Effects Of PF-04971729 In Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01054300
First received: January 20, 2010
Last updated: April 21, 2010
Last verified: April 2010
  Purpose

This is a Phase 1 study to understand the manner in which the body responds to, as well as how the drug is handled by the body, with once vs twice daily dosing of PF-04971729 in patients with type 2 diabetes.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Adult
Drug: 2 mg single dose
Drug: 2 mg split into twice daily
Drug: 4 mg single dose
Drug: 4 mg split into twice daily
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, 2-Period, Cross-Over Single Day Evaluation Of The Pharmacokinetic-Pharmacodynamic Effect Of Once And Twice Daily Oral Administration Of PF-04971729 In Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Pharmacodynamic Effect - 24hr as well as time course over intervals of 0-4, 4-8, 8-12 and 12-24hr, of urinary glucose excretion (UGE) and 24-hr mean plasma glucose, fasting plasma glucose and C-peptide [ Time Frame: 3-weeks ] [ Designated as safety issue: No ]
  • Safety and Tolerability - adverse events, serious adverse events, clinical lab tests, vitals, 12-lead electrocardiograms [ Time Frame: 3-weeks ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics - Area-under-the-curve from 1st dose to last PK collection in each period (AUClast), maximum plasma concentration (Cmax), and time of Cmax (Tmax) [ Time Frame: 3-weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetic (PK) - pharmacodynamics (PD) - relationship, if any, between PF-04971729 PK and selected PD endpoints [ Time Frame: 3-weeks ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: February 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2 mg single dose Drug: 2 mg single dose
2mg dose (using 1mg strength tablets), administered as a single dose
Experimental: 2 mg split into twice daily Drug: 2 mg split into twice daily
1 mg dose (using 1 mg strength tablets) administered twice daily x 1 day
Experimental: 4 mg single dose Drug: 4 mg single dose
4mg dose (using 1mg strength tablets), administered as a single dose
Experimental: 4 mg split into twice daily Drug: 4 mg split into twice daily
2 mg dose (using 1 mg strength tablets) administered twice daily x 1 day

Detailed Description:

Phase 1 PK-PD study to understand the body's response to twice daily versus once daily dosing of PF-04971729. This study also plans to study how the body handles PF-04971729.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with type 2 diabetes, on up to 2 acceptable oral anti-diabetes drugs for at least 8-weeks prior to study.

Exclusion Criteria:

  • Patients with type 1 diabetes, patients with stroke, unstable angina, heart attack in last 6-months, uncontrolled blood pressure.
  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: NCT01054300

Locations
United States, California
Pfizer Investigational Site
Chula Vista, California, United States, 91911
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
United States, Florida
Pfizer Investigational Site
Miami Gardens, Florida, United States, 33169
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01054300     History of Changes
Other Study ID Numbers: B1521007
Study First Received: January 20, 2010
Last Updated: April 21, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 01, 2014