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
Sponsor study identifier
observational
888
1 country
50
Study Start
April 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2012
Actual (reported)Study Completion
May 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 26, 2010
Actual (reported)February 2, 2010
Actual (reported)April 2010
Date type not reportedThis date has not been verified as actual or estimated.
May 2012
Actual (reported)May 2012
Actual (reported)January 16, 2014
Actual (reported)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
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
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.
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.
subcutaneous injection, 5mcg or 10mcg, twice a day
subcutaneous injection, dosing according to physician's clinical judgment
The targeted population consists of adult patients with type 2 diabetes mellitus treated in outpatient setting by specialists.
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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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James Malone, MD
Eli Lilly and Company
888 participants (actual enrollment reported by the registry).
First Submitted
January 26, 2010
First Posted
February 2, 2010
Study Start
April 2010
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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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Naples, 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
Primary Completion
May 2012
Actual (reported)Study Completion
May 2012
Actual (reported)Last Updated
April 9, 2015
Results First Posted
January 16, 2014
Record last verified: 2015-03
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Source: ClinicalTrials.gov.
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