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A Study To Evaluate PF-00915275 In Subjects With Type 2 Diabetes Mellitus For 4-Weeks

This study has been terminated.
(This study was terminated May 7, 2007. The study stopped due to tablet formulation issues. No safety issues were involved in the termination decision.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00427401
First received: January 25, 2007
Last updated: September 25, 2008
Last verified: September 2008
  Purpose

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).


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: PF-00915275
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The primary end point is glucose lowering (24 hour mean glucose concentration).

Secondary Outcome Measures:
  • Fasting blood glucose

Estimated Enrollment: 40
Study Start Date: February 2007
Study Completion Date: June 2007
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00427401

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00427401     History of Changes
Other Study ID Numbers: A8441003
Study First Received: January 25, 2007
Last Updated: September 25, 2008
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 24, 2014