Add-on to Thiazolidinedione (TZD) Failures

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well controlled on TZD alone. The safety of this treatment will also be studied

Key facts

Study ID

NCT00683878

Run by

AstraZeneca

People needed

972

Starts

2008-07-01

Expected to finish

2010-06-01

Last updated by the study team

2017-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females, ≥ 18 years old, with type 2 diabetes and with inadequate glycemic control
• All subjects must have central laboratory pre-randomization A1C ≥ 7.0 and ≤ 10.5%
• C-peptide ≥ 1.0 ng/mL (0.34 nmol/L)
• Body Mass Index ≤ 45.0 kg/m²

You may not qualify if…

• AST and /or ALT > 2.5 times the upper limit of normal
• Serum total bilirubin > 2 mg/dL (34.2 µmol/L)
• Creatinine kinase > 3.0 times the upper limit of normal
• Symptoms of severely uncontrolled diabetes
• Serum creatinine ≥ 2.0 mg/dL
• Calculated Cr-Clearance < 50 ml/min (calculated by Cockroft-Gault formula)
• Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases

Where it is running

• Iicr — Ozark, Alabama, United States
• 43rd Medical Associates, P.C. — Phoenix, Arizona, United States
• Clinical Research Advantage Inc / Desert Clinical Res, Llc — Tempe, Arizona, United States
• Clinical Research Advantage, Inc — Tempe, Arizona, United States
• Little Rock Family Practice Clinic — Little Rock, Arkansas, United States
• Searcy Medical Center — Searcy, Arkansas, United States
• Clinical Innovations, Inc. — Costa Mesa, California, United States
• Marin Endocrine Care And Research, Inc. — Greenbrae, California, United States
• Torrance Clinical Research — Lomita, California, United States
• Randall Shue, D.O. — Los Angeles, California, United States
• Diabetes Medical Center Of California — Northridge, California, United States
• Desert Medical Advances — Palm Desert, California, United States
• Avastra Clinical Trials — Redlands, California, United States
• Sierra Clinical Research — Roseville, California, United States
• Ritchken & First M.D.'S — San Diego, California, United States
• Advantage Clinical Research — Santa Ana, California, United States
• Encompass Clinical Research — Spring Valley, California, United States
• Diabetes Research Center — Tustin, California, United States
• Aurora Family Medicine Center, P.C. — Aurora, Colorado, United States
• Denver Internal Medicine — Denver, Colorado, United States
• Central Florida Clinical Trials — Altamonte Springs, Florida, United States
• Health First Clinical Research Group, Inc. — Chipley, Florida, United States
• Clinical Therapeutics Corporation — Coral Gables, Florida, United States
• Westside Center For Clinical Research — Jacksonville, Florida, United States
• Pinnacle Research Group, Llc — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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