CHOICE: CHanges to Treatment and Outcomes in Patients With Type 2 Diabetes Initiating InjeCtablE Therapy

AstraZeneca

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: any human insulin or analog insulin(s) given in any regimen by subcutaneous injection; Drug: exenatide

Study type: Observational

Funder types: Industry

Identifiers

NCT00635492

H8O-EW-B005

Details and patient eligibility

About

Patients initiating injectable therapy for type 2 diabetes (insulin or exenatide) in usual clinical practice will be enrolled and followed up for two years in order to describe actual practice with regards to the time on initial treatment regime, whether treatment regimens are being modified, what treatment modifications are made, and clinical and patient-reported outcomes.

Enrollment: 2,515 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• are aged 18 or above
• diagnosed with type 2 diabetes
• have had a treatment decision made within the normal course of care to initiate either insulin or exenatide for the treatment of type 2 diabetes
• have not previously been treated with either insulin or exenatide
• are not simultaneously participating in another study which includes an investigational drug or procedure at study entry
• have been fully informed and given their written consent for use of their data
• have sufficient understanding of the primary language of their country such that they will be able to complete the questionnaires.

Trial design

2,515 participants in 2 patient groups

1

Description:

exenatide

Treatment:

Drug: exenatide

2

Description:

insulin

Treatment:

Drug: any human insulin or analog insulin(s) given in any regimen by subcutaneous injection