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Vildagliptin AM

Phase 3

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Novartis AG|Trials Updated: Nov 18, 2016

Vildagliptin AM development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Jul 2006

Vildagliptin AM target and mechanism

Molecular targetDPP4
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment370

FDA Designations

No designations recorded

Vildagliptin AM clinical trials

Vildagliptin AM · 1 trial · 1 indication

Phase 3 1
NCT00351884Efficacy of Vildagliptin 100 MG as Compared to Placebo as Add-on to Metformin in Patients With Type 2 DiabetesDiabetes Mellitus, Type 2
COMPLETED370 Analytics
PHASE3COMPLETED
Efficacy of Vildagliptin 100 MG as Compared to Placebo as Add-on to Metformin in Patients With Type 2 Diabetes
Diabetes Mellitus, Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in HbA1c at 24 weeks
24 weeks

Secondary Endpoints

Safety of vildagliptin in combination with metformin during 24 weeks of treatment
24 weeks
Change from baseline in fasting plasma glucose at 24 weeks
24 weeks
Patients with endpoint HbA1c < 7% after 24 weeks
24 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
vildagliptin amEXPERIMENTAL -
vildagliptin pmEXPERIMENTAL -
placeboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Vildagliptin AMDRUG -
vildagliptin pmDRUG -
placeboDRUG -
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Eligibility Criteria

Age Range18 Years to 78 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Patients on metformin for at least three months and on a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1 * Body mass index in the range 22-40 * Blood glucose criteria must be met Exclusion Criteria: * Pregnancy or lactation * History of type 1...

Countries:United StatesGermany
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Frequently asked questions about Vildagliptin AM

What is Vildagliptin AM used for?

Vildagliptin AM is being developed for the treatment of type 2 diabetes mellitus. It is a small molecule DPP4 inhibitor studied as an add-on therapy to metformin in adult patients whose blood glucose is not adequately controlled. The program is in Phase 3 development and is sponsored by Novartis AG.

What does Vildagliptin AM target?

Vildagliptin AM targets DPP4, also known as dipeptidyl peptidase-4. It acts as a DPP4 inhibitor, a class of oral small molecule agents used in type 2 diabetes. By inhibiting this enzyme, the drug belongs to the DPP4 inhibitor therapeutic class. The molecular target is listed in ChEMBL under identifier CHEMBL142703.

Who makes Vildagliptin AM?

Vildagliptin AM is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the clinical program for this DPP4 inhibitor in type 2 diabetes mellitus. The asset sits within the metabolic therapeutic area.

What phase is Vildagliptin AM in?

Vildagliptin AM is in Phase 3 development for type 2 diabetes mellitus. It is an investigational small molecule DPP4 inhibitor and is not described as approved. The Phase 3 program includes one completed trial, and no active trials are currently listed for this asset.

What clinical trials is Vildagliptin AM in?

Vildagliptin AM has been studied in the Phase 3 trial NCT00351884, titled Efficacy of Vildagliptin 100 MG as Compared to Placebo as Add-on to Metformin in Patients With Type 2 Diabetes. That trial enrolled 370 adults, was randomized, double-blind, and placebo-controlled, and was conducted in the United States and Germany. It is now completed.