Back to resultsA Study To Evaluate PF-00915275 In Subjects With Type 2 Diabetes Mellitus For 4-Weeks
Primary Purpose
Diabetes Mellitus, Type 2
Status
Terminated
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
PF-00915275
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- Type 2 diabetes mellitus
- HbA1c > 7.5%.
Exclusion Criteria:
- 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.
Sites / Locations
- Pfizer Investigational Site
Outcomes
Primary Outcome Measures
The primary end point is glucose lowering (24 hour mean glucose concentration).
Secondary Outcome Measures
Fasting blood glucose
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00427401
Brief Title
A Study To Evaluate PF-00915275 In Subjects With Type 2 Diabetes Mellitus For 4-Weeks
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Terminated
Why 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.
Study Start Date
February 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
PF-00915275
Primary Outcome Measure Information:
Title
The primary end point is glucose lowering (24 hour mean glucose concentration).
Secondary Outcome Measure Information:
Title
Fasting blood glucose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetes mellitus
HbA1c > 7.5%.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8441003&StudyName=A%20Study%20To%20Evaluate%20PF-00915275%20In%20Subjects%20With%20Type%202%20Diabetes%20Mellitus%20For%204-Weeks%20
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
A Study To Evaluate PF-00915275 In Subjects With Type 2 Diabetes Mellitus For 4-Weeks
We'll reach out to this number within 24 hrs