Single-blinded, Double-arm, Controlled, Randomized, Multicentre Clinical Trial to Evaluate the Impact of Pharmacogenetic-guided Treatment in Patients With Insufficiently Controlled Type 2 Diabetes

The goal of this clinical trial is to assess the efficacy of a pharmacogenetics-guided treatment, compared to standard optimized treatment, in patients with inadequately controlled type 2 diabetes. The main questions it aims to answer are:
* Is the disease better controlled when the treatment prescribed is based on the participant's pharmacogenetic profile?
* What medical problems do participants experience while taking the treatment?
Participants will:
* Take the treatment described according to the Summary of Product Characteristics (SmPC).
* Visit the clinic once every 12 weeks for checkups and tests.
* Keep a diary of their symptoms to inform the Investigator.

Start Date01 Apr 2025

Sponsor / Collaborator-

TCTR20240817009

/ Not yet recruitingPhase 1

A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Fixed-dose Combination of Vildagliptin and Metformin 50/1000 mg Film-coated Tablets and Reference Product (GALVUS MET (50 MG/1000 MG)) in Healthy Thai Volunteers under Fed Conditions

Start Date06 Feb 2025

Sponsor / Collaborator-

TCTR20240908005

/ Not yet recruitingPhase 1

A Bioequivalence Study of Two Formulations of Fixed Dose Combination Tablets of Vildagliptin 50 mg and Metformin Hydrochloride 1000 mg in Healthy Thai Subjects under Fed Conditions

Start Date08 Dec 2024

Sponsor / Collaborator

SciGen Pte Ltd.

100 Clinical Results associated with Vildagliptin

100 Translational Medicine associated with Vildagliptin

100 Patents (Medical) associated with Vildagliptin

2,241

Literatures (Medical) associated with Vildagliptin

01 Apr 2025·NAUNYN-SCHMIEDEBERGS ARCHIVES OF PHARMACOLOGY

Vitamin D3 mitigates myopathy and metabolic dysfunction in rats with metabolic syndrome: the potential role of dipeptidyl peptidase-4

Article

Author: Ghareib, Salah A ; Shoier, Nourhan O ; El-Sayed, Shaimaa S ; Kothayer, Hend ; Alsemeh, Amira Ebrahim

Abstract :

Metabolic syndrome is associated with vitamin D3 deficiency. This work aims to examine the efficacy of vitamin D3 in inhibiting MetS-induced myopathy and to determine whether the beneficial effects of vitamin D3 are mediated by the inhibition of dipeptidyl peptidase-4 (DPP-4). An in silico study investigated the potential effectiveness of vitamin D3 on the inhibition of the DPP-4 enzyme. An in vitro assay of the DPP-4 inhibitory effect of vitamin D3 was performed. In vivo and over 12 weeks, both diet (with 3% salt) and drinking water (with 10% fructose) were utilized to induce MetS. In the seventh week, rats received either vitamin D3, vildagliptin, a combination of both, or vehicles. Serum lipids, adipokines, glycemic indices, and glucagon-like peptide-1 (GLP-1), muscular glucose transporter type-4 (GLUT-4) content, DPP-4, adenosine monophosphate kinase (AMPK) activities, and Sudan Black B-stained lipids were assessed. Muscular reactive oxygen species (ROS), caspase-3, and desmin immunostaining were used to determine myopathy. MetS-induced metabolic dysfunction was ameliorated by vitamin D3, which also reduced intramuscular glycogen and lipid accumulation. This is demonstrated by the attenuation of MetS-induced myopathy by vitamin D3, decreased oxidative stress, increased desmin immuno-expression, and caspase-3 activity. Our in silico data demonstrated that vitamin D3 is capable of inhibiting DPP-4, which is further supported by biochemical findings. Vitamin D3 increased serum GLP-1, muscular AMPK activity, and GLUT-4 content, whereas the levels of muscular ROS were decreased in MetS. Vildagliptin and its combination with vitamin D3 yielded comparable results. It is suggested that the DPP-4 inhibitory potential of vitamin D3 is responsible for the amelioration of MetS-induced metabolic changes and myopathy.

