CHOICE: CHanges to Treatment and Outcomes in Patients With Type 2 Diabetes Initiating InjeCtablE Therapy - A European Observational Study of Patients With Type 2 Diabetes Initiating Injectable Therapy to Determine Time to Treatment Change, Factors Associated With Treatment Changes and Outcomes Over 24 Months
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 2,515
- 试验地点
- 2
- 主要终点
- Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months.
研究概览
简要总结
Patients initiating injectable therapy for type 2 diabetes (insulin or exenatide) in usual clinical practice will be enrolled and followed up for two years in order to describe actual practice with regards to the time on initial treatment regime, whether treatment regimens are being modified, what treatment modifications are made, and clinical and patient-reported outcomes.
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 aged 18 or above
- •diagnosed with type 2 diabetes
- •have had a treatment decision made within the normal course of care to initiate either insulin or exenatide for the treatment of type 2 diabetes
- •have not previously been treated with either insulin or exenatide
- •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
- •have sufficient understanding of the primary language of their country such that they will be able to complete the questionnaires.
排除标准
- 未提供
研究组 & 干预措施
1
exenatide
干预措施: exenatide (Drug)
2
insulin
干预措施: any human insulin or analog insulin(s) given in any regimen by subcutaneous injection (Drug)
结局指标
主要结局
Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months.
时间窗: Month 24
The primary objective of this study is to estimate the time spent on initial treatment regime before significant treatment change for patients with type 2 diabetes initiating therapy with either insulin or exenatide for the first time. Initial treatment regime is defined as the treatment regime prescribed when the patient is enrolled in the study. Significant treatment change for patients initiated on insulin or exenatide is defined as at least one of the following: Insulin: * Addition of a new medication for the treatment of type 2 diabetes * A change in the number of times insulin is administered per day * Discontinuation of any insulin initiated at baseline * Substitution of a human insulin for an analogue insulin or vice-versa. * Switching between brands of the same class/type of insulin is not included in the definition of significant treatment change. Exenatide: * Addition of a new medication for the treatment of type 2 diabetes * Discontinuation of exenatide.
次要结局
- Higher Hemoglobin A1c (HbA1) Associated With Treatment Choice at Baseline(Baseline)
- Higher Random Glucose Associated With Treatment Choice at Baseline(6 months prior to Baseline)
- Higher Value of Low Density Lipoprotein Cholesterol Associated With Treatment Choice at Baseline(Baseline)
- Changes in HbA1c From Baseline to Month 24(Baseline, Month 24)
- Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24(Month 24)
- Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24(Month 24)
- Frequent Blood Glucose Self Monitoring Associated With Treatment Choice at Baseline(4 weeks prior to Baseline)
- Reasons for Discontinuation of Baseline Regimen(Baseline to Month 24)
- Factors Associated With Treatment Change in Exenatide BID Cohort(Baseline to Month 24)
- Disinhibited Eating Associated With Treatment Choice at Baseline(Baseline)
- Incidence of Hypoglycemia Between Baseline and 24 Months(Baseline to Month 24)
- Percentage of Patients Hospitalized Between Baseline and 24 Months(Baseline to Month 24)
- Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline(Baseline)
- Changes in Weight From Baseline to Month 24(Baseline, Month 24)
- Factors Associated With Treatment Change in Insulin Cohort(Baseline to Month 24)
- Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months(Baseline to Month 24)
- Number of Contacts With Health Care Providers Between Baseline and 24 Months(Baseline to Month 24)
- Older Age Associated With Treatment Choice at Baseline(Baseline)
- Diet and Exercise Advice in Diabetes Management Associated With Treatment Choice at Baseline(Baseline)
- Incidence of Gastro Intestinal Symptoms Between Baseline and 24 Months(Baseline to Month 24)