Numerous clinical trials evaluate the efficacy, pharmacokinetics, and safety of vildagliptin in managing type 2 diabetes mellitus and related metabolic conditions. Ranging from Phase 1 pharmacokinetic studies to Phase 3 and Phase 4 trials assessing glycemic control and cardiovascular outcomes, these studies encompass completed, active, recruiting, and withdrawn recruitment statuses. Sponsorship is provided by major pharmaceutical corporations, such as Novartis and Hanmi Pharmaceutical, alongside academic institutions including Al-Azhar University.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT03925701 | RECRUITING | dm |
Sherief Abd-Elsalam |
2019-04-01 | PHASE3 |
| NCT06951334 | NOT_YET_RECRUITING | Parkinson's Disease |
First Affiliated Hospital, Sun Yat-Sen University |
2025-06-01 | |
| NCT05366868 | ACTIVE_NOT_RECRUITING | Diabetes Mellitus, Type 2 |
National Center for Global Health and Medicine, Japan |
2022-05-26 | PHASE4 |
| NCT06851962 | COMPLETED | Diabetes Mellitus Type 2 |
Fundación para la Investigación del Hospital Clínico de Valencia |
2025-05-26 | PHASE4 |
| NCT04761861 | WITHDRAWN | Schizophrenia; Dyslipidemias |
Sadat City University |
2021-02-16 | PHASE2 |
| NCT06142656 | RECRUITING | Poly Cystic Ovary Syndrome |
October 6 University |
2023-11-25 | PHASE2; PHASE3 |
| NCT06889909 | ACTIVE_NOT_RECRUITING | Type 2 Diabetes Mellitus (T2DM) |
Lahore General Hospital |
2024-12-15 | |
| NCT06913101 | ACTIVE_NOT_RECRUITING | Type 2 Diabetes Mellitus (T2DM) |
PNS Hafeez - Naval Hospital |
2024-11-15 | |
| NCT04410341 | WITHDRAWN | Major Depressive Disorder |
Sadat City University |
2020-05-01 | PHASE1; PHASE2 |
| NCT06068686 | COMPLETED | Type 2 Diabetes |
Damanhour University |
2022-10-01 | |
| NCT06248801 | UNKNOWN | Healthy Subjects |
Bio-innova Co., Ltd |
2024-09-05 | PHASE1 |
| NCT06313008 | COMPLETED | Coronary Artery Disease; Type 2 Diabetes |
Damanhour University |
2023-08-10 | |
| NCT07077525 | COMPLETED | Type 2 Diabetes |
Al-Azhar University |
2023-06-01 | PHASE4 |
| NCT02849899 | UNKNOWN | Disorder Related to Renal Transplantation; Diabetes |
Centre Hospitalier Universitaire de Besancon |
2018-10-26 | PHASE3 |
| NCT06244407 | UNKNOWN | Healthy Volunteer |
International Bio service |
2024-05-23 | PHASE1 |
| NCT04841096 | COMPLETED | Type 2 Diabetes |
Laboratorios Silanes S.A. de C.V. |
2023-03-21 | PHASE3 |
| NCT05102149 | UNKNOWN | Type 2 Diabetes Mellitus (T2DM) |
PegBio Co., Ltd. |
2021-09-30 | PHASE3 |
| NCT06103747 | COMPLETED | Fed Conditions |
Reseach Laboratory of Clinical and Experimental Pharmacology |
2023-02-21 | PHASE1 |
| NCT06073600 | COMPLETED | Fed Conditions |
Reseach Laboratory of Clinical and Experimental Pharmacology |
2022-05-20 | PHASE1 |
| NCT04300790 | COMPLETED | Breast Cancer |
MedSIR |
2020-10-23 | PHASE2 |
| NCT05041673 | UNKNOWN | Fatty Liver, Nonalcoholic; Diabetes Mellitus, Type 2 |
Alexandria University |
2021-02-23 | |
| NCT05359432 | COMPLETED | Type 2 Diabetes |
Getz Pharma |
2020-07-01 | PHASE4 |
| NCT04485845 | UNKNOWN | Metabolic Syndrome; Diabete Type 2; Kidney Insufficiency |
Cairo University |
2019-11-01 | PHASE4 |
| NCT04916093 | COMPLETED | Diabetes Mellitus, Type 2 |
Beni-Suef University |
2019-12-20 | PHASE4 |
| NCT03693560 | COMPLETED | Coronary Artery Disease; Diabetes Mellitus, Type 2 |
Damanhour University |
2018-10-08 | PHASE4 |
| NCT04654676 | COMPLETED | Diabetes Mellitus, Type 2 |
University Malaysia Sarawak |
2018-09-15 | PHASE4 |
| NCT03563794 | UNKNOWN | T2DM |
The First Affiliated Hospital of Xiamen University |
2018-06-10 | PHASE4 |
| NCT04081857 | Completed | Health Subjective |
Hanmi Pharmaceutical Company Limited |
2019-06-03 | Phase 1 |
| NCT01528254 | COMPLETED | Type 2 Diabetes Mellitus |