16 Mar 2025·POSTGRADUATE MEDICAL JOURNAL

Effects of new hypoglycemic drugs on patients with heart failure: a systematic review and network meta-analysis

Review

Author: Chen, Jun ; Gao, Hongmei ; Song, Ruirui ; Liu, Fang ; Sun, Songtao ; Shi, Xiaojing

Abstract:

Background:

Currently, there is no relevant study comparing sodium-dependent glucose transporter 2 inhibitors (SGLT2i), glucagon-like peptide-1 receptor agonists (GLP-1RA), and dipeptidyl peptidase inhibitor (DPP4i) head to head to evaluate their comprehensive impact on heart failure patients.

Methods:

We conducted a comprehensive literature search across multiple databases. Utilizing the risk of bias tool from the Cochrane Collaboration, the methodological quality of included studies was critically assessed and potential publication bias was examined via funnel plots.

Results:

All results are presented as mean difference; 95% confidence interval (MD; 95% CI). The network meta-analysis indicated that in regards to left ventricular function, there is a big difference in the left ventricular ejection fraction (LVEF) of Empagliflozin 25 mg (13.64; 0.26, 27.01) compared to Canagliflozin 100 mg; and significant differences in the left ventricular end-diastolic volume (LVEDV) and left ventricular end-systolic volume (LVESV) of Dapagliflozin 10 mg (−0.76; −1.27, −0.25 and −0.95; −1.86, −0.05), Vildagliptin 50 mg (−1.05; −1.47, −0.63 and −1.12; −2.19, −0.05), and Sitagliptin 100 mg (−1.34; −2.31, −0.38 and −1.89; −3.50, −0.27) compared to Empagliflozin 10 mg. In terms of the quality of life, there are significant differences in the N-terminal pro-B-type natriuretic peptide (NT-proBNP) and the Quality of life score of Sitagliptin 100 mg (408.08; 213.59, 602.57 and 3.74; 1.57, 5.92) compared to Dapagliflozin 5 mg. In terms of the cardiovascular outcome events, there is a significant difference in the heart failure rehospitalization rate of Dapagliflozin 10 mg (0.45; 0.25, 0.82) and Empagliflozin 10 mg (0.48; 0.28, 0.81) compared to Liraglutide 1.8 mg. Further significant differences are found in the all-cause mortality of Dapagliflozin 10 mg (0.81; 0.66, 0.98) compared to Vildagliptin 50 mg; the cardiovascular death of Albiglutide 30 mg (0.49; 0.28, 0.86) compared to Exenatide 2 mg; and the arrhythmic events of Liraglutide 1.8 mg (0.49; 0.26, 0.90) compared to Empagliflozin 10 mg. The network meta-analysis of SGLT2i, GLP-1RA, and DPP4i as a class of drugs showed that GLP-1RA is superior to SGLT2i in improving LVEF and reducing myocardial infarction/acute coronary syndrome, whereas DPP4i is superior to SGLT2i in improving LVEDV and LVESV.

Conclusions:

GLP-1RA is superior to SGLT2i in improving LVEF and reducing myocardial infarction/acute coronary syndrome, whereas DPP4i is superior to SGLT2i in improving LVEDV and LVESV.Key message What is already known on this topic—It has been confirmed that three new hypoglycemic drugs have a protective effect on the cardiovascular system. Studies have shown that sodium-dependent glucose transporter 2 inhibitors (SGLT2i) can improve cardiovascular outcomes and enhance the quality of life of heart failure patients. Currently, SGLT2i is widely used in the clinical treatment of heart failure, and related studies have shown that glucagon-like peptide-1 receptor agonists (GLP-1RA) and dipeptidyl peptidase inhibitor (DPP4i) also play important roles in the treatment of heart failure. What this study adds—However, there is no relevant research on whether these drugs’ clinical efficacy is dose-dependent. How this study might affect research, practice, or policy—This study included different doses of hypoglycemic drugs and used a network meta-analysis method to comprehensively evaluate the effects of three hypoglycemic drugs on heart function, quality of life, and prognosis in heart failure patients, providing a basis for clinical practice.

