Study Assessing Saxagliptin Treatment In Type 2 Diabetic Subjects Who Are Not Controlled With Metformin Alone

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 added to Metformin therapy is more effective than Metformin alone as a treatment for type 2 diabetic subjects who are not sufficiently controlled with Metformin alone

Key facts

Study ID

NCT00121667

Run by

AstraZeneca

People needed

1462

Starts

2005-08-01

Expected to finish

2010-02-01

Last updated by the study team

2015-04-29

Who can join

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

You may qualify if…

• Type 2 diabetes mellitus requiring treatment with at least 1500 mg but not greater than 2550 mg of a maximum tolerated dose of Metformin therapy for at least 8 weeks prior to screening.
• HbA1c >= 7.0% and <= 10.0 %
• Body mass index <= 40 kg/m2
• Fasting C-peptide >= 1 ng/dL

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 females

Where it is running

• Local Institution — Birmingham, Alabama, United States
• Local Institution — Calera, Alabama, United States
• Local Institution — Haleyville, Alabama, United States
• Local Institution — Mesa, Arizona, United States
• Local Institution — Phoenix, Arizona, United States
• Local Institution — Jonesboro, Arkansas, United States
• Local Institution — Little Rock, Arkansas, United States
• Local Institution — Sherwood, Arkansas, United States
• Local Institution — Encino, California, United States
• Local Institution — Fountain Valley, California, United States
• Local Institution — Fresno, California, United States
• Local Institution — Los Angeles, California, United States
• Local Institution — Mission Viejo, California, United States
• Local Institution — Northridge, California, United States
• Local Institution — Orange, California, United States
• Local Institution — Roseville, California, United States
• Local Institution — Sacramento, 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 — Colorado Springs, Colorado, United States
• Local Institution — Denver, Colorado, United States
• Local Institution — Golden, Colorado, United States
• Local Institution — Loveland, Colorado, United States
• Local Institution — Anniston, Alabama, United States

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.