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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01944618




Registration number
NCT01944618
Ethics application status
Date submitted
13/09/2013
Date registered
17/09/2013
Date last updated
13/09/2016

Titles & IDs
Public title
forREAL: FORXIGA PRESCRIPTION EVENT MONITORING PROGRAM (PEMP)
Scientific title
forREAL: FORXIGA (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE) PRESCRIPTION EVENT MONITORING PROGRAM
Secondary ID [1] 0 0
MB102-209
Universal Trial Number (UTN)
Trial acronym
forREAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Forxiga

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.


Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence rates of adverse events, specifically genital infections, urinary tract infections, increased haematocrit, renal impairment, hepatic impairment, bone fractures and cancers, in particular breast, bladder, and prostate cancers
Timepoint [1] 0 0
Up to 6 months
Primary outcome [2] 0 0
Any early adverse effects as a result of drug interactions in patients with Type 2 diabetes who are treated with Forxiga in routine Australian clinical practice
Timepoint [2] 0 0
Up to 6 months
Primary outcome [3] 0 0
Incidence rates of spontaneously reported hypoglycaemia in patients with Type 2 diabetes who are treated with Forxiga in routine Australian clinical practice
Timepoint [3] 0 0
Up to 6 months
Secondary outcome [1] 0 0
Rate of prescribing of Forxiga after its introduction to routine Australian clinical practice
Timepoint [1] 0 0
Upto 6 months
Secondary outcome [2] 0 0
Indication for prescription of Forxiga in routine Australian clinical practice
Timepoint [2] 0 0
Upto 6 months
Secondary outcome [3] 0 0
Change in efficacy and safety variables after treatment with Forxiga for at least 3 months
Timepoint [3] 0 0
Baseline and 3 months
Secondary outcome [4] 0 0
Subgroup analyses may be conducted for selected safety parameters
Timepoint [4] 0 0
Upto 6 months

Eligibility
Key inclusion criteria
Patients with Type 2 Diabetes who are:

- Prescribed Forxiga for glycaemic management AND

- Who have the ability to provide informed consent
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with whom use of Forxiga is contraindicated:

- Patients with Type 1 Diabetes

- Patients with moderate to severe renal impairment [Creatinine clearance (CrCl) <60
mL/min or estimated glomerular filtration rate (eGFR) <60mL/min/1.73m²]

Additional exclusion criteria:

- Age >75 years

- Concomitant use of loop diuretics or pioglitazone

- Patients who are currently on another SGLT2 inhibitor

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2015
Sample size
Target
5000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Local Institution - Clayton
Recruitment postcode(s) [1] 0 0
VIC 3168 - Clayton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The study purpose is to assess adverse events in patients with Type 2 diabetes who have newly
been prescribed Forxiga for the management of glycemic control
Trial website
https://clinicaltrials.gov/ct2/show/NCT01944618
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sophia Zoungas, Professor
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01944618