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

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Anaheim Clinical Trials
Anaheim, California, 92801 United States
Contact
1-800-718-1021
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

NCT01475461
Pfizer
Completed
Phase 2 Study To Evaluate Safety And Efficacy Of Investigational Drug - PF04937319 In Patients With Type 2 Diabetes

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Phase 2 Study To Evaluate Safety And Efficacy Of Investigational Drug - PF04937319 In Patients With Type 2 Diabetes
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
B1621007 is designed to study the safety and efficacy of PF-04937319 in patients with type 2 diabetes
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • 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
  • 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
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.
 
Completed
345
January 2013
January 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Hungary,   India,   Philippines,   Romania,   Slovakia,   South Africa,   Taiwan,   United States
 
 
NCT01475461
B1621007
2011-004002-25 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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