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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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00427401
Enrollment
40
Registered
2007-01-29
Start date
2007-02-28
Completion date
2007-06-30
Last updated
2008-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

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).

Interventions

DRUGPF-00915275

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
The primary end point is glucose lowering (24 hour mean glucose concentration).

Secondary

MeasureTime frame
Fasting blood glucose

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026