forREAL: FORXIGA PRESCRIPTION EVENT MONITORING PROGRAM (PEMP) (forREAL)

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

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

Study Overview

• Status: Terminated
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Forxiga

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 Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Clayton, Victoria, Australia, VIC 3168
      • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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.; Other Names: Dapagliflozin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Monash University
• Investigators: Study Director: Sophia Zoungas, Professor, Monash University; Study Director: Christopher Reid, Professor, Monash University

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: September 13, 2013
• First Submitted That Met QC Criteria: September 13, 2013
• First Posted (Estimate): September 17, 2013

Study Record Updates

• Last Update Posted (Estimate): September 13, 2016
• Last Update Submitted That Met QC Criteria: September 12, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Dapagliflozin
• Other Study ID Numbers: MB102-209