forREAL: FORXIGA PRESCRIPTION EVENT MONITORING PROGRAM (PEMP)

Terminated

• Conditions: Type 2 Diabetes
• Interventions: Drug: Forxiga

• Registration Number: NCT01944618
• Lead Sponsor: AstraZeneca

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

Study Timeline

• Study First Submitted: 2013-09-13
• Study First Submitted QC: 2013-09-13
• Study First Posted: 2013-09-17
• Study Start: 2013-10
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-12
• Last Update Posted: 2016-09-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
T2DM patients newly prescribed Forxiga	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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	Baseline and 3 months	Including: * HbA1c; * Weight; * Systolic blood pressure; * Diastolic blood pressure; * Heart rate; * Serum creatinine; * Estimated glomerular filtration rate; * Liver function tests \[Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), or bilirubin\]
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)

Trial Locations

Locations (1)

Local Institution; 🇦🇺 Clayton, Victoria, Australia