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Vildagliptin

Phase 4

Type 2 Diabetes Mellitus | Small molecule | Metabolic |Merck & Company, Inc.|Trials Updated: Aug 19, 2015

Vildagliptin development status

Highest phase Phase 4 run by Novartis Pharmaceuticals (NCT00894868)
Phase scored for MRKPhase 1
Registered trials 86 across 9 sponsors since Dec 2004

Vildagliptin target and mechanism

Molecular targetDPP4
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Vildagliptin clinical trials

Vildagliptin · 1 trial · 1 indication

Phase 1 1
NCT01537120Evaluation of Continuous Glucose Monitoring in Participants With Type 2 Diabetes Mellitus (MK-0000-258 AM2)Type 2 Diabetes Mellitus
COMPLETED25 Analytics
PHASE1COMPLETED
Evaluation of Continuous Glucose Monitoring in Participants With Type 2 Diabetes Mellitus (MK-0000-258 AM2)
Type 2 Diabetes MellitusUnlock trial analytics

Study Endpoints

Primary Endpoints

24 Hour Weighted Mean Glucose (WMG) At 2 Weeks
At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatment

The 24 hour WMG was measured after 2 weeks of placebo treatment, and again after 2 weeks of vildagliptin treatment. Glucose was measured over a 24 hour period by having participants wear two continuous glucose monitors (CGM), which produced an average glucose value approximately every 5 minutes. Using these values, the concentration of glucose was calculated from Area Under the Curve 0-24 hours (AUC 0-24hr), and was expressed as 24 hour WMG.

Secondary Endpoints

Hemoglobin A1C (HbA1C) At 2 Weeks
At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatment
HbA1C At 12 Weeks
At 2 weeks after Placebo treatment and again at 12 weeks after Vildagliptin treatment
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Study Design & Arms

AllocationNA
MaskingSINGLE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Placebo → VildagliptinEXPERIMENTALParticipants received placebo tablets orally, twice a day for 3 weeks, and then over the next 12 weeks received vildagliptin 50 mg tablets orally, twice daily

Interventions

NameTypeDescription
VildagliptinDRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 79 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Clinical diagnosis of type 2 diabetes mellitus on a clinical regimen that is metformin alone, up to a maximum of 3 gram per day, on a background of lifestyle measures, and has a Hemoglobin A1C at screening of \> 7%. * If on antihyperglycemic therapy with both metformin and sul...

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Frequently asked questions about Vildagliptin

What is Vildagliptin used for?

Vildagliptin is being studied for the treatment of Type 2 Diabetes Mellitus. It is an investigational small molecule developed by Merck & Company, Inc. (MRK) and has been evaluated in a Phase 1 clinical trial. It is not approved for any indication.

What does Vildagliptin target?

Vildagliptin targets DPP4 (dipeptidyl peptidase-4). It is a DPP4 inhibitor, meaning it works by inhibiting the DPP4 enzyme. This mechanism is being investigated for its effects in Type 2 Diabetes Mellitus.

Who is developing Vildagliptin?

Vildagliptin is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is responsible for the clinical development of this investigational therapy for Type 2 Diabetes Mellitus.

What phase is Vildagliptin in?

Vildagliptin is in Phase 1 clinical development. It has completed one Phase 1 trial and is not currently active in any trials. It is an investigational drug and has not been approved by the FDA for any indication.

What clinical trials is Vildagliptin in?

Vildagliptin has been evaluated in one completed Phase 1 clinical trial: NCT01537120, titled "Evaluation of Continuous Glucose Monitoring in Participants With Type 2 Diabetes Mellitus (MK-0000-258 AM2)." The trial enrolled 25 participants with Type 2 Diabetes Mellitus and was uncontrolled, non-randomized, and not double-blind.