Status:
COMPLETED
A Study Assessing Saxagliptin Treatment in Type 2 Diabetic Subjects Who Are Not Controlled With TZD Therapy Alone
Lead Sponsor:
AstraZeneca
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-77 years
Phase:
PHASE3
Brief Summary
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 ar...
Detailed Description
All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Symptomatic poorly controlled diabetes
- Recent cardiac or cerebrovascular event
- Serum creatinine \> = 2.0 mg/dL
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
565 Patients enrolled
Trial Details
Trial ID
NCT00295633
Start Date
March 1 2006
End Date
October 1 2008
Last Update
April 7 2015
Active Locations (133)
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1
Winston Technology, Inc.
Haleyville, Alabama, United States, 35565
2
Sunbelt Research Group, Llc
Mobile, Alabama, United States, 36606
3
Iicr, Inc.
Ozark, Alabama, United States, 36360
4
Clinical Research Advantage, Inc
Mesa, Arizona, United States, 85213