A Study To Evaluate PF-00915275 In Subjects With Type 2 Diabetes Mellitus For 4-Weeks
NCT00427401
Last updated date
ABOUT THIS STUDY
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).
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Type 2 diabetes mellitus
- HbA1c > 7.5%.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- 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.
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | A Study To Evaluate PF-00915275 In Subjects With Type 2 Diabetes Mellitus For 4-Weeks | |||
| Official Title ICMJE | 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 | |||
| 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). | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 2 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
| Condition ICMJE | Diabetes Mellitus, Type 2 | |||
| Intervention ICMJE | Drug: PF-00915275 | |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Terminated | |||
| Enrollment ICMJE | 40 | |||
| Original Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | June 2007 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Belgium | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00427401 | |||
| Other Study ID Numbers ICMJE | A8441003 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | September 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||