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
-

A Study to Assess the Effects of DPP-4 Inhibition on Insulin Sensitivity in Type 2 Diabetes

Phase 3
Completed
Conditions
First Posted Date
2006-07-13
Last Posted Date
2012-05-07
Lead Sponsor
Novartis
Target Recruit Count
12
Registration Number
NCT00351546

Long-Term Safety Study of Vildagliptin in Patients With Type 2 Diabetes

Phase 3
Completed
Conditions
First Posted Date
2006-05-12
Last Posted Date
2009-01-07
Lead Sponsor
Novartis
Target Recruit Count
150
Registration Number
NCT00325429
Locations
🇯🇵

Novartis Pharmaceuticals, Tokyo, Japan

To Assess the Efficacy and Safety of Vildagliptin as Add-on Therapy to Sulfonylurea in Patients With Type 2 Diabetes Inadequately Controlled With Sulfonylurea Monotherapy

Phase 3
Completed
Conditions
First Posted Date
2006-05-12
Last Posted Date
2007-05-14
Lead Sponsor
Novartis
Target Recruit Count
200
Registration Number
NCT00325117
Locations
🇯🇵

Novartis Pharmaceuticals, Tokyo, Japan

A Study to Evaluate the Effects of Vildagliptin on the Insulin Response to Glucose in Subjects With Pre-diabetes

Phase 3
Completed
Conditions
First Posted Date
2006-04-07
Last Posted Date
2016-11-18
Lead Sponsor
Novartis
Target Recruit Count
20
Registration Number
NCT00312130
Locations
🇺🇸

University of Washington, Seattle, Washington, United States

A 56-Week Extension to a Clinical Study to Assess the Efficacy and Safety of Vildagliptin Compared to Placebo in Drug Naive Patients With Type 2 Diabetes and Mild Hyperglycemia

Phase 3
Completed
Conditions
First Posted Date
2006-03-08
Last Posted Date
2017-08-02
Lead Sponsor
Novartis
Target Recruit Count
150
Registration Number
NCT00300287

A Clinical Study to Assess the Effect of Vildagliptin on Beta Cell Function in Drug Naive Patients With Type 2 Diabetes

Phase 3
Completed
Conditions
Interventions
First Posted Date
2005-12-01
Last Posted Date
2020-12-17
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
59
Registration Number
NCT00260156
Locations
🇨🇭

Novartis Pharmaceuticals, Basel, Switzerland

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

Phase 2
Completed
Conditions
First Posted Date
2005-10-13
Last Posted Date
2012-05-02
Lead Sponsor
Novartis
Target Recruit Count
291
Registration Number
NCT00238498

Efficacy and Safety of Vildagliptin in Subjects With Impaired Glucose Tolerance

Phase 3
Completed
Conditions
First Posted Date
2005-10-12
Last Posted Date
2012-05-07
Lead Sponsor
Novartis
Target Recruit Count
171
Registration Number
NCT00237250
Locations
🇺🇸

Novartis Pharmaceuticals, East Hanover, New Jersey, United States

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

Phase 3
Completed
Conditions
First Posted Date
2005-10-12
Last Posted Date
2017-02-07
Lead Sponsor
Novartis
Target Recruit Count
588
Registration Number
NCT00237237
Locations
🇩🇪

Investigative Centers, Nurnberg, Germany

🇺🇸

Novartis Pharmaceuticals, East Hanover, New Jersey, United States

Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Glimepiride in Patients With Type 2 Diabetes

Phase 3
Completed
Conditions
First Posted Date
2005-08-30
Last Posted Date
2017-03-01
Lead Sponsor
Novartis
Target Recruit Count
345
Registration Number
NCT00138580
Locations
🇺🇸

Novartis Pharmaceuticals, East Hanover, New Jersey, United States

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