Status:
COMPLETED
Evaluation of Dapagliflozin Taken Twice-daily
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-77 years
Phase:
PHASE3
Brief Summary
This study is being carried out to see if dapagliflozin - administered in a daily dose of 2.5 mg given twice a day or 5 mg twice a day or 10mg once daily - in addition to metformin, is beneficial in d...
Eligibility Criteria
Inclusion
- Provision of informed consent prior to any study specific procedures
- Diagnosis of T2DM
- Current antihyperglycaemic treatment with metformin immediate release formulation monotherapy \>/= 1500 mg/day at a stable dose for at least 10 weeks prior to enrolment. Other treatment with OADs within the 10 weeks prior to enrolment is not permitted.
- HbA1c ≥ 6.7% and ≤10.5%, based on central laboratory values from Screening Visit, and Enrolment Visit 1.
Exclusion
- Diagnosis of Type 1 diabetes mellitus, known diagnosis of Maturity Onset Diabetes of the Young (MODY) or secondary causes of diabetes mellitus
- History of diabetic ketoacidosis
- Symptoms of poorly controlled diabetes including, but not limited to, marked polyuria, polydipsia, and/or greater than 10% weight loss during the 3 months prior to enrolment
- FPG \>270 mg/dL (\>15.0 mmol/L)
- BMI \>45 kg/m2
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT01217892
Start Date
November 1 2010
End Date
August 1 2011
Last Update
October 27 2014
Active Locations (55)
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1
Research Site
Aßlar, Germany
2
Research Site
Berlin, Germany
3
Research Site
Biberach A.d. Riss, Germany
4
Research Site
Bosenheim, Germany