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Participant Data obtained to 30Sep2015:
Baseline data: 447 6 month data: 253 Program terminated: recruitment target not met. No analysis will be provided.
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| Name | Class |
|---|---|
| Monash University | OTHER |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Forxiga | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Patients with Type 2 Diabetes who are:
Exclusion Criteria:
Patients with whom use of Forxiga is contraindicated:
Additional exclusion criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Sophia Zoungas, Professor | Monash University | Study Director |
| Christopher Reid, Professor | Monash University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Clayton | Victoria | VIC 3168 | Australia |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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| Change in efficacy and safety variables after treatment with Forxiga for at least 3 months | Including:
| 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 |
| D004700 | Endocrine System Diseases |