Clinical trial NCT01060059: Exenatide and Basal Insulins Use in the Real Setting: an Observational Study in Patients With Type 2 Diabetes
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes; exenatide; Byetta; basal insulin; Amylin; Lilly
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2010-02-02
Enrollment: 888
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The targeted population consists of adult patients with type 2 diabetes mellitus treated in outpatient setting by specialists.

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.


Eligibility criteria: Inclusion Criteria:

1. Are inadequately controlled with single or multiple OHA as evidenced by an HbA1c \> 7.0%
2. 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
3. Have not been treated with GLP-1 receptor agonist for more than 7 consecutive days within 3 months before entering the study
4. 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
5. Are not simultaneously participating in another study which includes an investigational drug or procedure at study entry
6. Have been fully informed and given their written consent for use of their data

Primary outcomes:
measure: Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤ 7.0% With Minimal Weight Gain (≤ 1 Kg) at Month 12.
timeFrame: Baseline, Month 12
Secondary outcomes:
measure: Changes in HbA1c From Baseline to Month 12
timeFrame: Baseline, Month 12
measure: Changes in Fasting Blood Glucose From Baseline to Month 12
timeFrame: Baseline, Month 12
measure: Percentage of Patients With HbA1c Reduction From Baseline >= 1.0% at Month 12
timeFrame: Baseline, Month 12
measure: Percentage of Patients Achieving HbA1c Concentration <=7.0% at Month 12
timeFrame: Month 12
measure: Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12
timeFrame: Month 12
measure: Changes in Weight From Baseline to Month 12
timeFrame: Baseline, Month 12
measure: Percentage of Patients Achieving a Weight Decrease >=3% Between Baseline and Month 12
timeFrame: Baseline, Month 12
measure: Percentage of Patients Achieving a Weight Decrease >=5% Between Baseline and Month 12
timeFrame: Baseline, Month 12
measure: Changes in Fasting Total Cholesterol Between Baseline and Month 12
timeFrame: Baseline, Month 12
measure: Changes in Fasting HDL Between Baseline and Month 12
timeFrame: Baseline, Month 12
measure: Changes in Fasting LDL Between Baseline and Month 12
timeFrame: Baseline, Month 12
measure: Changes in Fasting Triglycerides Between Baseline and Month 12
timeFrame: Baseline, Month 12
measure: Changes in Diastolic Blood Pressure Between Baseline and Month 12
timeFrame: Baseline, Month 12
measure: Changes in Systolic Blood Pressure Between Baseline and Month 12
timeFrame: Baseline, Month 12
measure: Percentage of Patients With Hypoglycemia Episodes Between Baseline and Month 12
timeFrame: Baseline to Month 12
measure: Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline
timeFrame: baseline
measure: Factor of 1 Percent (%) Higher Baseline HbA1c Associated With Treatment Choice at Baseline
timeFrame: baseline
measure: Factor of Longer Duration of Diabetes Associated With Treatment Choice at Baseline
timeFrame: baseline
measure: Factor of Older Age Associated With Treatment Choice at Baseline
timeFrame: baseline
measure: Factor of Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline
timeFrame: baseline
measure: Factor of Greater Height Associated With Treatment Choice at Baseline
timeFrame: baseline
measure: Factors of Higher Creatinine, Higher Fasting High Density Lipoprotein (HDL) Cholesterol, Higher Fasting Cholesterol, and Higher Fasting Triglycerides Which Were Associated With Treatment Choice at Baseline
timeFrame: baseline
Other outcomes:
Locations:
city: Acquaviva delle Fonti
country: Italy
facility: Research site
city: Anzio
country: Italy
facility: Research site
city: Bassano del Grappa
country: Italy
facility: Research site
city: Bologna
country: Italy
facility: Research site
city: Brindisi
country: Italy
facility: Research site
city: Cagliari
country: Italy
facility: Research site
city: Campi Salentina
country: Italy
facility: Research site
city: Casarano
country: Italy
facility: Research site
city: Caserta
country: Italy
facility: Research site
city: Cesena
country: Italy
facility: Research site
city: Chieri
country: Italy
facility: Research site
city: Cisternino
country: Italy
facility: Research site
city: Copertino
country: Italy
facility: Research site
city: Cremona
country: Italy
facility: Research site
city: Distretto Vittoria
country: Italy
facility: Research site
city: Fermo
country: Italy
facility: Research site
city: Ferrara
country: Italy
facility: Research site
city: Fidenza
country: Italy
facility: Research site
city: Firenze
country: Italy
facility: Research site
city: Forlì
country: Italy
facility: Research site
city: Genova
country: Italy
facility: Research site
city: Germaneto
country: Italy
facility: Research site
city: Lecce
country: Italy
facility: Research site
city: Livorno
country: Italy
facility: Research site
city: Lucca
country: Italy
facility: Research site
city: Manfredonia (Le)
country: Italy
facility: Research site
city: Mariano Comense
country: Italy
facility: Research site
city: Messina
country: Italy
facility: Research site
city: Milano
country: Italy
facility: Research site
city: Monza
country: Italy
facility: Research site
city: Napoli
country: Italy
facility: Research site
city: Novara
country: Italy
facility: Research site
city: Olbia
country: Italy
facility: Research site
city: Palermo
country: Italy
facility: Research site
city: Palmi
country: Italy
facility: Research site
city: Parma
country: Italy
facility: Research site
city: Pavia
country: Italy
facility: Research site
city: Pisa
country: Italy
facility: Research site
city: Potenza
country: Italy
facility: Research site
city: Rimini
country: Italy
facility: Research site
city: Roma
country: Italy
facility: Research site
city: Rossano Scalo
country: Italy
facility: Research site
city: Salerno
country: Italy
facility: Research site
city: San Giovanni Rotondo
country: Italy
facility: Research site
city: Schio
country: Italy
facility: Research site
city: Sesto San Giovanni
country: Italy
facility: Research site
city: Sienna
country: Italy
facility: Research site
city: Treviso
country: Italy
facility: Research site
city: Trieste
country: Italy
facility: Research site
city: Varese
country: Italy
facility: Research site
Study officials:
affiliation: Eli Lilly and Company
name: James Malone, MD
role: STUDY_DIRECTOR
References: