NCT00374907 - A Study Assessing Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise | Biotech Hunter

Enrollment

156

Participants

Timeline

Start Date

September 30, 2006

Primary Completion Date

January 31, 2008

Study Completion Date

December 31, 2009

Conditions

Type 2 Diabetes

Interventions

DRUG

Saxagliptin

Tablet, Oral, 5 mg, Once daily, (up to 12 weeks ST, up to 104 weeks LT)

DRUG

Placebo

Tablet, Oral, 0 mg, Once daily (up to 12 weeks ST)

DRUG

Metformin (blinded)

Tablet, Oral, 500 mg titrated to 1000 mg, Once daily (up to 104 weeks LT, starting at Week 12)

DRUG

Metformin (open-label)

Tablets, Oral, 500-1500 mg, as needed (starting in LT)

Trial Locations (3)

Pennington Biomedical Research Center, Baton Rouge

Diabetes & Glandular Disease Research Assoc,, Inc., San Antonio

Va San Diego Healthcare System, San Diego