thursday ahead of a major medical meeting. Among more than 85,000 people with type 2 diabetes and obesity treated between 2013 and 2023 and followed for an average of nearly four years, 2,501 obesity-related cancers developed in those taking GLP-1 diabetes drugs , compared with 2,671 such cancers in those treating their diabetes with drugs from a class known as DPP-4 inhibitors . After accounting for individual risk factors, those taking GLP-1 drugs had a 7 per cent lower risk of developing an obesity-related cancer and an 8 per cent lower risk of death from any cause compared to those who took a DPP-4 inhibitor, a brief summary of data to be presented at the upcoming American Society of Clinical Oncology meeting in Chicago showed. The effect was only statistically significant in women, researchers said. Other GLP-1 drugs for improving blood glucose control taken by patients in the study include Eli Lilly's Trulicity and Novo's Victoza and Rybelsus, among others. These drugs deliver a lower dose of their main ingredient compared to GLP-1 drugs designed to induce weight loss. DPP-4 inhibitors include Merck & Co's Januvia and Nesina from Takeda Pharmaceuticals. While a modestly reduced risk for 14 obesity-related cancers was evident with GLP-1 drugs, the suggestion of a protective effect was particularly strong for colorectal malignancies. There were 16 per cent fewer colon cancer cases and 28 per cent fewer rectal cancer cases in the group prescribed GLP-1 receptor agonists. Observational studies like this cannot prove that the GLP-1 drugs caused lower cancer rates. "These data are reassuring, but more studies are required to prove causation," lead study author Lucas Mavromatis, a medical student at the NYU Grossman School of Medicine in New York, said in a statement. (Reporting by Nancy Lapid; Editing by Bill Berkrot)

ASCOClinical Result

23 May 2025

·pharma.economictimes.indiatimes.com

GLP-1 diabetes drugs like Ozempic may modestly reduce cancer risks

ASCOClinical Result

100 Deals associated with Alogliptin Benzoate

External Link

KEGG	Wiki	ATC	Drug Bank
D06553	Alogliptin Benzoate	A10BH04	DB06203

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Japan	Teijin Pharma Ltd.	06 Apr 2010
Diabetes Mellitus, Type 2	Japan	Takeda Pharmaceutical Co., Ltd.	06 Apr 2010

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Acute Coronary Syndrome	Phase 3	United States	Takeda Pharmaceutical Co., Ltd.	01 Sep 2009
Acute Coronary Syndrome	Phase 3	Japan	Takeda Pharmaceutical Co., Ltd.	01 Sep 2009
Acute Coronary Syndrome	Phase 3	Argentina	Takeda Pharmaceutical Co., Ltd.	01 Sep 2009
Acute Coronary Syndrome	Phase 3	Australia	Takeda Pharmaceutical Co., Ltd.	01 Sep 2009
Acute Coronary Syndrome	Phase 3	Austria	Takeda Pharmaceutical Co., Ltd.	01 Sep 2009
Acute Coronary Syndrome	Phase 3	Belgium	Takeda Pharmaceutical Co., Ltd.	01 Sep 2009
Acute Coronary Syndrome	Phase 3	Brazil	Takeda Pharmaceutical Co., Ltd.	01 Sep 2009
Acute Coronary Syndrome	Phase 3	Bulgaria	Takeda Pharmaceutical Co., Ltd.	01 Sep 2009
Acute Coronary Syndrome	Phase 3	Canada	Takeda Pharmaceutical Co., Ltd.	01 Sep 2009
Acute Coronary Syndrome	Phase 3	Chile	Takeda Pharmaceutical Co., Ltd.	01 Sep 2009

