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

Study Overview
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Brief Summary
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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
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: exenatide
* Drug: basal insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| exenatide<br>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. | Drug: exenatide<br>* subcutaneous injection, 5mcg or 10mcg, twice a day<br>* Other names: BYETTA;|
| basal insulin<br>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. | Drug: basal insulin<br>* subcutaneous injection, dosing according to physician's clinical judgment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in HbA1c From Baseline to Month 12 | Changes in HbA1c from Baseline to Month 12 | Baseline, Month 12 | 
| Changes in Fasting Blood Glucose From Baseline to 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 | 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 | Percentage of Patients Achieving HbA1c Concentration <=7.0% at Month 12 | Month 12 | 
| Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12 | Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12 | Month 12 | 
| Changes in Weight From Baseline to Month 12 | Changes in Weight From Baseline to Month 12 | Baseline, Month 12 | 
| Percentage of Patients Achieving a Weight Decrease >=3% Between Baseline and Month 12 | Percentage of Patients Achieving a Weight Decrease >=3% between Baseline and Month 12 | Baseline, Month 12 | 
| Percentage of Patients Achieving a Weight Decrease >=5% Between Baseline and Month 12 | Percentage of Patients Achieving a Weight Decrease >=5% between Baseline and Month 12 | Baseline, Month 12 | 
| Changes in Fasting Total Cholesterol Between Baseline and Month 12 | Changes in Fasting Total Cholesterol Between Baseline and Month 12 | Baseline, Month 12 | 
| Changes in Fasting HDL Between Baseline and Month 12 | Changes in Fasting HDL Between Baseline and Month 12 | Baseline, Month 12 | 
| Changes in Fasting LDL Between Baseline and Month 12 | Changes in Fasting LDL Between Baseline and Month 12 | Baseline, Month 12 | 
| Changes in Fasting Triglycerides Between Baseline and Month 12 | Changes in Fasting Triglycerides Between Baseline and Month 12 | Baseline, Month 12 | 
| Changes in Diastolic Blood Pressure Between Baseline and Month 12 | Changes in Diastolic Blood Pressure Between Baseline and Month 12 | Baseline, Month 12 | 
| Changes in Systolic Blood Pressure Between Baseline and Month 12 | Changes in Systolic Blood Pressure Between Baseline and Month 12 | Baseline, Month 12 | 
| Percentage of Patients With Hypoglycemia Episodes Between Baseline and Month 12 | Percentage of patients with Hypoglycemia Episodes Between Baseline and Month 12. All episodes consistent with hypoglycemia with or without a confirmatory blood glucose reading were collected. | Baseline to Month 12 | 
| Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline | Number of patients per arm who were evaluated in 3 factors at baseline (gender, presence of medical conditions, and previous gastrointestinal symptoms) were analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. | baseline | 
| Factor of 1 Percent (%) Higher Baseline HbA1c Associated With Treatment Choice at Baseline | Factor of 1% higher baseline HbA1c (from most recent HbA1c) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. HbA1c was measured as a percent of normal (%). | baseline | 
| Factor of Longer Duration of Diabetes Associated With Treatment Choice at Baseline | The Factor of longer duration of diabetes at baseline (diagnosed 1 year longer) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Duration of diabetes was measured in years since the date of diabetes diagnosis. | baseline | 
| Factor of Older Age Associated With Treatment Choice at Baseline | Older age (1 year older) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Age was measured in years. | baseline | 
| Factor of Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline | Factor of higher body mass index (BMI) (1 kilogram per meter squared (kg/m^2) higher) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. BMI measured as kg/m^2. | baseline | 
| Factor of Greater Height Associated With Treatment Choice at Baseline | Factor of greater height (1 centimeter higher) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Height was measured in centimeters (cm) . | 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 | Factors of higher creatinine: 1 milligram per deciliter higher (mg/dL) and higher fasting lipids (HDL cholesterol: 1 mg/dL higher; total cholesterol: 1 mg/dL higher; triglycerides: 1 mg/dL higher) were analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Creatinine and fasting lipids were measured in milligrams per deciliter (mg/dL). | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes; exenatide; Byetta; basal insulin; Amylin; Lilly