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PF-00734200

Phase 2

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Pfizer, Inc.|Last Updated: Mar 10, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment592

FDA Designations

No designations recorded

Clinical trial landscape

PF-00734200 · 3 trials · 2 indications

Phase 2 2Phase 1 1
NCT00618007Effect of PF-00734200 in Subjects With Type 2 DiabetesDiabetes Mellitus, Type 2
COMPLETED289 Analytics
NCT0047352512 Week Study Of PF-00734200 For The Treatment Of Type 2 Diabetes Mellitus In Subjects Treated With MetforminDiabetes Mellitus, Type 2
COMPLETED303 Analytics
PHASE2COMPLETED
Effect of PF-00734200 in Subjects With Type 2 Diabetes
Diabetes Mellitus, Type 2Unlock trial analytics
PHASE2COMPLETED
12 Week Study Of PF-00734200 For The Treatment Of Type 2 Diabetes Mellitus In Subjects Treated With Metformin
Diabetes Mellitus, Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

HbA1c
12 weeks
HbA1C levels (%)
12 weeks
Evaluation of Dose Response in HbA1c (%)
12 weeks
Area under the curve from time 0 until last observation (AUCtlast)
3-6 days
Maximum serum concentration (Cmax)
3-6 days

Secondary Endpoints

Fasting Glucose
12 weeks
Fasting Insulin
12 weeks
Insulin and Glucose AUC following a mixed meal tolerance test
12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
30 mg QDEXPERIMENTAL -
20 mg QDEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
PF-00734200 10 mg QDEXPERIMENTAL -
PF-00734200 20 mg QDEXPERIMENTAL -
PF-00734200 5 mg QDEXPERIMENTAL -
PF-00734200 2 mg QDEXPERIMENTAL -
PF-00734200EXPERIMENTAL -

Interventions

NameTypeDescription
PF-00734200 30 mg QDDRUG30 mg QD
PF-00734200 20 mg QDDRUG20 mg QD
PlaceboDRUGPlacebo
PF-00734200 10 mg QDDRUG10 mg QD
PF-00734200 5 mg QDDRUG5 mg QD
PF-00734200 2 mg QDDRUG2 mg QD
PF-00734200DRUGThe drug is administered as a single dose of four 5-mg tablets
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites79

Inclusion Criteria: Men or women between 18-80 years of age with poorly controlled Type 2 diabetes Exclusion Criteria: Type 1 or secondary forms of diabetes Currently using insulin

Countries:United StatesCanadaPuerto RicoSouth KoreaColombiaGermanyItalySpainSweden
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Frequently asked questions about PF-00734200

What is PF-00734200 used for?

PF-00734200 is an investigational small molecule being developed for type 2 diabetes mellitus and chronic renal insufficiency. It has been studied in patients with type 2 diabetes who are also taking metformin, and in subjects with impaired kidney function. The drug is not approved and remains in clinical development.

Who makes PF-00734200?

PF-00734200 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer has sponsored clinical trials of this investigational drug in the United States and several other countries.

What phase is PF-00734200 in?

PF-00734200 is in Phase 2 clinical development for type 2 diabetes mellitus. It has completed two Phase 2 trials and one Phase 1 trial. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials has PF-00734200 been in?

PF-00734200 has been studied in three completed clinical trials. NCT00473525 was a 12-week Phase 2 study in type 2 diabetes patients on metformin with 303 participants. NCT00596518 was a Phase 1 study in 30 subjects with impaired or normal kidney function. NCT00618007 was a Phase 2 study in 289 type 2 diabetes patients.

Is PF-00734200 the same as another drug?

PF-00734200 is the code name used by Pfizer for this investigational compound. No alternative brand names or chemical names have been publicly associated with this drug in the clinical trial records. It is identified solely by its PF-00734200 designation.