Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Astellas Pharma Inc
With
Astellas Pharma US, Inc.
This is a prospective randomized, double-blind, placebo controlled, parallel group, Phase 2 study. Subjects meeting selection criteria will be randomly assigned to receive 12 weeks twice daily (BID) dosing with FK614 or placebo. Enrollment for this study will be approximately 200 patients.
Age
25–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Has history of type 2 diabetes mellitus for at least 1 year
Has been taking current sulfonylurea (SU) for at least 3 months. Subjects currently taking metformin may be eligible to be switched.
Has not received any oral antidiabetic medication other than an SU or taken regularly prescribed insulin for at least 3 months
You may not be if
Has type 1 diabetes mellitus
Has uncontrolled hypertension, i.e., systolic BP \>170 or diastolic BP \> 95 mm Hg.
History of congestive heart failure
Clareo Health | Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea