Study To Compare Single Dose Of Three Modified Release Formulations Of PF-04937319 With Immediate Release Material-Sparing-Tablet (IR MST) Formulation Previously Studied In Adults With Type 2 Diabetes Mellitus.

NCT02206607

Last updated date
Study Location
High Point Clinical Trials Center
High Point, North Carolina, 27265, United States
Contact
1-800-718-1021

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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
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Adults with type 2 diabetes, on stable background metformin therapy either alone or in combination with another oral anti-diabetic agent (OAD) excluding thiazolidinediones (TZDs)

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Patients with cardiovascular event within 6 months of screening


- Patients with diabetic complications


- Female subjects who are pregnant or planning to become pregnant


- Subjects with unstable medical conditions (eg, hypertension)

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study To Compare Single Dose Of Three Modified Release Formulations Of PF-04937319 With Immediate Release Material-Sparing-Tablet (IR MST) Formulation Previously Studied In Adults With Type 2 Diabetes Mellitus.
Official Title  ICMJE A Phase 1, Randomized, Open-label, Cross-over, Single-day Study Of Pf-04937319 To Characterize Relative Bioavailability, Tolerability, And Pharmacodynamics Of Four Oral Formulations In Adults With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
Brief Summary Study B1621015 will characterize bioavailability, tolerability and pharmacodynamics of three modified release formulations of PF-04937319 compared with the immediate release material-sparing-tablet (IR MST) formulation in adults with type 2 diabetes.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: PF-04937319 IR MST
    Immediate release material sparing tablet (IR MST) administered as 150 mg with morning meal and 100 mg with lunch
  • Drug: PF-04937319 MR 1
    Modified release formulation #1 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST
  • Drug: PF-04937319 MR 2
    Modified release formulation #2 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST
  • Drug: PF-04937319 MR 3
    Modified release formulation #3 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST
Study Arms  ICMJE
  • Experimental: PF-04937319 IR MST
    Reference formulation
    Intervention: Drug: PF-04937319 IR MST
  • Experimental: PF-04937319 MR 1
    Test MR #1
    Intervention: Drug: PF-04937319 MR 1
  • Experimental: PF-04937319 MR 2
    Test MR #2
    Intervention: Drug: PF-04937319 MR 2
  • Experimental: PF-04937319 MR 3
    Test MR #3
    Intervention: Drug: PF-04937319 MR 3
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 Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2015)
39
Original Estimated Enrollment  ICMJE
 (submitted: July 30, 2014)
36
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults with type 2 diabetes, on stable background metformin therapy either alone or in combination with another oral anti-diabetic agent (OAD) excluding thiazolidinediones (TZDs)

Exclusion Criteria:

  • Patients with cardiovascular event within 6 months of screening
  • Patients with diabetic complications
  • Female subjects who are pregnant or planning to become pregnant
  • Subjects with unstable medical conditions (eg, hypertension)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02206607
Other Study ID Numbers  ICMJE B1621015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2016

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