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Dapagliflozin DPPIV inhibitor add-on study
Study identifier:D1690C00010
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, International Phase III Study with 24 week Extension to Evaluate the Safety and Efficacy of Dapagliflozin 10 mg/Day in patients with Type 2 Diabetes who have Inadequate Glycemic Control on a DPP-4 inhibitor Sitagliptin+/-Metformin
Medical condition
Type 2 Diabetes
Phase
Phase 3
Healthy volunteers
No
Study drug
Dapagliflozin, Placebo
Sex
All
Actual Enrollment
833
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Oct 2009
Primary Completion Date: 01 Mar 2011
Study Completion Date: 01 Sept 2011
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Jun 2014 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Bristol Myers Squibb
Inclusion and exclusion criteria
Location
Research Site
BERAZATEGUI, Buenos Aires, Argentina
Location
Research Site
BUENOS AIRES, CABA, Argentina
Location
Research Site
CABA, CABA, Argentina
Location
Research Site
CORDOBA, Cordoba, Argentina
Location
Research Site
LA PLATA, Buenos Aires, Argentina
Location
Research Site
LANUS, Buenos Aires, Argentina
Location
Research Site
MAR DEL PLATA, Buenos Aires, Argentina
Location
Research Site
MORON, Buenos Aires, Argentina
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 Dapagliflozin 10 mg tablet | Drug: Dapagliflozin 10 mg tablet, oral, once daily, 48 weeks |
| Placebo Comparator: 2 Matching placebo tablet | Drug: Placebo Matching placebo tablet |
Contacts
Investigators
Principal Investigator
Serge Jabbour
Thomas Jefferson University, Philadelphia
