Vildagliptin

Generic Name: Vildagliptin

Brand Names: Galvus, Jalra, Xiliarx

Drug Type: Small Molecule

Chemical Formula: C_₁₇H_₂₅N_₃O_₂

CAS Number: 274901-16-5

Unique Ingredient Identifier: I6B4B2U96P

Background: Vildagliptin (LAF237) is an orally active antihyperglycemic agent that selectively inhibits the dipeptidyl peptidase-4 (DPP-4) enzyme. It is used to manage type II diabetes mellitus, where GLP-1 secretion and insulinotropic effects are impaired. By inhibiting DPP-4, vildagliptin prevents the degradation of glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), which are incretin hormones that promote insulin secretion and regulate blood glucose levels. Elevated levels of GLP-1 and GIP consequently results in improved glycemic control. In clinical trials, vildagliptin has a relatively low risk of hypoglycemia.

Oral vildagliptin was approved by the European Medicines Agency in 2008 for the treatment of type II diabetes mellitus in adults as monotherapy or in combination with metformin, a sulfonylurea, or a thiazolidinedione in patients with inadequate glycemic control following monotherapy. It is marketed as Galvus. Vildagliptin is also available as Eucreas, a fixed-dose formulation with metformin for adults in who do not adequately glycemic control from monotherapy. Vildagliptin is currently under investigation in the US.

Indication: Vildagliptin is indicated in the treatment of type II diabetes mellitus in adults. As monotherapy, vildagliptin is indicated in adults inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. It is also indicated as dual therapy in combination with metformin, a sulphonylurea, or a thiazolidinedione in adults patients with insufficient glycemic control despite maximal tolerated dose of monotherapy.

Vildagliptin is also marketed in a combination product with metformin for the treatment of adults with type II diabetes mellitus who inadequately respond to either monotherapy of vildagliptin or metformin. This fixed-dose formulation can be used in combination with a sulphonylurea or insulin (i.e., triple therapy) as an adjunct to diet and exercise in adults who do not achieve adequate glycemic control with monotherapy or dual therapy.

Associated Conditions: Type 2 Diabetes Mellitus

Associated Therapies: -

Clinical Trials

Glycemic Durability After Metformin Failure

Phase 4

Conditions: Type 2 Diabetes

Interventions: Drug: Glimepiride
Drug: Vildagliptin
Drug: Pioglitazone
Drug: Canagliflozin

First Posted Date: 2014-05-20

Last Posted Date: 2016-04-20

Lead Sponsor: University of Campania "Luigi Vanvitelli"

Target Recruit Count: 450

Registration Number: NCT02142309

Locations: 🇮🇹
Department of Geriatrics and Metabolic Diseases, Naples, Italy
🇮🇹
Katherine Esposito, Naples, Italy

DPP-4 Inhibition, Incretins and Islet Function

Phase 4

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Sitagliptin
Drug: Vildagliptin
Drug: Saxagliptin

First Posted Date: 2014-03-17

Last Posted Date: 2017-08-23

Lead Sponsor: Lund University

Target Recruit Count: 24

Registration Number: NCT02089438

Locations: 🇸🇪
Clinical Research Department, Lund, Sweden

Comparison of Vildagliptin vs. Glimepiride on Glucose Variability in Metformin Uncontrolled Type 2 Diabetic Patients

Phase 4

Terminated

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Vildagliptin
Drug: Glimepiride
Drug: Metformin

First Posted Date: 2013-07-29

Last Posted Date: 2015-10-28

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 95

Registration Number: NCT01910441

Safety and Efficacy Study to Compare Vildagliptin to Pioglitazone as Adding on Metformin in Type 2 Diabetes

Phase 4

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: vildagliptin
Drug: Pioglitazone

First Posted Date: 2013-06-21

Last Posted Date: 2019-03-21

Lead Sponsor: Pusan National University Hospital

Target Recruit Count: 287

Registration Number: NCT01882907

Locations: 🇰🇷
Dong-AUniversity Medical Center, Busan, Korea, Republic of
🇰🇷
Changwon Fatima Hospital, Changwon, Korea, Republic of
🇰🇷
Keimyung University Dongsan Medical Center, Daegu, Korea, Republic of

and more 12 locations