MedTrace Logo

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

NCT01060059 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 888

Last updated 2015-04-09

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

exenatide

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

DRUG

basal insulin

subcutaneous injection, dosing according to physician's clinical judgment

Sponsors & Collaborators

Principal Investigators

  • James Malone, MD · Eli Lilly and Company

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01060059 on ClinicalTrials.gov