Novartis Pharmaceuticals |
2012-03-30 | PHASE4 |
| NCT02803892 | COMPLETED | Diabetes Mellitus, Type 1 |
Piemonti Lorenzo |
2016-05 | PHASE2 |
| NCT04087525 | Completed | Health Subjective |
Hanmi Pharmaceutical Company Limited |
2018-10-23 | Phase 1 |
| NCT03178591 | COMPLETED | Diabetes Mellitus, Type 2; Ischemic Heart Disease |
Chiang Mai University |
2014-10 | PHASE4 |
| NCT03577184 | Withdrawn | Diabetes Mellitus Type 2 |
Clinision |
2018-07 | -- |
| NCT02999841 | UNKNOWN | Diabetes Mellitus, Type 2; Obesity |
Peking University |
2016-03 | PHASE4 |
| NCT02853630 | COMPLETED | TYpe 2 Diabetes Mellitus |
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals |
2013-12 | PHASE4 |
| NCT02176681 | COMPLETED | Haemodialyzed, Type 2 Diabetes |
University Hospital, Strasbourg, France |
2014-06 | PHASE4 |
| NCT03253562 | COMPLETED | Reducing the Elevated Blood Pressure for Diabetic Hypertensive Patients |
MTI University |
2017-02-01 | PHASE4 |
| NCT04237493 | COMPLETED | Diabetes Mellitus, Type 2 |
University of Jordan |
2017-02-14 | PHASE4 |
| NCT02089438 | COMPLETED | Type 2 Diabetes |
Lund University |
2014-05 | PHASE4 |
| NCT02475070 | COMPLETED | Type 2 Diabetes |
Lund University |
2016-01 | PHASE4 |
| NCT03500900 | COMPLETED | Healthy |
Universitaire Ziekenhuizen KU Leuven |
2016-03-01 | |
| NCT01703637 | UNKNOWN | Type 2 Diabetes Mellitus |
Lin Liao |
2012-10 | |
| NCT02832999 | COMPLETED | Type 2 Diabetes Mellitus |
Yaounde Central Hospital |
2016-01 | PHASE4 |
| NCT03819127 | COMPLETED | Mild Cognitive Impairment |
University of Catania |
2015-01 | PHASE4 |
| NCT01827280 | COMPLETED | 1- Microvascular Function; 2-oxidative Stress; 3-inflammation |
Rio de Janeiro State University |
2013-04 | PHASE4 |
| NCT02145611 | COMPLETED | Type 2 Diabetes Mellitus; Hypertension; Endothelial Dysfunction |
Dr. José Fernando Vilela-Martin MD PhD |
2013-07 | PHASE4 |
| NCT02343926 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2014-12 | PHASE3 |
| NCT01604213 | COMPLETED | Type 2 Diabetes Mellitus; Ischemic Heart Disease |
Sheba Medical Center |
2012-09 | PHASE4 |
| NCT02007278 | COMPLETED | Type 2 Diabetes; Hypoglycemia |
Novartis Pharmaceuticals |
2014-01-03 | PHASE4 |
| NCT05329857 | COMPLETED | To Determine Bioequivalence Under Fed Conditions |
AET Laboratories Private Limited |
2015-12 | |
| NCT01472432 | COMPLETED | Chronic Foot Ulcers |
University of Campania Luigi Vanvitelli |
2011-05 | PHASE4 |
| NCT05337969 | Completed | To Determine Bioequivalence Under Fed Conditions |
AET Laboratories Private Limited|Alfred E. Tiefenbacher (GmbH & Co. KG) |
2015-12 | Not Applicable |
| NCT05329857 | Completed | To Determine Bioequivalence Under Fed Conditions |
AET Laboratories Private Limited|Alfred E. Tiefenbacher (GmbH & Co. KG) |
2015-12 | Not Applicable |
| NCT05337969 | COMPLETED | To Determine Bioequivalence Under Fed Conditions |
AET Laboratories Private Limited |
2015-12 | |
| NCT01766778 | COMPLETED | Type-2 Diabetes Mellitus |
Novartis Pharmaceuticals |
2013-05-13 | PHASE4 |
| NCT01679899 | COMPLETED | Type 2 Diabetes Mellitus; Menopause; Osteoporosis; Osteopenia |
Centro de Diabetes Curitiba Ltda |
2012-12 | PHASE4 |
| NCT02142309 | UNKNOWN | Type 2 Diabetes |
University of Campania Luigi Vanvitelli |
2005-10 | PHASE4 |
| NCT01582243 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2013-04 | PHASE4 |
| NCT01867502 | UNKNOWN | Diabetes Mellitus, Type 2; Hypoglycemic Agents; Diabetic Blood Glucose Monitoring; Exercise |
Hospital de Clinicas de Porto Alegre |
2014-04 | PHASE4 |
| NCT01812122 | COMPLETED | Diabetes Mellitus, Non-Insulin-Dependent |
Seoul National University Hospital |
2013-03 | PHASE4 |
| NCT01862263 | TERMINATED | Type 2 Diabetes Mellitus |
Novartis Pharmaceuticals |
2013-05 | PHASE4 |
| NCT01757587 | COMPLETED | Type 2 Diabetes |
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète |
2011-12 | PHASE4 |
| NCT01559025 | UNKNOWN | Type 1 Diabetes; Insulin Dependent Diabetes; Juvenile Onset Diabetes Mellitus; Autoimmune Diabetes |
Federal University of São Paulo |
2014-03 | PHASE3 |
| NCT02002221 | COMPLETED | Type 2 Diabetes Mellitus (T2DM) |
Novartis Pharmaceuticals |
2013-12 | PHASE4 |
| NCT01871558 | COMPLETED | Type 2 Diabetes Mellitus (T2DM) |
Novartis Pharmaceuticals |
2013-06 | PHASE3 |
| NCT01822548 | COMPLETED | Type 2 Diabetes |
Azienda Ospedaliero-Universitaria di Parma |
2010-10 | PHASE3 |
| NCT01686932 | COMPLETED | Diabetes Mellitus Type 2 |
Novartis Pharmaceuticals |
2012-11 | PHASE4 |
| NCT01910441 | TERMINATED | Type 2 Diabetes Mellitus |
Novartis Pharmaceuticals |
2013-07 | PHASE4 |
| NCT01122641 | COMPLETED | Insulin Resistance; Microvascular Disease |
Royal Devon and Exeter NHS Foundation Trust |
2010-05 | PHASE3 |
| NCT03088670 | COMPLETED | Diabetes Mellitus, Type 2 |
SatRx LLC |
2013-04-23 | PHASE3 |
| NCT05329844 | COMPLETED | Diabetes Mellitus |
AET Laboratories Private Limited |
2014-02 | |
| NCT02749032 | COMPLETED | Type 2 Diabetes |
Michael A. Nauck |
2011-11 | PHASE1 |
| NCT02816970 | COMPLETED | Healthy |
Genuine Research Center, Egypt |
2014-02 | PHASE1 |
| NCT01811485 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2013-05 | PHASE3 |
| NCT01541956 | COMPLETED | Type 2 Diabetes |
Novartis Pharmaceuticals |
2012-02 | PHASE4 |
| NCT01219400 | COMPLETED | Diabetes |
Lund University |
2012-01 | PHASE4 |
| NCT01649466 | COMPLETED | Type 2 Diabetes Mellitus |
Novartis Pharmaceuticals |
2012-08 | PHASE4 |
| NCT01758380 | COMPLETED | Type 2 Diabetes Mellitus |
Novartis Pharmaceuticals |
2013-01 | PHASE4 |
| NCT01356381 | COMPLETED | Type 2 Diabetes Mellitus |
Novartis Pharmaceuticals |
2011-04 | PHASE4 |
| NCT01582230 | COMPLETED | Type 2 Diabetes Mellitus |
Novartis Pharmaceuticals |
2012-04 | PHASE3 |
| NCT01882907 | COMPLETED | Type 2 Diabetes |
Pusan National University Hospital |
2009-12 | PHASE4 |
| NCT01497522 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2011-12 | PHASE3 |
| NCT01452113 | COMPLETED | Diabetes Mellitus |
University Hospital, Toulouse |
2010-10 | PHASE2 |
| NCT01357252 | COMPLETED | Type 2 Diabetes Mellitus |
Novartis Pharmaceuticals |
2011-04 | PHASE3 |
| NCT01426737 | UNKNOWN | Type 2 Diabetes |
University of Zurich |
2011-04 | PHASE4 |
| NCT01582308 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2012-06-21 | PHASE1 |
| NCT01339143 | UNKNOWN | Diabetes Mellitus; Oxidative Stress |
Korea University Anam Hospital |
2010-04 | PHASE4 |
| NCT01099137 | COMPLETED | Diabetes |
Seoul National University Bundang Hospital |
2010-01 | PHASE4 |
| NCT01565096 | UNKNOWN | Diabetes Mellitus Type II |
ikfe-CRO GmbH |
2011-11 | PHASE4 |
| NCT01537120 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2011-12 | PHASE1 |
| NCT01518101 | COMPLETED | Type 2 Diabetes |
Novartis Pharmaceuticals |
2012-01 | PHASE4 |
| NCT00980356 | COMPLETED | Diabetes Mellitus |
Medical University of Vienna |
2009-09 | PHASE2 |
| NCT00894868 | COMPLETED | Congestive Heart Failure; Type II Diabetes Mellitus |
Novartis Pharmaceuticals |
2009-05 | PHASE4 |
| NCT01018602 | UNKNOWN | Insulin-dependent Gestational Diabetes |
Institut fur Diabetesforschung, Munich, Germany |
2008-01 | PHASE2 |
| NCT01398592 | COMPLETED | Diabetes Mellitus Type 2 |
Novartis Pharmaceuticals |
2011-06 | PHASE4 |
| NCT01404676 | COMPLETED | Type 2 Diabetes Mellitus |
Samsung Medical Center |
2010-06 | PHASE4 |
| NCT01257451 | COMPLETED | Type 2 Diabetes Mellitus |
Novartis Pharmaceuticals |
2010-12 | PHASE3 |
