Study Stopped
This study was terminated May 7, 2007. The study stopped due to tablet formulation issues. No safety issues were involved in the termination decision.
A Study To Evaluate PF-00915275 In Subjects With Type 2 Diabetes Mellitus For 4-Weeks
A Double Blind, Placebo Controlled, Parallel Group Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-00915275 After Oral Administration To Subjects With Type 2 Diabetes Mellitus For 4-Weeks
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of PF-00915275 following administration to adult human subjects with T2DM for 4-weeks. The primary end point is glucose lowering (24 hour mean glucose concentration).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 diabetes-mellitus-type-2
Started Feb 2007
Shorter than P25 for phase_2 diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2007
CompletedFirst Posted
Study publicly available on registry
January 29, 2007
CompletedStudy Start
First participant enrolled
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedSeptember 29, 2008
September 1, 2008
January 25, 2007
September 25, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
The primary end point is glucose lowering (24 hour mean glucose concentration).
Secondary Outcomes (1)
Fasting blood glucose
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 diabetes mellitus
- HbA1c \> 7.5%.
You may not qualify if:
- Recent (within the past 12 months) evidence or history of unstable concomitant disease.
- Treatment with any oral hypoglycemic agent within 3 months before enrollment.
- The exception to these criteria is that subjects who are currently taking metformin hydrochloride, in a stable dose (that is no changes in dose) for treatment of their diabetes within the past 3 months or longer of enrollment may participate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Brussels, 1070, Belgium
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 25, 2007
First Posted
January 29, 2007
Study Start
February 1, 2007
Study Completion
June 1, 2007
Last Updated
September 29, 2008
Record last verified: 2008-09