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Vildagliptin AM

Phase 3

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

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

Clinical trial landscape

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 2
NCT00351884370
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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 an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is currently in Phase 3 clinical development, meaning it has not yet been approved by regulatory authorities and remains under investigation for safety and efficacy in patients.

Who makes Vildagliptin AM?

Vildagliptin AM is being developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's potential as a treatment for Type 2 Diabetes Mellitus.

What phase is Vildagliptin AM in?

Vildagliptin AM is currently in Phase 3 clinical development. This stage involves large-scale studies to confirm the drug's efficacy and monitor adverse reactions in a larger patient population. It is an investigational drug and has not yet received regulatory approval for marketing.

What clinical trials is Vildagliptin AM in?

Vildagliptin AM has one completed Phase 3 clinical trial registered under NCT00351884. This randomized, double-blind, placebo-controlled study evaluated the efficacy of Vildagliptin 100 mg as an add-on to metformin in patients with Type 2 Diabetes. The trial enrolled 370 participants across the United States and Germany.

Is Vildagliptin AM the same as Vildagliptin?

Vildagliptin AM is a specific formulation or variant of vildagliptin, a dipeptidyl peptidase-4 inhibitor. While the exact distinction is not specified, the drug name includes 'AM' to differentiate it from other versions. It is being studied for the same indication, Type 2 Diabetes Mellitus.