A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In Type 2 Diabetes Patients On Pharmacotherapy (INSIGHT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 4,911
- 试验地点
- 1
- 主要终点
- Diabetic Quality of Life using Modified 15 item DQoL (MDQoL) questionnaire
研究概览
简要总结
This is a non-interventional, cross sectional, multicentric study in T2DM patients which will involve a single visit for study related procedures. This study will be conducted in approximately 5,000 patients at around 300 hospitals/primary care clinics across India. Approximately 18-20 patients per site will be enrolled. This study has been designed to evaluate diabetes related quality of life (DQoL), frequency and impact of hypoglycaemia in relation to HbA1c control and to assess disease modifying variables-BMI and BP in T2DM patients on oral / injectable anti-diabetic drugs with/without insulin therapy.
详细描述
A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In Type 2 Diabetes Patients On Pharmacotherapy (INSIGHT)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •Patients with diagnosis of T2DM for > 1 year prior to entry in the study willing and able to complete the questionnaire and on pharmacotherapy
- •Patients who are currently treated with a single or combination of injectable/oral antidiabetic drugs with or without insulin therapy
- •Treatment type must be unchanged in the previous 3 months. However, dose modifications are allowed
- •Patients who agree to participate in the study and give their written informed consent
排除标准
- •Patients with type 1 diabetes
- •Patients with diabetic ketoacidosis and/or hyperosmolar hyperglycaemic state
- •Patients with secondary diabetes (including disease of the exocrine pancreas, endocrinopathies)
- •Patients with concurrent treatment involving systemic glucocorticoids. However, inhaled, locally injected and topical use of glucocorticoids is allowed
- •Patients suffering from severe cardiac, hepatic, renal diseases as judged by the investigator
- •Any condition of the patient which may have an impact on objective and outcome of the trial example: patients currently undergoing major/ minor surgical
结局指标
主要结局
Diabetic Quality of Life using Modified 15 item DQoL (MDQoL) questionnaire
时间窗: 2nd February 2012 - 2nd August 2012
次要结局
- HbA1c and its correlation with frequency of hypoglycemia(2nd February 2012 - 2nd August 2012)
- Frequency and impact of hypoglycemia using HFS-II (worry subscale)(2nd February 2012 - 2nd August 2012)
- Disease modifying variables Body Mass Index (BMI) and Blood Pressure (BP)(2nd February 2012 - 2nd August 2012)