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

This study has been completed.

First Received: May 8, 2002 Last Updated: July 28, 2008 History of Changes

Sponsors and Collaborators:	Astellas Pharma Inc Astellas Pharma US, Inc.
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00036192

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Diabetes

Drug Information available for: FK 614

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Estimated Enrollment:	200
Study Start Date:	February 2002

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

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

Study ID Numbers:	FA-614-0004
Study First Received:	May 8, 2002
Last Updated:	July 28, 2008
ClinicalTrials.gov Identifier:	NCT00036192 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on July 02, 2009