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NCT00427401 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00427401
Other study ID # A8441003
Secondary ID
Status Terminated
Phase Phase 2
First received January 25, 2007
Last updated September 25, 2008
Start date February 2007
Est. completion date June 2007

Study information
Verified date September 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Belgium: Ministry of Social Affairs, Public Health and the Environment
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Terminated
Enrollment 40
Est. completion date June 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• PF-00915275

Locations
Country Name City State
Belgium Pfizer Investigational Site Bruxelles

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary The primary end point is glucose lowering (24 hour mean glucose concentration).
Secondary Fasting blood glucose
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