Status:
COMPLETED
Efficacy and Safety of Dapagliflozin, Added to Therapy of Patients With Type 2 Diabetes With Inadequate Glycemic Control on Insulin
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This study is being carried out to see if Dapagliflozin in addition to insulin is effective and safe in treating patients with type 2 diabetes when compared to placebo (identical looking inactive trea...
Eligibility Criteria
Inclusion
- Type 2 Diabetes
- Patients with HbA1c ≥7.5% and ≤10.5% and who are on a stable insulin regimen of at least 30 IU of injectable insulin per day either without any other oral antidiabetic drug or with a stable dose of oral antidiabetic drugs
Exclusion
- Type 1 Diabetes
- Treatment with more than two additional oral antidiabetic drugs
- Moderate and severe renal (kidney) failure or dysfunction
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
1240 Patients enrolled
Trial Details
Trial ID
NCT00673231
Start Date
April 1 2008
End Date
January 1 2011
Last Update
October 29 2013
Active Locations (92)
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1
Research Site
Fresno, California, United States
2
Research Site
Greenbrae, California, United States
3
Research Site
Roswell, Georgia, United States
4
Research Site
Chicago, Illinois, United States