01 Mar 2025·Drugs-Real World Outcomes

Effectiveness and Safety of Vildagliptin Sustained Release in the Management of Type 2 Diabetes Mellitus: Real-World Evidence in Indian Patients [NOVELTY Study]

Article

Author: Iyer, Rahul ; Sharma, Surendra Kumar ; Gogtay, Jaideep ; Sugumaran, Amarnath ; Bhansali, Anil ; Sahay, Rakesh ; Mohanasundaram, Senthilnathan

BACKGROUND AND OBJECTIVE:

Vildagliptin sustained release (XR), a formulation that provides vildagliptin 100 mg with a once-daily dose administration, is a recent introduction to manage type 2 diabetes mellitus in India. This study aimed to evaluate the effectiveness and tolerability of vildagliptin XR in patients with type 2 diabetes in real-world clinical settings.

METHODS:

This was an observational, prospective, multicenter, cohort study conducted in India, which included patients with type 2 diabetes uncontrolled on metformin XR monotherapy with glycated hemoglobin (HbA1c) > 7.00%. Vildagliptin XR was added to their ongoing treatment. The primary endpoint was a change in HbA1c from baseline to 3 months. Secondary endpoints were changes in fasting plasma glucose, postprandial plasma glucose, percentage of patients achieving HbA1c < 7.00% at 3 months, and assessment of efficacy, tolerability, and safety.

RESULTS:

A total of 1691 patients from 118 centers were enrolled in this study, having a mean (standard deviation) age of 53.10 (11) years and a mean (standard deviation) HbA1c of 8.44 (1.35) %. At the end of the study, vildagliptin XR significantly reduced the mean HbA1c by 1.02% points (95% confidence interval 0.93-1.12; p < 0.001) from baseline. The mean fasting plasma glucose and postprandial plasma glucose levels were significantly reduced by 28.44 mg/dL (95% confidence interval 26.64-30.25; p < 0.001) and 48.45 mg/dL (95% confidence interval 45.91-50.99; p < 0.001), respectively, with vildagliptin XR, at the end of study. During the study duration, 34.7% of patients achieved their glycemic target (HbA1c < 7.0%) and there were three reported adverse events (all mild in severity).

CONCLUSIONS:

Results demonstrated that vildagliptin XR (100 mg once daily) significantly improved HbA1c and other glycemic parameters in Indian patients with type 2 diabetes and was well tolerated.

CLINICAL TRIAL REGISTRATION:

The study was registered under the Clinical Trials Registry India (CTRI/2022/01/039112).

News (Medical) associated with Vildagliptin

24 Nov 2023

·synapse.patsnap.com

What are DPP-4 inhibitors and how do you quickly get the latest development progress?

