forREAL: FORXIGA PRESCRIPTION EVENT MONITORING PROGRAM (PEMP)

Type 2 Diabetes Clinical Trial

— forREAL  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01944618
• Other study ID #: MB102-209
• Status: Terminated
• Phase: N/A
• First received: September 13, 2013
• Last updated: September 12, 2016
• Start date: October 2013
• Est. completion date: October 2015

Study information

• Verified date: September 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5000
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
Australia	Local Institution	Clayton	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Monash University

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	Rate of prescribing of Forxiga after its introduction to routine Australian clinical practice		Upto 6 months	No
Secondary	Indication for prescription of Forxiga in routine Australian clinical practice		Upto 6 months	No
Secondary	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	No
Secondary	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	No

External Links

•   FDA Safety Alerts and Recalls