A Multicentre Retrospective Study of Characterization of Treatment Intensified (Add on to Metformin) Real World Adult Population With Type 2 Diabetes Mellitus in India, Pakistan, and Thailand.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- The proportion of patients prescribed glucagon-like peptide-1 receptor agonists (GLP-1 RA)
研究概览
简要总结
This study aims to describe demographics, clinical, treatment and healthcare resource utilization characteristics with a particular focus on those relating to cardiovascular disease in selected treatment intensified patients with type 2 diabetes in the real-world settings in India, Pakistan, and Thailand.
The study will be based on data already recorded in participants medical record and no new tests or procedures are required as part of the study.
The study will last for about 6 months and it does not affect participants current treatment.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
- •Male or female, age above or equal to 18 years at type 2 diabetes mellitus (T2DM) diagnosis
- •Year of birth 1928 or later (age blow 90 years old in 2017)
- •T2DM diagnosis in medical record on or after the date of local GLP-1 RA marketing authorization
- •Medical records documenting prior or ongoing treatment with metformin
- •Medical records documenting treatment with other non-metformin T2DM drugs
排除标准
- •Previous participation in this study. Participation is defined as having given informed consent in this study.
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- •Patients with any diagnosis of type 1 diabetes mellitus (T1DM)
结局指标
主要结局
The proportion of patients prescribed glucagon-like peptide-1 receptor agonists (GLP-1 RA)
时间窗: At Baseline (day 0, defined as the date of first prescription for the most recent antidiabetic medication drug class)
Will be reported as percent of patients
The proportion of patients prescribed cardiovascular disease (CVD) medications
时间窗: Since the start of medical record
Will be reported as percent of patients
BMI (body mass index)
时间窗: 6 months prior to Baseline (day 0, defined as the date of first prescription for the most recent antidiabetic medication drug class) (retrospective)
BMI will be calculated from height and weight data reported as percent of patients
Most recent blood pressure measurement values
时间窗: 6 months prior to Baseline (day 0, defined as the date of first prescription for the most recent antidiabetic medication drug class) (retrospective)
Reported as mmHg
次要结局
未报告次要终点