Effect of PF-00734200 in Subjects With Type 2 Diabetes | NCT00618007

Official Title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of 12-Week Administration Of PF-00734200 To Subjects With Type 2 Diabetes Mellitus And Insufficient Glycemic Control On Metformin Treatment

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Aug 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

Feb 5, 2008

First Submission Date that Met QC Criteria

Feb 15, 2008

First Posted Date

Feb 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Mar 20, 2009

Certification/Extension First Submitted that Passed QC Review

Sep 24, 2009

Certification/Extension First Posted Date

Sep 28, 2009Estimated

Last Update Submitted Date

Jun 9, 2011

Last Update Posted Date

Jun 27, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To determine the effect of PF-00734200 on HbA1c in type 2 diabetic subjects receiving metformin

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

289Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
30 mg QD	Experimental	Drug: PF-00734200 30 mg QD
20 mg QD	Experimental	Drug: PF-00734200 20 mg QD
Placebo	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PF-00734200 30 mg QD	Drug	30 mg QD	30 mg QD
PF-00734200 20 mg QD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HbA1c		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Fasting Glucose		12 weeks
Fasting Insulin		12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Birmingham	Alabama	35205	United States
Pfizer Investigational Site

References Module

Citations

Not provided

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases