Clinical trial NCT01944618: forREAL: FORXIGA PRESCRIPTION EVENT MONITORING PROGRAM (PEMP)
Official title: forREAL: FORXIGA (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE) PRESCRIPTION EVENT MONITORING PROGRAM
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Type 2 Diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Monash University
First posted: 2013-09-17
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Type 2 Diabetes whom the Healthcare professional (HCP) would consider as suitable candidates for Forxiga treatment will be invited to participate in the program during routine clinical assessment

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

Detailed description: Observational Model: Other: A post-marketing evaluation of the safety of Forxiga 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

Eligibility criteria: Inclusion Criteria:

Patients with Type 2 Diabetes who are:

* Prescribed Forxiga for glycaemic management AND
* Who have the ability to provide informed consent

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

Primary outcomes:
measure: 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
timeFrame: Up to 6 months
measure: 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
timeFrame: Up to 6 months
measure: Incidence rates of spontaneously reported hypoglycaemia in patients with Type 2 diabetes who are treated with Forxiga in routine Australian clinical practice
timeFrame: Up to 6 months
Secondary outcomes:
measure: Rate of prescribing of Forxiga after its introduction to routine Australian clinical practice
timeFrame: Upto 6 months
measure: Indication for prescription of Forxiga in routine Australian clinical practice
timeFrame: Upto 6 months
measure: Change in efficacy and safety variables after treatment with Forxiga for at least 3 months
timeFrame: Baseline and 3 months
measure: Subgroup analyses may be conducted for selected safety parameters
timeFrame: Upto 6 months
Other outcomes:
Locations:
city: Clayton
country: Australia
facility: Local Institution
state: Victoria
Study officials:
affiliation: Monash University
name: Sophia Zoungas, Professor
role: STUDY_DIRECTOR
affiliation: Monash University
name: Christopher Reid, Professor
role: STUDY_DIRECTOR
References: