Post-authorization Safety Study in Patients With Type 2 Diabetes Mellitus to Assess the Incidence of Ketoacidosis, Severe Complications of Urinary Tract Infection, Volume Depletion, and Dehydration Among Patients Treated With Empagliflozin or DPP-4 Inhibitors in Saudi Arabia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,502
- 试验地点
- 21
- 主要终点
- Number of Participants With Ketoacidosis
研究概览
简要总结
The objectives of this study are to assess the risk of ketoacidosis, severe urinary tract infections, volume depletion, and dehydration associated in patients with T2DM initiating Empagliflozin compared to patient initiating a dipeptidyl peptidase-4 (DPP-4) inhibitors over a 12-month period of follow-up, including the month of Ramadan
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 who have signed Informed consent form.
- •The patients will be at least 18 years old at index date, diagnosed with Type 2 diabetes mellitus (T2DM) in Saudi Arabia, and who will initiate Empagliflozin or Dipeptidyl-peptidase 4 (DPP4) inhibitors treatment according to the local label and at the discretion of the treating physician during the study period, who have not used other sodium/glucose co-transporter 2 (SGLT2) or DPP4 inhibitors during the previous 12 months.
排除标准
- •Known hypersensitivity to Empagliflozin, the comparator DPP-4 inhibitors or any of their excipients
- •Patients for whom Empagliflozin or the comparator DPP-4 inhibitor is contraindicated according Saudi Food and Drug Authority (SFDA) approved label
- •Patients prescribed fixed-dose combinations of SGLT2 inhibitors with DPP-4 inhibitors will be excluded.
- •The same inclusion and exclusion criteria will be applied to the comparator group, which will include new users of DPP-4 inhibitors.
研究组 & 干预措施
subjects with Type 2 Diabetes mellitus
干预措施: Empagliflozin (Drug)
subjects with Type 2 Diabetes mellitus
干预措施: Dipeptidyl-peptidase 4 (DPP-4) inhibitors (Drug)
结局指标
主要结局
Number of Participants With Ketoacidosis
时间窗: Up to 12 months after the index date (defined as the date on which each identified new user received the index prescription for Empagliflozin or DPP-4 inhibitor).
Ketoacidosis is defined as a serious complication of diabetes characterized by high levels of ketones in the body due to lack of insulin and low food intake.
Number of Participants With Severe Urinary Tract Infections (UTIs)
时间窗: Up to 12 months after index date (defined as the date on which each identified new user received the index prescription for Empagliflozin or DPP-4 inhibitor).
Severe UTIs is defined as pyelonephritis or urosepsis.
Number of Participants With Volume Depletion
时间窗: Up to 12 months after index date (defined as the date on which each identified new user received the index prescription for Empagliflozin or DPP-4 inhibitor).
Volume depletion is defined as the reduction in the extracellular fluids.
Number of Participants With Dehydration
时间窗: Up to 12 months after index date (defined as the date on which each identified new user received the index prescription for Empagliflozin or DPP-4 inhibitor).
Dehydration is defined as the loss of total body water that leads to hypertonicity.
次要结局
- Number of Participants With Ketoacidosis During Ramadan Periods(Up to day 29.)
- Number of Participants With Dehydration During Ramadan Periods(Up to day 29.)
- Number of Participants With Severe Urinary Tract Infections (UTIs) During Ramadan Periods(Up to day 29.)
- Number of Participants With Volume Depletion During Ramadan Periods(Up to day 29.)