forREAL: FORXIGA PRESCRIPTION EVENT MONITORING PROGRAM (PEMP)

AstraZeneca

Status: Terminated

Conditions: Type 2 Diabetes

Treatments: Drug: Forxiga

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01944618

MB102-209

Details and patient eligibility

About

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

Full 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

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

5,000 participants in 1 patient group

T2DM patients newly prescribed Forxiga

Description:

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.

Treatment:

Drug: Forxiga