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