forREAL: FORXIGA PRESCRIPTION EVENT MONITORING PROGRAM (PEMP)

Study Overview
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Brief Summary
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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
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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

Official Title
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forREAL: FORXIGA (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE) PRESCRIPTION EVENT MONITORING PROGRAM

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Forxiga


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| T2DM patients newly prescribed Forxiga<br>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<br>* 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.<br>* Other names: Dapagliflozin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Assessed in patients with Type 2 diabetes who are treated with Forxiga in routine Australian clinical practice | Up to 6 months | 
| 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 |  | Up to 6 months | 
| Incidence rates of spontaneously reported hypoglycaemia in patients with Type 2 diabetes who are treated with Forxiga in routine Australian clinical practice |  | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of prescribing of Forxiga after its introduction to routine Australian clinical practice |  | Upto 6 months | 
| Indication for prescription of Forxiga in routine Australian clinical practice |  | Upto 6 months | 
| Change in efficacy and safety variables after treatment with Forxiga for at least 3 months | Including: HbA1c Weight Systolic blood pressure Diastolic blood pressure Heart rate Serum creatinine Estimated glomerular filtration rate Liver function tests [Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), or bilirubin] | Baseline and 3 months | 
| Subgroup analyses may be conducted for selected safety parameters | Subgroups to be evaluated will include gender, age, diabetes duration, concomitant medication, past medical history, and measured laboratory variables (if available) | Upto 6 months |