A Cohort Study of the Benefits of Bydureon in Customary Clinical Care in the United States
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 7,000
- 试验地点
- 1
- 主要终点
- Changes from baseline in HbA1c (%)
研究概览
简要总结
Exenatide once weekly (Bydureon) was approved in January 2012 by FDA in USA for the treatment of type 2 diabetes mellitus. Evidence from clinical trials suggested that Bydureon improves glucose control with low risk of hypoglycemia. Bydureon does not require a dose titration as necessary for other glucagon-like peptide-1 agonists, and appears to have other advantages, such as reducing insulin resistance, reducing weight, and improving blood pressure and lipid profiles. However, the degree to which these advantages of Bydureon lead to improve outcomes in customary clinical care is unknown.
The aim of this study is to evaluate the effectiveness and tolerability of Bydureon relative to basal insulin initiated as first-ever injectable therapeutic regimens used in customary clinical care. Patients who initiated treatment with Bydureon or basal insulin between July 2011 and March 2015 will be recruited into the study cohorts from Optum's database of electronic health records. The two treatment cohorts will be matched by propensity score method.Clinical outcomes of HbA1c, weight, and gastrointestinal symptoms and hypoglycemia are investigated.
详细描述
Background: In January 2012, the US Food and Drug Administration approved a once-weekly form of exenatide, Bydureon, for the treatment of type 2 diabetes mellitus. Evidence from clinical trials suggested that Bydureon improves glucose control with low risk of hypoglycemia. Bydureon does not require a dose titration as necessary for other glucagon-like peptide-1 receptor agonists (GLP-1RAs), and appears to have other advantages, such as reducing insulin resistance, preventing weight gain, and improving blood pressure and lipid profiles. However, the degree to which these advantages of Bydureon lead to improve outcomes in customary clinical care is unknown.
Aims: The aim of this study is to evaluate the effectiveness and tolerability of Bydureon relative to basal insulin initiated as first-ever injectable therapeutic regimens used in customary clinical care.
The specific study objectives are as follows:
- To quantify the effectiveness of Bydureon initiation relative to initiation of basal insulin, on improving:
- Glycated hemoglobin (HbA1c)
- Weight (body mass index (BMI))
- HbA1c simultaneous to reduction in weight
- Blood pressure and lipid profiles
- To monitor the tolerability of Bydureon initiation relative to initiation basal insulin, on the occurrence of :
- Hypoglycemia
- Gastrointestinal symptoms (nausea, vomiting, diarrhea, and constipation)
- Change in the markers for renal disease (estimated glomerular filtration rate (eGFR), serum creatinine, and albumin/creatinine ratio (ACR), and the stability of liver function test (AST, ALT) and standard blood counts (white blood cell, red blood cell, Hematocrit, Hemoglobin, Platelet)
- To examine these measures of effectiveness and tolerability within potentially vulnerable subgroups of Bydureon and basal insulin initiators:
- Type 2 diabetes patients with renal impairment
- Elderly Type 2 diabetes patients
- Type 2 diabetes patients who are a minority race
- Type 2 diabetes patients within strata of HBA1c Design: This retrospective cohort study will be conducted using Optum's electronic health record data from July 2011 through March 2015 and identified injectable-naive Type 2 diabetes patients who initiated either Bydureon or basal insulin during the accrual period, January 2012 and January 2015. Injectable-naive Type 2 diabetes patients will be identified. Propensity score methods will be used to match initiators of Bydureon to basal insulin initiators.
Study Population:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years old;
- •had received care documented in Electronic Health Records (including at least one out-patient provider visit) for a minimum of 6-months prior index date;
- •had at least one diagnosis of type 2 diabetes by The International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM: 250.X0 or 250.X2) prior to and including the date of the study drug initiation, with no prior diagnosis of type1 diabetes (ICD-9-CM: 250.X1 or 250.X3), or gestational diabetes within the 6-months prior to index date;
- •No evidence of prior injectable antidiabetic treatment, specifically no dispensing of a GLP-1RA or any insulin during the 6-months baseline period prior to study drug initiation
排除标准
- •Prior diagnosis of type1 diabetes (ICD-9-CM: 250.X1 or 250.X3), or gestational diabetes within the 6-months prior to index date;
- •Prior dispensing of a GLP-1RA or any insulin
研究组 & 干预措施
exenatide once weekly
type 2 diabetes who initiated exenatide once weekly treatment in the index period
干预措施: exenatide once weekly (Drug)
basal insulin
type 2 diabetes patients who initiated basal insulin treatment in the index period
干预措施: basal insulin (Drug)
结局指标
主要结局
Changes from baseline in HbA1c (%)
时间窗: one year post-index
To evaluate changes in HbA1c from baseline one year after starting treatment with exenatide once weekly and basal insulin
Changes from baseline in weight (kg)
时间窗: one year post-index
To evaluate changes in weight (kg) from baseline one year after starting treatment with exenatide once weekly and basal insulin
次要结局
- Frequency of vomiting(one year post-index)
- Frequency of diarrhea and constipation(One year post-index)
- Frequency of hypoglycemia(one year post-index)
- Frequency of nausea(One year post-index)