- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00427401
A Study To Evaluate PF-00915275 In Subjects With Type 2 Diabetes Mellitus For 4-Weeks
September 25, 2008 updated by: Pfizer
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
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).
Study Overview
Study Type
Interventional
Enrollment
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bruxelles, Belgium, 1070
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The primary end point is glucose lowering (24 hour mean glucose concentration).
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Secondary Outcome Measures
Outcome Measure |
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Fasting blood glucose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Study Completion (Actual)
June 1, 2007
Study Registration Dates
First Submitted
January 25, 2007
First Submitted That Met QC Criteria
January 25, 2007
First Posted (Estimate)
January 29, 2007
Study Record Updates
Last Update Posted (Estimate)
September 29, 2008
Last Update Submitted That Met QC Criteria
September 25, 2008
Last Verified
September 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A8441003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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