Dipeptidyl peptidase-4 (DPP-4) is an enzyme found in the human body that plays a crucial role in regulating glucose metabolism. It is primarily expressed in the pancreas, intestines, and immune cells. DPP-4 is responsible for breaking down incretin hormones, such as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), which are released after a meal to stimulate insulin secretion and reduce blood sugar levels. By inhibiting DPP-4 activity, pharmaceutical drugs can prolong the action of these incretin hormones, leading to increased insulin release, improved glycemic control, and potential therapeutic benefits for individuals with type 2 diabetes. Several dozens of DPP-4 inhibitors have been introduced to the market, with sitagliptin, vildagliptin, saxagliptin, alogliptin, and linagliptin being available in domestic markets. DPP-4 inhibitors can be combined with multiple antidiabetic drugs to form fixed-dose combinations, among which, the combinations with metformin are most common. The currently available DPP-4 inhibitor-metformin fixed-dose combinations in the domestic market include sitagliptin/metformin tablets, vildagliptin/metformin tablets, saxagliptin/metformin extended-release tablets, linagliptin/metformin tablets. DPP-4 inhibitors can be used as monotherapy for type 2 diabetes and can also be combined with other antidiabetic drugs for the treatment of type 2 diabetes. The most commonly combined antidiabetic drugs with DPP-4 inhibitors are metformin, followed by sulfonylureas, thiazolidinediones, and insulin. They can also be used in combination with two other antidiabetic drugs, forming a triple therapy commonly including combinations of DPP-4 inhibitors + metformin + sulfonylureas, DPP-4 inhibitors + metformin + thiazolidinediones, and DPP-4 inhibitors + metformin + insulin. The analysis of the target DPP-4 in the pharmaceutical industry reveals a competitive landscape with several companies focusing on the development of DPP-4 inhibitors. Merck & Co., Inc., Takeda Pharmaceutical Co., Ltd., C.H. Boehringer Sohn AG & Co. KG, LG Chem Ltd., and AstraZeneca PLC are among the companies growing fastest under this target. The primary indication for the approved drugs is diabetes mellitus, type 2. Small molecule drugs are progressing most rapidly, indicating intense competition around the innovative drug. The United States, European Union, Japan, and China are the countries/locations developing fastest under this target, with China showing significant progress. Overall, the target DPP-4 presents opportunities for further research and development in the treatment of diabetes and related indications. Unlocking Blood Sugar Control: The Role of DPP-4 Inhibitors in Type 2 Diabetes ManagementDPP-4 inhibitors, also known as dipeptidyl peptidase-4 inhibitors, are a type of medication used in the treatment of type 2 diabetes. From a biomedical perspective, DPP-4 inhibitors work by inhibiting the enzyme dipeptidyl peptidase-4 (DPP-4), which is responsible for breaking down incretin hormones in the body. Incretin hormones play a role in regulating blood sugar levels by stimulating the release of insulin and reducing the production of glucagon. By inhibiting DPP-4, these medications increase the levels of incretin hormones, leading to improved blood sugar control. DPP-4 inhibitors are typically taken orally and are often prescribed as an adjunct to diet and exercise in the management of type 2 diabetes. They can be used as monotherapy or in combination with other antidiabetic medications, such as metformin. Some common examples of DPP-4 inhibitors include sitagliptin, saxagliptin, linagliptin, and alogliptin. These medications have been shown to be effective in lowering blood sugar levels and have a favorable safety profile. It's important to note that DPP-4 inhibitors are not recommended for the treatment of type 1 diabetes or diabetic ketoacidosis. They are primarily used in the management of type 2 diabetes and can help improve glycemic control in individuals with this condition. As with any medication, DPP-4 inhibitors may have potential side effects, and it is essential to consult with a healthcare professional for proper evaluation and monitoring while taking these medications. Catalog of DPP-4 InhibitorsThe currently marketed DPP-4 inhibitors include: Sitagliptin/Metformin HydrochlorideSitagliptinRetagliptin PhosphateGemigliptin/DapagliflozinMetformin Hydrochloride/Sitagliptin HydrochlorideEmpagliflozin/Linagliptin/Metformin HydrochlorideAnagliptin/Metformin HydrochlorideErtugliflozin/Sitagliptin PhosphateGosogliptinEvogliptinFor more information, please click on the image below. What is the purpose of using DPP-4 inhibitors?DPP-4 inhibitors can be used as a mono-drug treatment for type 2 diabetes, or in combination with other glucose-lowering drugs for the treatment of type 2 diabetes. For more information, please click on the image below to log in and search. How can you get the most recent advancements in DPP-4 inhibitors?In the Synapse database, you can keep abreast of the latest research and development advances of DPP-4 inhibitors anywhere and anytime, daily or weekly, through the "Set Alert" function. Click on the image below to embark on a brand new journey of drug discovery!

