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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00036192
First received: May 8, 2002
Last updated: December 8, 2011
Last verified: December 2011
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus
Drug: FK614
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Estimated Enrollment: 200
Study Start Date: February 2002
Study Completion Date: March 2006
Detailed 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.

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036192

  Show 36 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma US, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00036192     History of Changes
Other Study ID Numbers: FA-614-0004
Study First Received: May 8, 2002
Last Updated: December 8, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 21, 2014