A Study Assessing Saxagliptin Treatment in Type 2 Diabetic Subjects Who Are Not Controlled With TZD Therapy 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 thiazolidinedione (TZD) therapy is more effective than TZD alone as a treatment for Type 2 diabetic subjects who are not sufficiently controlled with TZD alone

Key facts

Study ID

NCT00295633

Run by

AstraZeneca

People needed

565

Starts

2006-03-01

Expected to finish

2008-10-01

Last updated by the study team

2015-04-07

Who can join

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

You may qualify if…

• Type 2 diabetics currently receiving a stable dose of TZD monotherapy (pioglitazone 30mg or 45mg, or rosiglitazone 4mg or 8mg) for at least 12 weeks prior to screening.
• Hemoglobin A1c (HbA1c) > = 7.0% and < = 10.5%
• Body mass index < = 45kg/m2
• Fasting C-peptide > = 1 ng/mL

You may not qualify if…

• Symptomatic poorly controlled diabetes
• Recent cardiac or cerebrovascular event
• Serum creatinine > = 2.0 mg/dL

Where it is running

• Sunbelt Research Group, Llc — Mobile, Alabama, United States
• Iicr, Inc. — Ozark, Alabama, United States
• Clinical Research Advantage, Inc — Mesa, Arizona, United States
• Nea Clinic — Jonesboro, Arkansas, United States
• Little Rock Family Practice Clinic — Little Rock, Arkansas, United States
• Impact Clinical Trials — Beverly Hills, California, United States
• Lovelace Scientific Resources, Inc. — Beverly Hills, California, United States
• Medical Group Of Encino — Encino, California, United States
• Marin Endocrine Care And Research, Inc. — Greenbrae, California, United States
• Del Rosario Medical Clinic, Inc. — Huntington Park, California, United States
• Loma Linda Va Healthcare Systems — Loma Linda, California, United States
• Peak Health Medical Group — Los Angeles, California, United States
• Richard Cherlin, Md — Los Gatos, California, United States
• Mission Internal Medical Group — Mission Viejo, California, United States
• Desert Medical Advances — Palm Desert, California, United States
• Denver Internal Medicine Group — Denver, Colorado, United States
• Stamford Therapeutics Consortium — Stamford, Connecticut, United States
• Phoenix Internal Medicine Associates, Llc — Waterbury, Connecticut, United States
• Central Florida Clinical Trials, Inc. — Altamonte Springs, Florida, United States
• Southern Family Healthcare, Pa — Chipley, Florida, United States
• Doctors Medical Center Of Walton County — DeFuniak Springs, Florida, United States
• Horizon Institute For Clinical Research — Hollywood, Florida, United States
• Jacksonville Center For Clinical Research — Jacksonville, Florida, United States
• Panhandle Family Care Associates — Marianna, Florida, United States
• Winston Technology, Inc. — Haleyville, Alabama, United States

Full record on ClinicalTrials.gov

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