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

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: exenatide (Drug); basal insulin (Drug)

Phase: N/A

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
James Malone, MD, Study Director, Affiliation: Eli Lilly and Company

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.

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 design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤ 7.0% With Minimal Weight Gain (≤ 1 Kg) at Month 12.

Secondary outcome:

Changes in HbA1c From Baseline to Month 12

Changes in Fasting Blood Glucose From Baseline to Month 12

Percentage of Patients With HbA1c Reduction From Baseline >= 1.0% at Month 12

Percentage of Patients Achieving HbA1c Concentration <=7.0% at Month 12

Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12

Changes in Weight From Baseline to Month 12

Percentage of Patients Achieving a Weight Decrease >=3% Between Baseline and Month 12

Percentage of Patients Achieving a Weight Decrease >=5% Between Baseline and Month 12

Changes in Fasting Total Cholesterol Between Baseline and Month 12

Changes in Fasting HDL Between Baseline and Month 12

Changes in Fasting LDL Between Baseline and Month 12

Changes in Fasting Triglycerides Between Baseline and Month 12

Changes in Diastolic Blood Pressure Between Baseline and Month 12

Changes in Systolic Blood Pressure Between Baseline and Month 12

Percentage of Patients With Hypoglycemia Episodes Between Baseline and Month 12

Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline

Factor of 1 Percent (%) Higher Baseline HbA1c Associated With Treatment Choice at Baseline

Factor of Longer Duration of Diabetes Associated With Treatment Choice at Baseline

Factor of Older Age Associated With Treatment Choice at Baseline

Factor of Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline

Factor of Greater Height Associated With Treatment Choice at Baseline

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Research site, Acquaviva delle Fonti, Italy

Research site, Anzio, Italy

Research site, Bassano del Grappa, Italy

Research site, Bologna, Italy

Research site, Brindisi, Italy

Research site, Cagliari, Italy

Research site, Campi Salentina, Italy

Research site, Casarano, Italy

Research site, Caserta, Italy

Research site, Cesena, Italy

Research site, Chieri, Italy

Research site, Cisternino, Italy

Research site, Copertino, Italy

Research site, Cremona, Italy

Research site, Distretto Vittoria, Italy

Research site, Fermo, Italy

Research site, Ferrara, Italy

Research site, Fidenza, Italy

Research site, Firenze, Italy

Research site, Forlì, Italy

Research site, Genova, Italy

Research site, Germaneto, Italy

Research site, Lecce, Italy

Research site, Livorno, Italy

Research site, Lucca, Italy

Research site, Manfredonia (Le), Italy

Research site, Mariano Comense, Italy

Research site, Messina, Italy

Research site, Milano, Italy

Research site, Monza, Italy

Research site, Napoli, Italy

Research site, Novara, Italy

Research site, Olbia, Italy

Research site, Palermo, Italy

Research site, Palmi, Italy

Research site, Parma, Italy

Research site, Pavia, Italy

Research site, Pisa, Italy

Research site, Potenza, Italy

Research site, Rimini, Italy

Research site, Roma, Italy

Research site, Rossano Scalo, Italy

Research site, Salerno, Italy

Research site, San Giovanni Rotondo, Italy

Research site, Schio, Italy

Research site, Sesto San Giovanni, Italy

Research site, Sienna, Italy

Research site, Treviso, Italy

Research site, Trieste, Italy

Research site, Varese, Italy

Starting date: April 2010
Last updated: March 20, 2015