| NCT01159249 | COMPLETED | Type 2 Diabetes |
Novartis Pharmaceuticals |
2010-06 | PHASE3 |
| NCT01238978 | COMPLETED | Type 2 Diabetes Mellitus; Elderly |
Novartis |
2010-10 | PHASE4 |
| NCT00975065 | COMPLETED | Type 2 Diabetes Mellitus |
Handok Inc. |
2009-08 | PHASE4 |
| NCT01346254 | COMPLETED | Impaired Glucose Tolerance; Kidney Transplantation |
Marcus Saemann |
2009-12 | PHASE2 |
| NCT01233622 | COMPLETED | Type 2 Diabetes Mellitus |
Novartis |
2010-10 | PHASE3 |
| NCT01196546 | COMPLETED | Type 2 Diabetes Mellitus |
Novartis |
2010-03 | PHASE4 |
| NCT01224366 | COMPLETED | Type 2 Diabetes Mellitus |
Novartis |
2010-09 | PHASE3 |
| NCT00936234 | WITHDRAWN | SDF-1 is an Important Cytokine for Neovascularization. Cleavage of SDF-1 is Reduced by DPPIV Inhibitors |
Johann Wolfgang Goethe University Hospital |
2009-07 | PHASE2; PHASE3 |
| NCT01147276 | COMPLETED | Diabetes; Hypoglycemia |
Lund University |
2010-09 | PHASE4 |
| NCT01193296 | COMPLETED | Type 2 Diabetes Mellitus |
Novartis |
2010-06 | PHASE4 |
| NCT00770081 | COMPLETED | Diabetes Mellitus, Type 2; Renal Insufficiency |
Novartis |
2008-09 | PHASE3 |
| NCT01309698 | COMPLETED | Type 2 Diabetes |
Novartis Pharmaceuticals |
2011-02 | PHASE4 |
| NCT01426802 | COMPLETED | Type 2 Diabetes Mellitus |
Novartis Pharmaceuticals |
2010-10 | PHASE4 |
| NCT00765830 | COMPLETED | Diabetes Mellitus, Type 2; Renal Insufficiency |
Novartis |
2008-09 | PHASE3 |
| NCT00860288 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2009-02 | PHASE2; PHASE3 |
| NCT01262586 | COMPLETED | Type II Diabetes Mellitus |
Novartis Pharmaceuticals |
2010-11 | PHASE3 |
| NCT00821977 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis |
2008-11 | PHASE2; PHASE3 |
| NCT00616811 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis |
2008-01 | PHASE3 |
| NCT00646542 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis |
2005-03 | PHASE3 |
| NCT01000688 | COMPLETED | Type 2 Diabetes; Endothelial Dysfunction |
Radboud University Medical Center |
2010-01 | PHASE3 |
| NCT00728351 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2008-06 | PHASE3 |
| NCT02639130 | COMPLETED | Type 2 Diabetes |
Diabeteszentrum Bad Lauterberg im Harz |
2008-02 | PHASE4 |
| NCT00822211 | COMPLETED | Type 2 Diabetes Mellitus |
Novartis |
2008-12 | PHASE3 |
| NCT00651105 | COMPLETED | Type-2 Diabetes; Healthy |
Novartis |
2008-02 | PHASE3 |
| NCT00818571 | COMPLETED | Renal Impairment; Diabetes |
Novartis Pharmaceuticals |
2008-12 | PHASE1; PHASE2 |
| NCT00567047 | COMPLETED | Type-2 Diabetes |
Novartis |
2007-07 | PHASE1 |
| NCT00102466 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2005-01 | PHASE3 |
| NCT00633997 | TERMINATED | Diabetes Mellitus, Type 2 |
Novartis |
2008-02 | PHASE1; PHASE2 |
| NCT00260156 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2005-11 | PHASE3 |
| NCT00494884 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis |
2007-06 | PHASE3 |
| NCT00468039 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis |
2007-03-06 | PHASE3 |
| NCT00382096 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2006-09 | PHASE3 |
| NCT00396357 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2006-10 | PHASE3 |
| NCT00106340 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2005-03 | PHASE3 |
| NCT00383578 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2006-09 | PHASE3 |
| NCT00102388 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2005-01 | PHASE3 |
| NCT00099853 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2004-05 | PHASE3 |
| NCT00396071 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2006-10 | PHASE3 |
| NCT00351884 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2006-05 | PHASE3 |
