Study Of Two Dosing Regimens Of PF-04937319 Compared To An Approved Agent (Sitagliptin) In Patients With Type 2 Diabetes

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NCT01933672

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Study Location
Avail Clinical Research, LLC
DeLand, Florida, 32720, United States
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Contact
1-800-718-1021
[email protected]
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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.
Show details

- Patients with type 2 diabetes, on background metformin therapy either alone or with 1 other oral anti-diabetic agent (excluding Actos)

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 Of Two Dosing Regimens Of PF-04937319 Compared To An Approved Agent (Sitagliptin) In Patients With Type 2 Diabetes
Official Title  ICMJE A Phase 1b, Randomized, Double-blind, Active Comparator Controlled, 3-period, Cross-over Study To Characterize The Pharmacodynamics And Tolerability Of Two Dosing Regimens Of Pf-04937319 In Adults With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
Brief Summary Study B1621019 will assess efficacy and safety of two different dosing regimens of an investigational agent (PF-04937319) compared to an approved drug (sitagliptin) in patients 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: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: PF-04937319 once-daily
    Tablets, 300 mg once-daily with breakfast, 14-days
  • Drug: PF-04937319 split-dose
    tablets, 150 mg with breakfast plus 100 mg with lunch, 14-days
  • Drug: Sitagliptin once-daily
    tablets, 100 mg once-daily with breakfast, 14-days
Study Arms  ICMJE
  • Experimental: PF-04937319 once-daily
    Intervention: Drug: PF-04937319 once-daily
  • Experimental: PF-04937319 split-dose
    Intervention: Drug: PF-04937319 split-dose
  • Active Comparator: Sitagliptin once-daily
    Intervention: Drug: Sitagliptin once-daily
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: April 1, 2014)		33
Original Estimated Enrollment  ICMJE
 (submitted: August 28, 2013)		30
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with type 2 diabetes, on background metformin therapy either alone or with 1 other oral anti-diabetic agent (excluding Actos)

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 NCT01933672
Other Study ID Numbers  ICMJE B1621019
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 August 2016

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