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

January 20, 2010
April 21, 2010
February 2010
April 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01054300 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effects Of PF-04971729 In Patients With Type 2 Diabetes
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

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
  • Diabetes Mellitus, Type 2
  • Adult
  • Drug: 2 mg single dose
    2mg dose (using 1mg strength tablets), administered as a single dose
  • Drug: 2 mg split into twice daily
    1 mg dose (using 1 mg strength tablets) administered twice daily x 1 day
  • Drug: 4 mg single dose
    4mg dose (using 1mg strength tablets), administered as a single dose
  • Drug: 4 mg split into twice daily
    2 mg dose (using 1 mg strength tablets) administered twice daily x 1 day
  • Experimental: 2 mg single dose
    Intervention: Drug: 2 mg single dose
  • Experimental: 2 mg split into twice daily
    Intervention: Drug: 2 mg split into twice daily
  • Experimental: 4 mg single dose
    Intervention: Drug: 4 mg single dose
  • Experimental: 4 mg split into twice daily
    Intervention: Drug: 4 mg split into twice daily
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
April 2010
April 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01054300
B1521007
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP