Status:
COMPLETED
Evaluation of the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type 2 Diabetes
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
30-75 years
Phase:
PHASE3
Brief Summary
This study is being carried out to see if dapagliflozin in addition to metformin decreases body weight and if so, how it compares with metformin alone.
Eligibility Criteria
Inclusion
- Type 2 diabetes
- Ongoing treatment with metformin on a stable dose of ≥1500 mg/day for at least 12 weeks prior to enrolment
- Inadequate glycemic control, defined as HbA1c ≥6.5% and ≤8.5%
- ≥30 years for males
- ≥55 years for females
Exclusion
- Type 1 Diabetes
- Body weight change \>5% within 3 months prior to enrolment
- Renal and liver impairment
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT00855166
Start Date
February 1 2009
End Date
December 1 2011
Last Update
October 14 2013
Active Locations (21)
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1
Research Site
Blagoevgrad, Bulgaria
2
Research Site
Sofia, Bulgaria
3
Research Site
Beroun, Czechia
4
Research Site
Brno, Czechia