Status:
COMPLETED
Add-on to Thiazolidinedione (TZD) Failures
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Astra Zeneca, Bristol-Myers Squibb
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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. ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
972 Patients enrolled
Trial Details
Trial ID
NCT00683878
Start Date
July 1 2008
End Date
June 1 2010
Last Update
February 23 2017
Active Locations (89)
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1
Pinnacle Research Group, Llc
Anniston, Alabama, United States, 36207
2
Iicr
Ozark, Alabama, United States, 36360
3
43rd Medical Associates, P.C.
Phoenix, Arizona, United States, 85051
4
Clinical Research Advantage Inc / Desert Clinical Res, Llc
Tempe, Arizona, United States, 85282