Description of Drug Utilization and Assessment of Impact of Saxagliptin on Health Status of Patients With Type 2 Diabetes in France
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,000
- 主要终点
- Retention rate of Saxagliptin and to describe discontinuation rate and reasons
研究概览
简要总结
The purpose of this study is to respond to The French Health Authority which has requested BMS France and Astra Zeneca (AZ) France to set-up a long-term cohort study in a representative sample of French Type 2 Diabetes mellitus (T2D) patients treated with Saxagliptin to generate real world data on drug utilization, joint population, non comparative effectiveness and safety
详细描述
Time Perspective: Ambispective cohort follow by a 18 to 24 month follow up period, Retrospective follow by Prospective.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
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
- •Patient ≥ 18 years old
- •Patient with T2D
- •Ambispective Cohort
- •Patient ≥ 18 years old
- •Patient with T2D
- •Patient initiated with Saxagliptin in the last 6 months before the inclusion or day of inclusion visit (whatever his/her ongoing hypoglycaemic treatment)
- •Patient agreeing to participate, and not yet enrolled by another physician
排除标准
- •Patient participating in a clinical trial
研究组 & 干预措施
Population of patients treated with Saxagliptin
干预措施: Saxagliptin (Drug)
结局指标
主要结局
Retention rate of Saxagliptin and to describe discontinuation rate and reasons
时间窗: At 2 years
Joint population of Saxagliptin based on socio-demographic data, medical history, disease history, comorbidities including renal, hepatic and cardiac functions, HbA1c level at treatment initiation)
时间窗: One year (average)
Evolution of Glycated hemoglobin (HbA1c) level, weight and the onset of hypoglycemic over time (2 years) for patients treated with Saxagliptin
时间窗: 24 months
HbA1c level \<7% at Y2, weight and assessment of hypoglycaemic events after a 2-year exposure to Saxagliptin
Utilization of Saxagliptin by General practitioners (GPs) and diabetologists in France (based on indication, initial dosage and adjustments, co-prescriptions, glycemic monitoring)
时间窗: During the treatment (Up to 2 years)
次要结局
- Distribution of different hypoglycaemic therapeutic strategies used in France and characteristics of T2D patients depending on therapeutic strategies(2 month)
- Saxagliptin utilization according to patient's profile and disease characteristics(24 month)