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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 888
- 试验地点
- 1
- 主要终点
- Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤ 7.0% With Minimal Weight Gain (≤ 1 Kg) at Month 12.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: exenatide (Drug)
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.
干预措施: basal insulin (Drug)
结局指标
主要结局
Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤ 7.0% With Minimal Weight Gain (≤ 1 Kg) at Month 12.
时间窗: Baseline, Month 12
Percentage of patients who achieved glycemic target of HbA1c ≤ 7.0% with minimal weight gain (≤ 1 Kg) at month 12.
次要结局
- Percentage of Patients Achieving a Weight Decrease >=3% Between Baseline and Month 12(Baseline, Month 12)
- Changes in Fasting Total Cholesterol Between Baseline and Month 12(Baseline, Month 12)
- Changes in Fasting HDL Between Baseline and Month 12(Baseline, Month 12)
- Changes in Fasting LDL Between Baseline and Month 12(Baseline, Month 12)
- Changes in Fasting Triglycerides Between Baseline and Month 12(Baseline, 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(Baseline, Month 12)
- Percentage of Patients With Hypoglycemia Episodes Between Baseline and Month 12(Baseline to Month 12)
- Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline(baseline)
- Percentage of Patients With HbA1c Reduction From Baseline >= 1.0% at Month 12(Baseline, Month 12)
- Changes in Weight From Baseline to 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 Achieving HbA1c Concentration <=7.0% at Month 12(Month 12)
- Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12(Month 12)
- Percentage of Patients Achieving a Weight Decrease >=5% Between Baseline and Month 12(Baseline, Month 12)
- Factor of 1 Percent (%) Higher Baseline HbA1c Associated With Treatment Choice at Baseline(baseline)
- Factor of Longer Duration of Diabetes Associated With Treatment Choice at Baseline(baseline)
- Factor of Older Age Associated With Treatment Choice at Baseline(baseline)
- Factor of Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline(baseline)
- Factor of Greater Height Associated With Treatment Choice at Baseline(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(baseline)