A 6-Week Study Of PF-05175157 In Type 2 Diabetes Mellitus
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 5/5/2014 |
| Start Date: | December 2012 |
| End Date: | November 2014 |
| Contact: | Pfizer CT.gov Call Center |
| Phone: | 1-800-718-1021 |
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.
oral doses of PF-05175157 provided as monotherapy in subjects with type 2 diabetes mellitus.
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.
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