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

NCT01060059 · Completed

Last updated 2026-05-28

This study observed how well a diabetes medication called exenatide, combined with long-acting insulin, worked in adults with type 2 diabetes to help control blood sugar while keeping weight gain to a minimum over 12 months.

Status Completed The study has finished.

Type Observational

Participants 888 people

Who can join Ages 18+ · all sexes

Timeline Started 2010-04 · est. completion 2012-05

Where 50 sites · Italy

What this study is testing ClinicalTrials.gov NCT01060059 ↗

Description as written by the study sponsor.

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.

Treatments tested

exenatide also known as BYETTA Drug

subcutaneous injection, 5mcg or 10mcg, twice a day
basal insulin Drug

subcutaneous injection, dosing according to physician's clinical judgment

Main thing measured	Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤ 7.0% With Minimal Weight Gain (≤ 1 Kg) at Month 12.
Sponsor	AstraZeneca
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01060059 ↗