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PF-00734200

Phase 2

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

PF-00734200 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Jan 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment622

FDA Designations

No designations recorded

PF-00734200 clinical trials

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?

PF-00734200 is an investigational small molecule developed by Pfizer for metabolic conditions. It has been studied in Phase 2 clinical trials for type 2 diabetes mellitus and in a Phase 1 trial for chronic renal insufficiency. It is not approved and remains in clinical development.

What is PF-00734200 used for in type 2 diabetes?

PF-00734200 has been evaluated as a treatment for type 2 diabetes mellitus. Two completed Phase 2 trials studied it in adults with the condition, including one in patients already treated with metformin. It is investigational and has not been approved for any use.

Who makes PF-00734200?

PF-00734200 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the clinical trials of the drug in type 2 diabetes and chronic renal insufficiency.

What phase is PF-00734200 in?

PF-00734200 is in Phase 2 development. Two Phase 2 trials and one Phase 1 trial have been completed, and no trials are currently active. The drug is investigational and has not received FDA approval.

What clinical trials is PF-00734200 in?

PF-00734200 has been studied in completed trials including NCT00618007, a Phase 2 trial in type 2 diabetes with 289 participants, NCT00473525, a 12-week Phase 2 trial in type 2 diabetes patients on metformin with 303 participants, and NCT00596518, a Phase 1 trial in chronic renal insufficiency with 30 participants.