Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

The purpose of this clinical research study is to learn whether saxagliptin (BMS-477118) is more effective than placebo as a treatment for type 2 diabetic subjects who are not sufficiently controlled with diet and exercise

Key facts

Study ID

NCT00121641

Run by

AstraZeneca

People needed

1035

Starts

2005-07-01

Expected to finish

2010-02-01

Last updated by the study team

2015-04-03

Who can join

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

You may qualify if…

• Type 2 diabetes mellitus
• Drug naive
• Hemoglobin (Hb) A1c >= 7.0% and <= 10.0% (>10% and <= 12% for open label arm)
• Fasting C-peptide >= 1 ng/mL
• Body mass index <= 40 kg/m2

You may not qualify if…

• Symptomatic poorly controlled diabetes
• Recent cardiac or cerebrovascular event
• Serum creatinine >= 1.5 mg/dL for males and >= 1.4 mg/dL for Women of Child Bearing Potential

Where it is running

• Local Institution — Birmingham, Alabama, United States
• Local Institution — Calera, Alabama, United States
• Local Institution — Jonesboro, Arizona, United States
• Local Institution — Mesa, Arizona, United States
• Local Institution — Pheonix, Arizona, United States
• Local Institution — Little Rock, Arkansas, United States
• Local Institution — Anaheim, California, United States
• Local Institution — Fountain Valley, California, United States
• Local Institution — Fresno, California, United States
• Local Institution — Long Beach, California, United States
• Local Institution — Los Angeles, California, United States
• Local Institution — Northridge, California, United States
• Local Institution — Rolling Hills Estates, California, United States
• Local Institution — Sacramento, California, United States
• Local Institution — Santa Ana, California, United States
• Local Institution — Spring Valley, California, United States
• Local Institution — Tustin, California, United States
• Local Institution — Castle Rock, Colorado, United States
• Local Institution — Denver, Colorado, United States
• Local Institution — Loveland, Colorado, United States
• Local Institution — Altamonte Springs, Florida, United States
• Local Institution — Chipley, Florida, United States
• Local Institution — Cocoa Beach, Florida, United States
• Local Institution — Coral Gables, Florida, United States
• Local Institution — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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