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Study To Understand Efficacy And Safety Of Investigational Agent (PF-04937319) Compared To Approved Agent (Glimepiride) In Patients With Diabetes On Metformin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01517373
First received: January 20, 2012
Last updated: April 1, 2013
Last verified: April 2013
History of Changes

January 20, 2012
April 1, 2013
February 2012
January 2013   (final data collection date for primary outcome measure)
Change from Baseline over 12-weeks in glycosylated hemoglobin - HbA1C [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01517373 on ClinicalTrials.gov Archive Site
  • Change from Baseline over 12-weeks in fasting plasma glucose [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Proportion of Subjects achieving HbA1C <6.5% and <7% at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline over 12-weeks in fasting plasma glucose [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Proportion of Subjects acheiving HbA1C <6.5% and <7% at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study To Understand Efficacy And Safety Of Investigational Agent (PF-04937319) Compared To Approved Agent (Glimepiride) In Patients With Diabetes On Metformin
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Study To Evaluate Safety And Efficacy Of PF-04937319 And Glimepiride In Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin

This is a study to understand efficacy and safety of investigational agent (PF-04937319) compared to approved agent (glimepiride) in patients with diabetes on metformin
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
Diabetes Mellitus, Type 2
  • Drug: Placebo
    Combination of tablets and capsules, a total of 3 pills/dose, administered once daily for 84-days
  • Drug: PF-04937319 10 mg
    Combination of tablets and capsules, dose of 10 mg, a total of 3 pills/dose, administered once daily for 84-days
  • Drug: PF-04937319 50 mg
    Combination of tablets and capsules, dose of 50 mg, a total of 3 pills/dose, administered once daily for 84-days
  • Drug: PF-04937319 100 mg
    Combination of tablets and capsules, dose of 100 mg, a total of 3 pills/dose, administered once daily for 84-days
  • Drug: Glimepiride
    Combination of tablets and capsules, dose of up to 6 mg, a total of 3 pills/dose, administered once daily for 84-days
  • Placebo Comparator: Placebo
    Placebo to match PF-04937319 and glimepiride
    Intervention: Drug: Placebo
  • Experimental: PF-04937319 10 mg
    Intervention: Drug: PF-04937319 10 mg
  • Experimental: PF-04937319 50 mg
    Intervention: Drug: PF-04937319 50 mg
  • Experimental: PF-04937319 100 mg
    Intervention: Drug: PF-04937319 100 mg
  • Active Comparator: Glimepiride
    Intervention: Drug: Glimepiride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
305
January 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18-70 yrs, male and females, with T2DM, on metformin alone or in combination with 1 other oral agent

Exclusion Criteria:

  • Subjects with recent cardiovascular events, those with evidence of diabetic complications
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Bulgaria,   Canada,   Hungary,   India,   Slovakia,   Taiwan
 
NCT01517373
B1621002
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2013

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