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

History of Changes

Tracking Information
First Received Date ^ICMJE	May 8, 2002
Last Updated Date	December 8, 2011
Start Date ^ICMJE	February 2002
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00036192 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea
Official Title ^ICMJE	A Randomized, Double-Blind, Placebo-Controlled Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea
Brief Summary	The purpose of the study is to assess the safety and efficacy of FK614 in type 2 diabetic subjects receiving sulfonylurea (SU) monotherapy.
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Diabetes Mellitus
Intervention ^ICMJE	Drug: FK614
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	200
Completion Date	March 2006
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	25 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00036192
Other Study ID Numbers ^ICMJE	FA-614-0004
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Astellas Pharma Inc
Collaborators ^ICMJE	Astellas Pharma US, Inc.
Investigators ^ICMJE	Not Provided
Information Provided By	Astellas Pharma Inc
Verification Date	December 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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