Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to assess the safety and efficacy of FK614 in type 2 diabetic subjects receiving sulfonylurea (SU) monotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: Astellas Pharma US, Inc.

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