| NCT00572650 | COMPLETED | Type 2 Diabetes Mellitus |
Novartis |
2007-10 | PHASE1 |
| NCT00396227 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2006-10 | PHASE3 |
| NCT00390520 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis |
2006-09 | PHASE3 |
| NCT00300287 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis |
2006-02-20 | PHASE3 |
| NCT00380445 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis |
2006-01 | PHASE3 |
| NCT00138619 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis |
2004-11 | PHASE3 |
| NCT00237237 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis |
2005-10 | PHASE3 |
| NCT00312130 | COMPLETED | Pre-diabetes |
Novartis |
2005-04 | PHASE3 |
| NCT00380380 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis |
2006-01 | PHASE3 |
| NCT00110240 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2005-04 | PHASE3 |
| NCT00138567 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis |
2005-01 | PHASE3 |
| NCT00120536 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis |
2005-06 | PHASE3 |
| NCT00138593 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis |
2004-07 | PHASE3 |
| NCT00237250 | COMPLETED | Prediabetic State |
Novartis |
2005-10 | PHASE3 |
| NCT00138554 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis |
2004-11 | PHASE3 |
| NCT00101712 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2004-10 | PHASE3 |
| NCT00138515 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis |
2004-11 | PHASE3 |
| NCT00138541 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis |
2004-10 | PHASE3 |
| NCT00138580 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis |
2004-11 | PHASE3 |
| NCT00952991 | COMPLETED | Diabetes Mellitus, Non-Insulin-Dependent |
Mayo Clinic |
2005-05 | PHASE3 |
| NCT00351507 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2005-05 | PHASE3 |
| NCT00101803 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2005-01 | PHASE3 |
| NCT00138606 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis |
2005-01 | PHASE3 |
| NCT00351546 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis |
2005-02 | PHASE3 |
| NCT00099905 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2004-04 | PHASE3 |
| NCT00099944 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2004-05 | PHASE3 |
| NCT00351585 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis |
2004-07 | PHASE3 |
| NCT00099918 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2004-05 | PHASE3 |
| NCT00099892 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2004-05 | PHASE3 |
| NCT00099866 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2004-01 | PHASE3 |
| NCT00238498 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis |
2004-07 | PHASE2 |
| NCT00099957 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2003-09 | PHASE2 |
| NCT00099931 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2004-05 | PHASE3 |
| NCT00101673 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis Pharmaceuticals |
2004-03 | PHASE3 |
| NCT00419887 | COMPLETED | Healthy |
Novartis |
2006-09 | PHASE1 |
| NCT00389415 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis |
2006-10 | PHASE3 |
| NCT00414947 | COMPLETED | Healthy |
Novartis |
2006-12 | PHASE1 |
| NCT00351832 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis |
2006-06 | PHASE3 |
| NCT00368134 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis |
2006-08 | PHASE3 |
| NCT00325429 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis |
2006-04 | PHASE3 |
| NCT00325117 | COMPLETED | Diabetes Mellitus, Type 2 |
Novartis |
2006-04 | PHASE3 |
(data from https://clinicaltrials.gov, updated on 2019-04-29)
Check the
Vildagliptin
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.