10 Apr 2023

·www.pharmaceutical-technology.com

India’s Cipla signs licence deal with Novartis for diabetes drug Galvus

Novartis and Cipla signed a perpetual licence agreement for the diabetes drug Galvus. Credit: Novartis AG. India-based pharmaceutical company Cipla has entered into a perpetual licence agreement with Swiss drugmaker Novartis Pharma for the diabetes drug Galvus and its combination brands. Under the deal, Cipla will be responsible for the manufacturing and marketing of Galvus and its combination brands from 1 January 2026. Galvus brand products are mainly used in the treatment of patients with type 2 diabetes. The deal is dependent on the fulfilment of certain conditions precedent, but Cipla will continue to produce and sell Galvus branded products during the interim. Galvus specialises in the dipeptidyl peptidase-4 (DPP4) space, specifically in the oral diabetic medication category. Developed for oral use, Galvus is indicated as supplemental to diet and exercise to regulate blood glucose in type 2 diabetes mellitus patients. It can be used as monotherapy or in initial combination with metformin when diet and exercise alone do not adequately control diabetes. Furthermore, Galvus can be used in combination with other medicinal products such as insulin when they are unable to offer sufficient glycaemic control. With reported sales of $32.7m (Rs2.68bn), Galvus is anticipated to boost Cipla’s portfolio in the diabetes care segment. The deal is also anticipated to further strengthen the company’s position in India as one of the prominent players in the diabetes category.

License out/in

09 Jul 2013

·www.biospace.com

Datamonitor Release: AMNOG May Cause Havoc in German Diabetes Market - Analyst Opinion

Get the latest biotech news where you want it. Sign up for the free GenePool newsletter today! July 09, 2013 -- Text Expert analyst opinion on the impact of AMNOG, Germany’s Pharmaceutical Market Reorganization Act, on future diabetic therapies and leading diabetes players including Bristol-Myers Squibb/AstraZeneca, Novartis, and Merck & Co. Bristol-Myers Squibb/AstraZeneca, Novartis, and Merck & Co could soon have to drop the prices of their dipeptidyl peptidase-IV (DPP-IV) inhibitors Onglyza (saxagliptin), Galvus (vildagliptin), and Januvia (sitagliptin) in Germany if health technology appraisal bodies there remain less than impressed. The products are undergoing the first retrospective review under Germany’s tough Pharmaceutical Market Reorganization Act (AMNOG; Arzneimittelmarktneuordungsgesetz) pricing and reimbursement system, and the Institute for Quality and Efficiency in Healthcare (IQWiG; Institut für Qualitat und Wirtschaftlichkeit im Gesundheitswesen) released its preliminary findings on 1 July 2013. Pricing in Germany matters not only because it is one of Europe’s biggest markets, but also because a number of other European countries reference prices there. Therefore, price cuts in Germany could eventually lead to reductions elsewhere and impact significantly on company revenues. Read on here... Datamonitor Healthcare Help employers find you! Check out all the jobs and post your resume.

100 Deals associated with Vildagliptin

External Link

KEGG	Wiki	ATC	Drug Bank
D07080	Vildagliptin	A10BH02	DB04876

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	European Union	Novartis Europharm Ltd.	25 Sep 2007
Diabetes Mellitus, Type 2	Iceland	Novartis Europharm Ltd.	25 Sep 2007
Diabetes Mellitus, Type 2	Liechtenstein	Novartis Europharm Ltd.	25 Sep 2007
Diabetes Mellitus, Type 2	Norway	Novartis Europharm Ltd.	25 Sep 2007

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 1	Phase 3	Brazil	Novartis AG	01 Mar 2014
Insulin Resistance	Phase 3	United Kingdom	Novartis Pharmaceuticals Corp.	01 May 2010
Microvascular Disease	Phase 3	United Kingdom	Novartis Pharmaceuticals Corp.	01 May 2010
Hypoglycemia	Phase 3	Switzerland	Novartis AG	01 Sep 2006
Hyperglycemia	Phase 3	Germany	Novartis AG	20 Feb 2006
Glucose Intolerance	Phase 3	United States	Novartis AG	01 Oct 2005
Prediabetic State	Phase 3	United States	Novartis AG	01 Apr 2005
Diabetes Mellitus, Noninsulin-Dependent, 2	Phase 3	United States	Novartis AG	01 Nov 2004
Diabetic Neuropathies	Phase 2	France	Novartis Pharmaceuticals Corp.	01 Oct 2010
Diabetes Mellitus	Phase 2	Russia	Novartis Pharmaceuticals Canada, Inc.	01 Dec 2008

