CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 888 enrolled
Drug / intervention
exenatide +1 moredrug
Likely dose
exenatide 5mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01060059
NCT01060059N/ACompleted

EBIRIOS - Exenatide and Basal Insulins Use in the Real Setting: an Italian Observational Study in Patients With Type 2 Diabetes and Secondary Failure of Oral Antihyperglycemic Treatment

AstraZeneca·observational·Posted Feb 2, 2010·Updated Apr 9, 2015

In Brief

An observational study evaluating exenatide and basal insulin for Type 2 Diabetes Mellitus. Completed, enrolled 888 participants across 50 sites.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2, 2010
Enrollment StartApr 1, 2010
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 16.4 years ago

Interventions

exenatidedrug

subcutaneous injection, 5mcg or 10mcg, twice a day

basal insulindrug

subcutaneous injection, dosing according to physician's clinical judgment