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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

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Sierra Clinical Research
Roseville, California, 95661 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
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

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

- Subjects with recent cardiovascular events, those with evidence of diabetic
complications

NCT01517373
Pfizer
Completed
Study To Understand Efficacy And Safety Of Investigational Agent (PF-04937319) Compared To Approved Agent (Glimepiride) In Patients With Diabetes On Metformin

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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
A Phase 2, Randomized, Double-blinded, 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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
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
304
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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Canada,   Hungary,   India,   Slovakia,   Taiwan,   United States
 
 
NCT01517373
B1621002
2011-005206-30 ( 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

FOR MORE INFORMATION

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