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Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ADA2024	Not Applicable	Diabetes Mellitus, Type 2	-	Glimepiride 1mg/Vildagliptin 50mg/Metformin 500mg	egnlbvdktd(qcuwgyguyb) = Three mild hypoglycemic events were reported with the starting dose seozomjaiz (fyotozrxns )	-	14 Jun 2024
				Glimepiride 2mg/Vildagliptin 50mg/Metformin 1000mg
NCT05359432 (Pubmed) Manual	Phase 4	Diabetes Mellitus, Type 2	120	metformin+empagliflozin	dngndredbh(itamtyktzt) = lumpdbciyg dqdhxtpbpb (ooyhxvtrjw, 0.68)	Positive	17 Aug 2022
				metformin+vildagliptin	dngndredbh(itamtyktzt) = xjqjbwxmyg dqdhxtpbpb (ooyhxvtrjw, 1.57)
ACTRN12618001907235 (Pubmed \| Front Endocrinol (Lausanne))	Phase 4	Hypertriglyceridemia \| Obesity	346	Pioglitazone 30mg	nnntfpqgfu(gelpaloszc) = koezcoqqpi rjqweirgrl (vnxqnirtvq )	-	01 Jan 2022
NCT03693560 (Pubmed \| Diabetes Res Clin Pract)	Phase 4	Coronary Artery Disease \| Diabetes Mellitus	80	Vildagliptin 50 mg/day	tdzlmhrjkk(dalxsxtdla) = ibclxrvvru yiqfssngzx (athiszighl )	-	01 Dec 2020
				Glimepiride 4 mg/day	tdzlmhrjkk(dalxsxtdla) = lqokbacjfp yiqfssngzx (athiszighl )
NCT01528254 (VERIFY study, EASD2020)	Phase 4	Diabetes Mellitus, Type 2	2,001	Vildagliptin plus Metformin	hjciwteojs(kusqrpiczk): adjusted mean change = 19.23 (95% CI, 8.42 - 30.03)	Positive	24 Sep 2020
				Metformin
ACTRN12614001117606 (EASD2019)	Phase 4	Diabetes Mellitus, Type 2 GLP-1	15	Vildagliptin 50 mg	kyrlkveogy(qcejmcmtps) = tbxowpvnqg ztbecbdeag (rvddmljjna )	Positive	19 Sep 2019
				Placebo	kyrlkveogy(qcejmcmtps) = gnfbaenqby ztbecbdeag (rvddmljjna )
SAT-141 (ENDO2019)	Not Applicable	Diabetes Mellitus, Type 2 \| Hypertension glycemic variability \| endothelial function	-	Vildagliptin	qaaskgrocu(sdfwuxrwna) = qrvqjgfgvh nukuyrfjsf (yzyjfuzfim, 42.6) View more	Positive	30 Apr 2019
				Glibenclamide	qaaskgrocu(sdfwuxrwna) = wzenncrias nukuyrfjsf (yzyjfuzfim, 54) View more
NCT01703637 (Pubmed \| Endocr Connect)	Not Applicable	Diabetes Mellitus	300	Sitagliptin 100mg	orskimbaua(gohegjowfb) = elbnpcpxdm xjnngyeepz (vdlditqoeh, -0.20 to -0.90)	-	01 Apr 2019
				Vildagliptin 50mg	orskimbaua(gohegjowfb) = glwybasfml xjnngyeepz (vdlditqoeh, -0.40 to -1.40)
5704 (EASD2018)	Not Applicable	Diabetes Mellitus, Type 2	65	Insulin + Vildagliptin	exjyhdjnen(ltetevaigh) = pzmkgpjtan qalembzsqh (cjibjfljkw ) View more	Positive	04 Oct 2018
				Insulin regimen	exjyhdjnen(ltetevaigh) = kpjijbyrdb qalembzsqh (cjibjfljkw ) View more

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