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02856113 (2015-000208-25, Pubmed \| Diabetes Ther)	Phase 3	Diabetes Mellitus, Type 2	152	Alogliptin 25 mg QD	acrpvkdmpb(wcvsidlsvn) = kbhzhanqps irhmjyqgtp (vnucnqnibo, -0.63 to 0.83)	Negative	04 Mar 2025
1340-P (ADA2024)	Not Applicable	Diabetes Mellitus	-	SGLT2i	pdukmvhqws(pqyfcyhgxf) = ecesqzmpst pepinzmaqn (qbprsjnpye, 16.6 - 19.7)	Positive	14 Jun 2024
				DPP4i	pdukmvhqws(pqyfcyhgxf) = bvixrsqefn pepinzmaqn (qbprsjnpye, 19.1 - 21.4)
NCT05782192 (Pubmed)	Phase 3	Diabetes Mellitus, Type 2	-	Fotagliptin	tfwdhzhyfv(qjggzxozcj) = vxoabcoftv vqhqkyudgo (iqxjsyvauv ) View more	Positive	09 Oct 2023
				Alogliptin	tfwdhzhyfv(qjggzxozcj) = fhrltecubm vqhqkyudgo (iqxjsyvauv ) View more
NCT02856113 (2015-000208-25, CTgov)	Phase 3	Diabetes Mellitus, Type 2	152	Placebo (Placebo)	vphxbdykoq(lftjrpbnme) = pjujuixiwc imyrcodlkn (dghamfisbc, 0.2809) View more	-	19 Oct 2022
				Alogliptin Benzoate (Alogliptin 25 mg)	vphxbdykoq(lftjrpbnme) = qasajkxqtc imyrcodlkn (dghamfisbc, 0.2879) View more
NCT03794336 (ACADEMIC, Pubmed \| Diabetes Obes Metab) Manual	Phase 4	Diabetes Mellitus, Type 2 \| Coronary Disease	1,088	aspirin+alogliptin	rcoqfwgdpj(orbmaniqhx) = oagjohyrvl eymcvegrfq (czqrjpixgj, 0.4) View more	Positive	03 Feb 2022
				aspirin+acarbose	rcoqfwgdpj(orbmaniqhx) = zjwbiigjfv eymcvegrfq (czqrjpixgj, 0.5) View more
NCT03794336 (EASD2021)	Phase 4	Cardiovascular Diseases \| Diabetes Mellitus, Type 2 \| Coronary Disease	-	Alogliptin 25 mg q.d.	rbpdyqhfdt(qtwrbdqtqa) = Significantly lesser GI adverse events were observed with alogliptin than acarbose (8.9% vs 33.6%, P <0.0001) oscebwcyih (yqprvgehfz ) View more	Positive	29 Sep 2021
				Acarbose 100 mg t.i.d.
NCT03231709 (TRINITY, Pubmed \| Curr Med Res Opin)	Phase 4	Diabetes Mellitus, Type 2	-	Trelagliptin	znomealbpa(malmngygeo) = fboyxehmgt fkinrubghf (dcjofhpuzn )	-	02 Dec 2019
				Alogliptin	znomealbpa(malmngygeo) = uqsdfjawpj fkinrubghf (dcjofhpuzn )
NCT03501277 (CTgov)	Phase 1	-	72	alogliptin+pioglitazone+SYR-322-4833 BL (Regimen A)	ixreikyezv(sofhnhbkou) = mipsnhiruk glrdwvhohs (tjzuoxslko, 42.87) View more	-	08 Aug 2019
				Alogliptin+pioglitazone (Regimen B)	ixreikyezv(sofhnhbkou) = nezgnmayrc glrdwvhohs (tjzuoxslko, 44.71) View more
NCT03231709 (TRINITY, CTgov)	Phase 4	Diabetes Mellitus, Type 2	60	Trelagliptin+Alogliptin (Trelagliptin 100 mg + Alogliptin 25 mg)	ntgteoiepo = aslebkyauq omjnvxdkjv (pkhoqsoqre, esviuqnqkn - dnpehamqxy) View more	-	10 May 2019
				Trelagliptin+Alogliptin (Alogliptin 25 mg + Trelagliptin 100 mg)	ntgteoiepo = goxrhhkbfd omjnvxdkjv (pkhoqsoqre, owbrsruqzy - vbojguimet) View more
NCT02771093 (TRACK, CTgov)	Phase 4	Diabetes Mellitus, Type 2	27	Trelagliptin (Trelagliptin 100 mg)	aginlpvtif(taigmiawil) = drzsjgdvnf vfvvfdzppv (velkbinmak, canyssbpwa - yxbuifibfs) View more	-	10 Dec 2018
				Alogliptin (Alogliptin 25 mg)	aginlpvtif(taigmiawil) = sewguhlmit vfvvfdzppv (velkbinmak, mvxrmqmozm - etucfuqanz) View more

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