Type 2 Diabetes
Conditions
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
Interventions
DRUGForxiga
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.
Sponsors
Monash University
AstraZeneca
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to 6 months | Assessed in patients with Type 2 diabetes who are treated with Forxiga in routine Australian clinical practice |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of prescribing of Forxiga after its introduction to routine Australian clinical practice | Upto 6 months | — |
| Subgroup analyses may be conducted for selected safety parameters | Upto 6 months | Subgroups to be evaluated will include gender, age, diabetes duration, concomitant medication, past medical history, and measured laboratory variables (if available) |
| 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 | Baseline and 3 months | Including: * HbA1c * Weight * Systolic blood pressure * Diastolic blood pressure * Heart rate * Serum creatinine * Estimated glomerular filtration rate * Liver function tests \[Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), or bilirubin\] |
Countries
Australia
Outcome results
None listed