A Study To Evaluate The Safety And Efficacy Of An Investigational Diabetes Drug In Poorly Controlled Type II Diabetics

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

The purpose of this research study is to determine if a new investigational diabetes drug is safe and effective in treating people who have Type II diabetes mellitus with very high HbA1c or FPG (fasting plasma glucose) levels. The HbA1c test, also called the hemoglobin A1c test or glycated hemoglobin test, is a measurement of the average amount of sugar in the blood over the last 2 to 3 months. FPG is a test that measures the amount of sugar in the blood after an 8 hour fast.

Key facts

Study ID

NCT00067951

Run by

GlaxoSmithKline

People needed

190

Starts

2003-10-17

Expected to finish

2004-11-30

Last updated by the study team

2018-03-21

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Laboratory result for HbA1c >11% or FPG >270mg/dL
• Clinical diagnosis of Type II diabetes
• Prior treatment with diet and/or exercise alone, or less than 15 days of prior treatment with an oral anti-diabetic medication or insulin.

You may not qualify if…

• Women who are pregnant

Where it is running

• GSK Investigational Site — Chandler, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Tucson, Arizona, United States
• GSK Investigational Site — Encinitas, California, United States
• GSK Investigational Site — Fullerton, California, United States
• GSK Investigational Site — Los Banos, California, United States
• GSK Investigational Site — Mission Viejo, California, United States
• GSK Investigational Site — Jacksonville, Florida, United States
• GSK Investigational Site — Melbourne, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Saint Cloud, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Fayetteville, Georgia, United States
• GSK Investigational Site — Woodstock, Georgia, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Evansville, Indiana, United States
• GSK Investigational Site — Newburgh, Indiana, United States
• GSK Investigational Site — Slidell, Louisiana, United States
• GSK Investigational Site — Jackson, Mississippi, United States
• GSK Investigational Site — Chesterfield, Missouri, United States
• GSK Investigational Site — Kansas City, Missouri, United States
• GSK Investigational Site — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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