The purpose of this study is to gain safety and efficacy information in patients with type 2 diabetes, who have not previously taken any oral antidiabetic medications, and who have an HbA1c value of greater than or equal to 10%, despite diet and exercise.

Condition	Treatment or Intervention	Phase
type 2 diabetes	Drug: marketed drug for type 2 diabetes	Phase IV

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion criteria:

• male or female patients with type 2 diabetes
• aged between 18-70 years
• drug-naive
• Laboratory test result for HbA1c of greater than or equal to 10%
• written informed consent

Exclusion criteria:

• prior use of antidiabetic medications within 3 months of screening
• fluid retention (edema)
• significant liver disease
• low red blood cells (anemia)
• severe or unstable angina (chest pain)
• congestive heart failure
• severe high blood pressure
• alcohol or drug abuse
• other inclusion or exclusion criteria to be determined by the physician and study sponsor.

Arizona
      Tucson,  Arizona,  85712,  United States
      Tucson,  Arizona,  85745,  United States
      Mesa,  Arizona,  85201,  United States
      Phoenix,  Arizona,  85014,  United States
California
      Rolling Hills Est,  California,  90274,  United States
      Kenner,  California,  70062,  United States
      Fair Oaks,  California,  70062,  United States
Florida
      Tampa,  Florida,  33614,  United States
Illinois
      Chicago,  Illinois,  60622,  United States
Kansas
      Overland Park,  Kansas,  66210,  United States
Kentucky
      Lebanon,  Kentucky,  40033,  United States
Maine
      Bangor,  Maine,  04401,  United States
Minnesota
      Minneapolis,  Minnesota,  55417,  United States
      Minneapolis,  Minnesota,  55407,  United States
Nevada
      Las Vegas,  Nevada,  89103,  United States
New Jersey
      Bloomfield,  New Jersey,  07003,  United States
Ohio
      Youngstown,  Ohio,  44505,  United States
Oregon
      Medford,  Oregon,  97504,  United States
      Medford,  Oregon,  97504,  United States
Pennsylvania
      Downingtown,  Pennsylvania,  19335,  United States
      Sellersville,  Pennsylvania,  18960,  United States
      Pittsburgh,  Pennsylvania,  15243,  United States
      Philadelphia,  Pennsylvania,  19107,  United States
      Allentown,  Pennsylvania,  18102,  United States
      Steelton,  Pennsylvania,  17113,  United States
      Reading,  Pennsylvania,  10601,  United States
      Beaver,  Pennsylvania,  15009,  United States
      Feasterville,  Pennsylvania,  19053,  United States
      Philadelphia,  Pennsylvania,  19152,  United States
Rhode Island
      East Providence,  Rhode Island,  02914,  United States
South Carolina
      Mt. Pleasant,  South Carolina,  29464,  United States
Tennessee
      Murfreesboro,  Tennessee,  37130,  United States
Texas
      Midland,  Texas,  79705,  United States
      Georgetown,  Texas,  78626,  United States
      San Antonio,  Texas,  78221,  United States
      Dallas,  Texas,  75230,  United States
      San Antonio,  Texas,  78229,  United States
      Dallas,  Texas,  75390,  United States
Vermont
      Virginia Beach,  Vermont,  23455,  United States
Virginia
      Norfolk,  Virginia,  23502,  United States

Study ID Numbers:  49653/326
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  August 29, 2002
ClinicalTrials.gov Identifier:  NCT00044460
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08