Vildagliptin

Generic Name
Vildagliptin
Brand Names
Galvus, Jalra, Xiliarx
Drug Type
Small Molecule
Chemical Formula
C17H25N3O2
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
-

Vildagliptin Compared to Gliclazide in Combination With Metformin in Patients With Type 2 Diabetes

First Posted Date
2005-01-31
Last Posted Date
2020-12-17
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
1007
Registration Number
NCT00102466
Locations
🇩🇪

Investigative Centers, Nurnberg, Germany

🇨🇭

Novartis Pharmaceuticals, Basel, Switzerland

Efficacy and Safety of Vildagliptin Compared to Gliclazide in Drug Naive Patients With Type 2 Diabetes

First Posted Date
2005-01-31
Last Posted Date
2016-11-18
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
1092
Registration Number
NCT00102388
Locations
🇩🇪

Novartis Investigative Site, Investigative Centers, Germany

🇨🇭

Novartis Pharmaceuticals, Basel, Switzerland

Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Drug Naive Patients With Type 2 Diabetes

Phase 3
Completed
Conditions
First Posted Date
2005-01-14
Last Posted Date
2017-05-17
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
527
Registration Number
NCT00101803
Locations
🇺🇸

Novartis Pharmaceuticals, East Hanover, New Jersey, United States

Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With HbA1c 9-11%

Phase 3
Completed
Conditions
First Posted Date
2005-01-13
Last Posted Date
2012-05-07
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
251
Registration Number
NCT00101673
Locations
🇨🇭

Novartis Pharmaceuticals, Basel, Switzerland

Efficacy and Safety of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes and Mild Hyperglycemia

First Posted Date
2005-01-13
Last Posted Date
2012-05-07
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
274
Registration Number
NCT00101712
Locations
🇨🇭

Novartis Investigative Site, Basel, Switzerland

Efficacy and Safety of Vildagliptin in Combination With Glimepiride in Patients With Type 2 Diabetes

First Posted Date
2004-12-22
Last Posted Date
2012-05-07
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
515
Registration Number
NCT00099944
Locations
🇺🇸

Novartis Pharmaceuticals, East Hanover, New Jersey, United States

Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes

First Posted Date
2004-12-22
Last Posted Date
2012-05-07
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
570
Registration Number
NCT00099866
Locations
🇩🇪

Novartis investigative Site, Investigative Sites, Germany

Efficacy and Safety of Vildagliptin in Combination With Insulin in Patients With Type 2 Diabetes

Phase 3
Completed
Conditions
First Posted Date
2004-12-22
Last Posted Date
2012-05-07
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
254
Registration Number
NCT00099931
Locations
🇩🇪

Novartis Investigative Site, Investigative Sites, Germany

A Clinical Study to Assess the Effect of Vildagliptin on Postprandial Lipid Parameters in Patients With Type 2 Diabetes

Phase 2
Completed
Conditions
First Posted Date
2004-12-22
Last Posted Date
2012-05-02
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
38
Registration Number
NCT00099957
Locations
🇨🇭

Novartis Pharmaceuticals, Basel, Switzerland

A Clinical Study to Assess the Efficacy and Safety of Three Doses of Vildagliptin in Patients With Type 2 Diabetes

Phase 3
Completed
Conditions
First Posted Date
2004-12-22
Last Posted Date
2012-05-02
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
639
Registration Number
NCT00099905
Locations
🇺🇸

Novartis Pharmaceuticals, East Hanover, New Jersey, United States

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