An observational study in Type 2 Diabetes, sponsored by AstraZeneca. Terminated at 1 site in Australia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-09-13.
Sponsored by AstraZeneca · Observational
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
AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Patients with Type 2 Diabetes who are:
Exclusion Criteria:
Patients with whom use of Forxiga is contraindicated:
Additional exclusion criteria:
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
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.
Also known as: Dapagliflozin
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
Time frame: 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
Time frame: 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
Time frame: Up to 6 months
Rate of prescribing of Forxiga after its introduction to routine Australian clinical practice
Time frame: Upto 6 months
Indication for prescription of Forxiga in routine Australian clinical practice
Time frame: 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 \[Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), or bilirubin\]
Time frame: 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)
Time frame: Upto 6 months
This study is terminated, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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