Phase 2 Study To Evaluate Safety And Efficacy Of Investigational Drug - PF04937319 In Patients With Type 2 Diabetes

NCT01475461

Last updated date
Study Location
Anaheim Clinical Trials
Anaheim, California, 92801, 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
18-55 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 metformin, age between 18-55 yrs, male or female

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


- patients with type 1 diabetes, medically unstable, unacceptable clinical laboratory
test results at screening

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Advanced Information
Descriptive Information
Brief Title  ICMJE Phase 2 Study To Evaluate Safety And Efficacy Of Investigational Drug - PF04937319 In Patients With Type 2 Diabetes
Official Title  ICMJE A Phase 2, Randomized, Double-blinded, Placebo-controlled, Dose-ranging, Parallel Group Study To Evaluate Safety And Efficacy Of Pf-04937319 And Sitagliptin On Glycemic Control In Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
Brief Summary B1621007 is designed to study the safety and efficacy of PF-04937319 in patients with type 2 diabetes
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Placebo
    double-dummy placebo tablets administered once-daily for 84-days
  • Drug: PF-04937319 - 3mg
    PF-04937319 3mg administered as tablets once-daily for 84-days
  • Drug: PF-04937319 - 20mg
    PF-04937319 20mg administered as tablets once-daily for 84-days
  • Drug: PF-04937319 - 50mg
    PF-04937319 50mg administered as tablets once-daily for 84-days
  • Drug: PF-04937319 - 100mg
    PF-04937319 100mg administered as tablets once-daily for 84-days
  • Drug: Sitagliptin - 100mg
    Sitagliptin 100mg administered as tablets once-daily for 84-days
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: PF-04937319 - Dose 1
    Intervention: Drug: PF-04937319 - 3mg
  • Experimental: PF-04937319 - Dose 2
    Intervention: Drug: PF-04937319 - 20mg
  • Experimental: PF-04937319 - Dose 3
    Intervention: Drug: PF-04937319 - 50mg
  • Experimental: PF-04937319 - Dose 4
    Intervention: Drug: PF-04937319 - 100mg
  • Active Comparator: Sitagliptin
    Intervention: Drug: Sitagliptin - 100mg
Publications * Amin NB, Aggarwal N, Pall D, Paragh G, Denney WS, Le V, Riggs M, Calle RA. Two dose-ranging studies with PF-04937319, a systemic partial activator of glucokinase, as add-on therapy to metformin in adults with type 2 diabetes. Diabetes Obes Metab. 2015 Aug;17(8):751-9. doi: 10.1111/dom.12474. Epub 2015 May 11.

*   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: February 20, 2013)
345
Original Estimated Enrollment  ICMJE
 (submitted: November 16, 2011)
300
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients with type 2 diabetes, on metformin, age between 18-55 yrs, male or female

Exclusion Criteria:

  • patients with type 1 diabetes, medically unstable, unacceptable clinical laboratory test results at screening
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary,   India,   Philippines,   Romania,   Slovakia,   South Africa,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01475461
Other Study ID Numbers  ICMJE B1621007
2011-004002-25 ( EudraCT Number )
Has Data Monitoring Committee Yes
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 December 2016

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