Safety and Efficacy Study of Subjects That Are Taking Saxagliptin Added Onto Metformin XR Compared to Subjects Taking Metformin XR Alone

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

This protocol will compare 24 hour glucose control for subject taking saxagliptin and metformin extended release (XR) versus metformin XR alone

Key facts

Study ID

NCT00683657

Run by

AstraZeneca

People needed

93

Starts

2008-07-01

Expected to finish

2009-02-01

Last updated by the study team

2015-06-01

Who can join

Age: 18 and older, up to 77. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥18- and ≤77-years-old
• Type 2 diabetes
• Taking metformin immediate release (IR) or XR ≥1500 mg for at least 8 weeks as monotherapy
• Glycosylated hemoglobin (A1C) ≥7% and ≤10%
• Body mass index (BMI) ≤40 kg/m2

You may not qualify if…

• Women of childbearing potential unable or unwilling to use acceptable birth control
• Women who are pregnant or breastfeeding
• Significant cardiovascular history
• Active liver disease
• Renal impairment

Where it is running

• Dedicated Phase I, Inc. — Phoenix, Arizona, United States
• Amcr Institute, Inc — Escondido, California, United States
• Irvine Center For Clinical Research, Inc. — Irvine, California, United States
• Pacific Sleep Medicine Services (Avastra Clinical Trials) — Redlands, California, United States
• Advantage Clinical Research — Santa Ana, California, United States
• Orange County Research Center — Tustin, California, United States
• River Birch Research Alliance, Llc — Blue Ridge, Georgia, United States
• Endocrine Research Solutions, Inc. — Roswell, Georgia, United States
• Jasper Clinic, Inc. — Kalamazoo, Michigan, United States
• Clinilabs, Inc. — New York, New York, United States
• Covance Cru, Inc. — Portland, Oregon, United States
• Dgd Research, Inc. — San Antonio, Texas, United States
• Avastra Clinical Trials — Midvale, Utah, United States
• Local Institution — Martínez, Buenos Aires, Argentina
• Local Institution — Holon, Israel
• Local Institution — Jerusalem, Israel
• Local Institution — Kfar Saba, Israel
• Local Institution — Ẕerifin, Israel
• Local Institution — Milan, Italy
• Local Institution — Aguascalientes, Aguascalientes, Mexico
• Local Institution — Monterrey, Nuevo León, Mexico
• Local Institution — Cebu City, Philippines
• Local Institution — Marikina City, Philippines
• Local Institution — Ponce, Puerto Rico, Puerto Rico
• Local Institution — Lund, Sweden, Sweden

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.