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A 6-Week Study To Determine The Safety And Effect Of An Investigational Drug Given With Canagliflozin In Adults With Type 2 Diabetes Mellitus Taking Metformin

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NCT02053116

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
DeLand, Florida, 32720 United States
See other locations
Contact
1-800-718-1021
[email protected]m
Related Links
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
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients with Type 2 Diabetes Mellitus and treated with metformin at a dose greater
than or equal to 1000 mg for at least 3 months and are willing to switch to
canagliflozin from metformin for the duration of the study

- Hemoglobin A1c of 7-10% at screening.

- Body Mass Index of at least 25 kg/m2.

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

- Compliant with study drug administration during the run-in period and throughout the
trial.

- Patients with fasting triglycerides greater than 500 mg/dL at screening.

- History of certain diabetic complications or cardiac problems.

NCT02053116
Pfizer
Terminated
A 6-Week Study To Determine The Safety And Effect Of An Investigational Drug Given With Canagliflozin In Adults With Type 2 Diabetes Mellitus Taking Metformin

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A 6-Week Study To Determine The Safety And Effect Of An Investigational Drug Given With Canagliflozin In Adults With Type 2 Diabetes Mellitus Taking Metformin
A 6-week Phase 2a Randomized, Double-Blind, Placebo-Controlled Study To Assess Safety, Tolerability And Pharmacodynamics Of Oral PF-05175157 Administered With Canagliflozin In Adult Subjects With Type 2 Diabetes Mellitus
A Phase 2a study to evaluate the effects of an investigational compound administered at 200 mg, twice daily (BID), for 6 weeks, with canagliflozin, in adult subjects with Type 2 Diabetes Mellitus (T2DM).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Type 2 Diabetes Mellitus
  • Drug: PF-05175157
    Tablet, 200 mg, twice daily, 6 weeks
  • Drug: Placebo
    Tablet, 0 mg, twice daily, 2 weeks
  • Experimental: PF-05175157
    Intervention: Drug: PF-05175157
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
April 2014
April 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with Type 2 Diabetes Mellitus and treated with metformin at a dose greater than or equal to 1000 mg for at least 3 months and are willing to switch to canagliflozin from metformin for the duration of the study
  • Hemoglobin A1c of 7-10% at screening.
  • Body Mass Index of at least 25 kg/m2.

Exclusion Criteria:

  • Compliant with study drug administration during the run-in period and throughout the trial.
  • Patients with fasting triglycerides greater than 500 mg/dL at screening.
  • History of certain diabetic complications or cardiac problems.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02053116
B1731006
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2014

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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