Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea
Status and phase
Completed
Phase 2
Conditions
Diabetes Mellitus
Treatments
Drug: FK614
Details and patient eligibility
About
The purpose of the study is to assess the safety and efficacy of FK614 in type 2 diabetic subjects receiving sulfonylurea (SU) monotherapy.
Full description
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.
Sex
All
Ages
25 to 70 years old
Volunteers
No Healthy Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Has type 1 diabetes mellitus
- Has uncontrolled hypertension, i.e., systolic BP >170 or diastolic BP > 95 mm Hg.
- History of congestive heart failure
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
Trial contacts and locations
36
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Data sourced from clinicaltrials.gov
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