Exenatide and Basal Insulins Use in the Real Setting: an Observational Study in Patients With Type 2 Diabetes
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
1 other identifier
observational
888
1 country
50
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2010
Typical duration for all trials
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2010
CompletedFirst Posted
Study publicly available on registry
February 2, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedResults Posted
Study results publicly available
January 16, 2014
CompletedApril 9, 2015
March 1, 2015
2.1 years
January 26, 2010
July 31, 2013
March 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤ 7.0% With Minimal Weight Gain (≤ 1 Kg) at Month 12.
Percentage of patients who achieved glycemic target of HbA1c ≤ 7.0% with minimal weight gain (≤ 1 Kg) at month 12.
Baseline, Month 12
Secondary Outcomes (22)
Changes in HbA1c From Baseline to Month 12
Baseline, Month 12
Changes in Fasting Blood Glucose From Baseline to Month 12
Baseline, Month 12
Percentage of Patients With HbA1c Reduction From Baseline >= 1.0% at Month 12
Baseline, Month 12
Percentage of Patients Achieving HbA1c Concentration <=7.0% at Month 12
Month 12
Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12
Month 12
- +17 more secondary outcomes
Study Arms (2)
exenatide
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.
basal insulin
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.
Interventions
subcutaneous injection, dosing according to physician's clinical judgment
Eligibility Criteria
The targeted population consists of adult patients with type 2 diabetes mellitus treated in outpatient setting by specialists.
You may qualify if:
- Are inadequately controlled with single or multiple OHA as evidenced by an HbA1c \> 7.0%
- 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
- Have not been treated with GLP-1 receptor agonist for more than 7 consecutive days within 3 months before entering the study
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Eli Lilly and Companycollaborator
Study Sites (50)
Research site
Acquaviva delle Fonti, Italy
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Anzio, Italy
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Bassano del Grappa, Italy
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Bologna, Italy
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Brindisi, Italy
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Cagliari, Italy
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Campi Salentina, Italy
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Casarano, Italy
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Caserta, Italy
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Cesena, Italy
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Chieri, Italy
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Cisternino, Italy
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Copertino, Italy
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Cremona, Italy
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Distretto Vittoria, Italy
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Fermo, Italy
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Ferrara, Italy
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Fidenza, Italy
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Florence, Italy
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Forlì, Italy
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Genova, Italy
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Germaneto, Italy
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Lecce, Italy
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Livorno, Italy
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Lucca, Italy
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Manfredonia (Le), Italy
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Mariano Comense, Italy
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Messina, Italy
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Milan, Italy
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Monza, Italy
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Napoli, Italy
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Novara, Italy
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Olbia, Italy
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Palermo, Italy
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Palmi, Italy
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Parma, Italy
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Pavia, Italy
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Pisa, Italy
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Potenza, Italy
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Rimini, Italy
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Roma, Italy
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Rossano Scalo, Italy
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Salerno, Italy
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San Giovanni Rotondo, Italy
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Schio, Italy
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Sesto San Giovanni, Italy
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Siena, Italy
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Treviso, Italy
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Trieste, Italy
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Varese, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Peter Ohman, Medical Science Director
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
James Malone, MD
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2010
First Posted
February 2, 2010
Study Start
April 1, 2010
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
April 9, 2015
Results First Posted
January 16, 2014
Record last verified: 2015-03