Exenatide and Basal Insulins Use in the Real Setting: an Observational Study in Patients With Type 2 Diabetes

AstraZeneca

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: exenatide; Drug: basal insulin

Study type: Observational

Funder types: Industry

Identifiers

NCT01060059

H8O-IT-B014

Details and patient eligibility

About

Although the efficacy and safety profile of exenatide has been well established, few data exist on the real world results of exenatide treatment in specific populations and clinical settings. This study is intended to fill this gap through observing and collecting prospective data from a population of Italian patients initiating treatment with either exenatide or basal insulin formulations after failure to achieve glycemic control with oral antihyperglycemic agents (OHA).

Observational studies represent noninterventional research; therefore, this study does not involve randomization of patients to particular comparator arms or therapies. The term "noninterventional" means that the healthcare providers decisions regarding the proper treatment and care of the patient are made in the course of normal clinical practice. Patients enrolled in this study are enrolling for the collection of their data on observations made during normal clinical practice.

Enrollment: 888 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Are inadequately controlled with single or multiple OHA as evidenced by an HbA1c > 7.0%
2. Have presented during the routine course of care and, together with their physician, have decided to initiate treatment with either exenatide twice daily or conventional insulin therapy with basal insulin (insulin glargine, detemir, protaminated insulin lispro, protaminated human insulin) added to the existing treatment with OHA
3. Have not been treated with GLP-1 receptor agonist for more than 7 consecutive days within 3 months before entering the study
4. Have not been treated with insulins for more than 7 consecutive days within last 3 months or more than 3 months in the course of the disease
5. Are not simultaneously participating in another study which includes an investigational drug or procedure at study entry
6. Have been fully informed and given their written consent for use of their data

Trial design

888 participants in 2 patient groups

exenatide

Description:

The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.

Treatment:

Drug: exenatide

basal insulin

Description:

The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.

Treatment:

Drug: basal insulin