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PF-04937319 once-daily

Phase 1

Type 2 Diabetes Mellitus | Small molecule | Metabolic |Pfizer, Inc.|Last Updated: Sep 27, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment33

FDA Designations

No designations recorded

Clinical trial landscape

PF-04937319 once-daily · 1 trial · 1 indication

Phase 1 1
NCT01933672Study Of Two Dosing Regimens Of PF-04937319 Compared To An Approved Agent (Sitagliptin) In Patients With Type 2 DiabetesType 2 Diabetes Mellitus
COMPLETED33 Analytics
PHASE1COMPLETED
Study Of Two Dosing Regimens Of PF-04937319 Compared To An Approved Agent (Sitagliptin) In Patients With Type 2 Diabetes
Type 2 Diabetes MellitusUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Weighted Mean Daily Glucose (WMDG) at Day 14
Prior to morning dose (Hour 0) and at 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20, and 24 hours post morning dose on Days 0 (baseline) and Day 14

Plasma glucose concentration was determined predose (Hour 0) and at 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20, and 24 hours postdose on Days 0 (baseline) and 14. WMDG was calculated as the area under the curve (AUC) of the 12-point plasma glucose concentration-time profile divided by 24 hours.

Secondary Endpoints

Change From Baseline in Fasting Plasma Glucose (FPG) at Day 14
Day 14
Change From Baseline in Pre-meal C-Peptide on Day 14
Day 14
Change From Baseline in Pre-meal Insulin on Day 14
Day 14
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
PF-04937319 once-dailyEXPERIMENTAL -
PF-04937319 split-doseEXPERIMENTAL -
Sitagliptin once-dailyACTIVE_COMPARATOR -

Interventions

NameTypeDescription
PF-04937319 once-dailyDRUGTablets, 300 mg once-daily with breakfast, 14-days
PF-04937319 split-doseDRUGtablets, 150 mg with breakfast plus 100 mg with lunch, 14-days
Sitagliptin once-dailyDRUGtablets, 100 mg once-daily with breakfast, 14-days
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Patients with type 2 diabetes, on background metformin therapy either alone or with 1 other oral anti-diabetic agent (excluding Actos) Exclusion Criteria: * Patients with cardiovascular event within 6-months of screening * Patients with diabetic complications * Female subjec...

Countries:United States
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Frequently asked questions about PF-04937319 once-daily

What is PF-04937319 used for?

PF-04937319 is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does PF-04937319 target?

The molecular target of PF-04937319 has not been disclosed in available information. It is being studied as a potential treatment for Type 2 Diabetes Mellitus, but its specific mechanism of action is not publicly detailed.

Who is developing PF-04937319?

PF-04937319 is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE.

What phase is PF-04937319 in?

PF-04937319 is in Phase 1 clinical development. It is an investigational drug and has not yet received approval from regulatory agencies for the treatment of Type 2 Diabetes Mellitus.

What clinical trials is PF-04937319 in?

PF-04937319 has been studied in one completed clinical trial, NCT01933672, which evaluated two dosing regimens of the drug compared to sitagliptin in patients with Type 2 Diabetes Mellitus. The trial enrolled 33 participants in the United States.

Is PF-04937319 the same as sitagliptin?

No, PF-04937319 is not the same as sitagliptin. Sitagliptin is an approved agent used as an active comparator in the clinical trial of PF-04937319, which is an investigational drug being studied for Type 2 Diabetes Mellitus.