Status:

TERMINATED

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

Lead Sponsor:

Pfizer

Conditions:

Diabetes Mellitus, Type 2

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

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.

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

December 1 2012

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2014

Estimated Enrollment :

19 Patients enrolled

Trial Details

Trial ID

NCT01792635

Start Date

December 1 2012

End Date

May 1 2014

Last Update

February 16 2017

Active Locations (1)

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1

Profil Institute for Clinical Research, Inc.

Chula Vista, California, United States, 91911