Skip to main content
OpenTrials
Completed

NCT Number: NCT00036192

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

International Institute of Clinical Research, Inc., Ozark, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FK614

Drug

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Astellas Pharma US, Inc.

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea

Important dates

Study start
2002
Study completion
2006
First posted
May 9, 2002
Registry last updated
Dec 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.