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A 6-Week Study Of PF-05175157 In Type 2 Diabetes Mellitus

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Profil Institute for Clinical Research, Inc.
Chula Vista, California, 91911 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
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects who have been diagnosed with type 2 diabetes mellitus by a medical
professional according to the American Diabetes Association guidelines.

- Hemoglobin A1c of ≥7 and ≤10.0% in subjects who are metformin-naive or have not taken
metformin for 2 months or Hemoglobin A1c of ≥6.5 and ≤9.5% in subjects who are
metformin-naïve and are taking SU or DPP-IVi which is washed off or taking metformin
and are willing to discontinue metformin in a 8-week washout period.

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

- Evidence or history of clinically significant hematological, renal, endocrine (other
than T2DM and hypothyroidism), gastrointestinal, cardiovascular, pulmonary, hepatic,
psychiatric or neurologic disease.

- A waist circumference which makes fitting imto the bore of the MR scanner impossible.

Subjects with history of dry eye, known ocular or systemic disease that affect the sclera
or cornea.

NCT01792635
Pfizer
Terminated
A 6-Week Study Of PF-05175157 In Type 2 Diabetes Mellitus

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A 6-Week Study Of PF-05175157 In Type 2 Diabetes Mellitus
A 6-week Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel Group Study To Assess Safety, Tolerability And Pharmacodynamics Of Oral Pf-05175157 As Monotherapy In Subjects With Type 2 Diabetes Mellitus
This study is designed to assess the safety, tolerability and pharmacodynamics of 6 weeks of oral doses of PF-05175157 provided as monotherapy in subjects with type 2 diabetes mellitus.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Diabetes Mellitus, Type 2
  • Drug: PF-05175157
    PF-05175157 will be administered at 200 mg twice a day for 43 days.
  • Drug: Placebo
    Placebo tablets matched to PF-05175157 will be administered twice a day for 43 days.
  • No Intervention: Part A (Pilot Study)
  • Experimental: Monotherapy (Part B)
    Interventions:
    • Drug: PF-05175157
    • 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
19
May 2014
May 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who have been diagnosed with type 2 diabetes mellitus by a medical professional according to the American Diabetes Association guidelines.
  • Hemoglobin A1c of ?7 and ?10.0% in subjects who are metformin-naive or have not taken metformin for 2 months or Hemoglobin A1c of ?6.5 and ?9.5% in subjects who are metformin-naïve and are taking SU or DPP-IVi which is washed off or taking metformin and are willing to discontinue metformin in a 8-week washout period.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine (other than T2DM and hypothyroidism), gastrointestinal, cardiovascular, pulmonary, hepatic, psychiatric or neurologic disease.
  • A waist circumference which makes fitting imto the bore of the MR scanner impossible.

Subjects with history of dry eye, known ocular or systemic disease that affect the sclera or cornea.

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
 
 
NCT01792635
B1731003
No
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

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

BY EMAIL

Contact

[email protected]



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