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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01475461
First received: September 15, 2011
Last updated: April 21, 2014
Last verified: April 2014

September 15, 2011
April 21, 2014
November 2011
January 2013   (final data collection date for primary outcome measure)
HbA1C - change from baseline [ Time Frame: 84-days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01475461 on ClinicalTrials.gov Archive Site
  • Fasting plasma glucose - change from baseline [ Time Frame: 84-days ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 84-days ] [ Designated as safety issue: Yes ]
  • Vitals - systolic blood pressure (SBP), diastolic blood pressue (DBP), heart rate [ Time Frame: 84-days ] [ Designated as safety issue: Yes ]
  • 12-lead electrocardiograms (ECGs) [ Time Frame: 84-days ] [ Designated as safety issue: Yes ]
  • Body weight [ Time Frame: 84-days ] [ Designated as safety issue: Yes ]
  • Clinical laboratory tests - hematology, chemistry, lipid profile, urinalysis [ Time Frame: 84-days ] [ Designated as safety issue: Yes ]
  • Fasting plasma glucose - change from baseline [ Time Frame: 84-days ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 84-days ] [ Designated as safety issue: Yes ]
  • Vitals - systolic blood pressure (SBP), diastolic blood pressue (DBP), heart rate [ Time Frame: 84-days ] [ Designated as safety issue: Yes ]
  • 12-lead electrocardiograms (ECGs) [ Time Frame: 84-days ] [ Designated as safety issue: Yes ]
  • Body weight [ Time Frame: 84-days ] [ Designated as safety issue: Yes ]
  • Clinical laboratory tests - hematology, chemistry, lipid profile, urinalysis [ Time Frame: 84-days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Not Provided

*   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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Hungary,   United States,   Taiwan,   India,   Philippines,   Romania,   Slovakia,   South Africa
 
NCT01475461
B1621007
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2014

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