Evaluation of the Clinical and Economic Outcomes Associated With Exenatide Versus Basal Insulin in People With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 18,000
- 试验地点
- 1
- 主要终点
- Changes from baseline in HbA1c (%)
研究概览
简要总结
This is a retrospective cohort study based on Clinical Practice Research Datalink (CPRD) database analysis to compare therapy effectiveness, and cost between exenatide and basal insulin in patients with type 2 diabetes.
Type 2 diabetes (T2DM) is a chronic condition characterized by elevated blood sugar levels (hyperglycaemia) that can result in an increased risk of a variety of conditions including heart disease, strokes, kidney failure, blindness and amputation. Whilst initially patients may control their blood sugar by lifestyle modification (diet and exercise), ultimately most will require therapeutic intervention with regimens that increase in complexity as T2DM progresses. Exenatide is a relatively recent anti-diabetic drug which is known to lead to weight loss as well as improved blood glucose control. It has also been associated with reduced heart attacks and strokes. In this study CPRD database will be used to compare outcomes for patients prescribed exenatide compared with those prescribed insulin; a more established treatment for T2DM. In particular changes from baseline in blood sugar control and weight will be considered as the primary outcomes. As the choice to treat with exenatide or insulin will be related to patient characteristics which may in themselves be associated with the outcomes of the study we aim to match study patients on some of these key variables and adjust for others in our analysis.
详细描述
Objectives of the study To compare changes in HbA1c and weight from baseline in patients initiated exenatide based-therapy regimen with those initiated insulin-based therapy regimen among type 2 diabetes patients who were injectable naïve in primary care in UK. Health care utilization will be calculated for each of the treatment cohorts, and compared.
Data source Patients will be selected from the Clinical Practice Research Datalink (CPRD), a longitudinal, anonymized research database derived from nearly 700 primary-care practices in the UK. These practices are considered representative of the UK as a whole. The primary-care dataset (CPRD GOLD) comprises data on demographics, diagnoses, hospital referrals, prescriptions emanating in primary care, and other aspects of patient care. Approximately 60% of practices participate in a linkage scheme, by which their patient records are linked to other data sources, including the Hospital Episode Statistics (HES) dataset which provides data on all inpatient and outpatient contacts occurring within National Health Service hospitals in England, and the Office for National Statistics (ONS) mortality dataset. Diagnostic information in the CPRD primary-care dataset is recorded using the Read code classification a UK primary-care practice standard. HES inpatient data are recorded using the International Classification of Disease codes, 10th revision (ICD-10); ONS mortality data are recorded using the ICD-10 and ICD-9 classifications.
Patient identification and Method
Patients defined by CPRD as being of acceptable research quality will be classified as having type 2 diabetes if they had a Read code indicative of diabetes and at least one of the following selection criteria applies:
- more than one diagnostic record exclusively for type 2 diabetes,
- prescriptions for two or more different classes of non-insulin glucose-lowering therapy,
- a diagnostic code indicative of type 2 diabetes (regardless of conflicting diagnoses of type 1 or nonspecific diabetes) plus a prescription for a non-insulin glucose lowering therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetic patients who initiated therapy with exenatide or basal insulin between 2009 and 2014.
排除标准
- •prior injectable diabetes therapy
- •less than 365 days between the latter of the patient's CPRD registration date/practice up-to-standard date and study index date.
- •less than 90 days continuous exposure to Exenatide or basal insulin
研究组 & 干预措施
basal insulin_2
type 2 diabetes patients who were first prescribed with basal insulin in the index period and matched with exenatide twice daily group identified from CPRD database of UK primary care
干预措施: basal insulin (Drug)
exenatide once weekly
type 2 diabetes patients who were first prescribed with exenatide once weekly in the index period identified from CPRD database of UK primary care
干预措施: exenatide once weekly (Drug)
basal insulin_1
type 2 diabetes patients who were first prescribed with basal insulin in the index period and matched with exenatide once weekly group identified from CPRD database of UK primary care
干预措施: basal insulin (Drug)
exenatide twice daily
type 2 diabetes patients who were first prescribed with exenatide twice daily in the index period identified from CPRD database of UK primary care
干预措施: exenatide twice daily (Drug)
结局指标
主要结局
Changes from baseline in HbA1c (%)
时间窗: 6, 12 and 24 months
Changes in HbA1c at 6 months, 12 months and 24 months after initiation of the treatment with exenatide and basal insulin will be calculated and compared.
Changes from baseline in weight (kg)
时间窗: 6, 12 and 24 months
Changes in weight at 6 months, 12 months and 24 months after initiation of the treatment with exenatide and basal insulin will be calculated and compared.
Changes from baseline in composite outcomes of HbA1c<=7.0% and weight reduction
时间窗: 6, 12 and 24 months
Changes in composite outcome of HbA1c\<=7.0% and any weight reduction or HbA1c\<=7.0% and weight reduction\>=5% at 6 months, 12 months and 24 months after initiation of the treatment with exenatide and basal insulin will be calculated and compared.
次要结局
- Health care utilization(12 months)