forREAL: FORXIGA PRESCRIPTION EVENT MONITORING PROGRAM (PEMP) - forREAL
Study identifier:MB102-209
ClinicalTrials.gov identifier:NCT01944618
EudraCT identifier:N/A
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
forREAL: FORXIGA (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE) PRESCRIPTION EVENT MONITORING PROGRAM
Medical condition
Type 2 Diabetes
Phase
-
Healthy volunteers
No
Study drug
Forxiga
Sex
All
Actual Enrollment
5000
Study type
Observational
Age
18 Years - 75 Years
Date
Study Start Date: 01 Oct 2013
Primary Completion Date: 01 Oct 2015
Study Completion Date: 01 Oct 2015
Study design
Allocation: -
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verification:
Verified 01 Sept 2016 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
Monash University
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| T2DM patients newly prescribed Forxiga A post-marketing evaluation of the safety of Forxiga (10 mg tablets, orally once daily for 6 months) through an observational prescription adverse event monitoring program (registry-based monitoring program) is warranted to assess real-world incidence of adverse events in routine clinical practice. | Drug: Forxiga FORXIGA is a prescription medicine used with diet, exercise and sometimes other medicines (which may include metformin; insulin; a sulfonylurea medicine such as gliclazide, glimepiride and glibenclamide; or a dipeptidyl peptidase-4 inhibitor [DPP 4 inhibitor] such as sitagliptin or saxagliptin) to control the levels of blood sugar (glucose) in patients with type 2 diabetes mellitus. Other Name: Dapagliflozin |
Contacts
Investigators
Principal Investigator
Sophia Zoungas
Monash University
