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

NCT01792635

Last updated date
Study Location
Profil Institute for Clinical Research, Inc.
Chula Vista, California, 91911, United States
Contact
1-800-718-1021

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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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A 6-Week Study Of PF-05175157 In Type 2 Diabetes Mellitus
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • No Intervention: Part A (Pilot Study)
  • Experimental: Monotherapy (Part B)
    Interventions:
    • Drug: PF-05175157
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 22, 2016)
19
Original Estimated Enrollment  ICMJE
 (submitted: February 13, 2013)
66
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01792635
Other Study ID Numbers  ICMJE B1731003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2016

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