A multicenter, multinational, prospective, observational study to describe the clinical outcomes in patients with type 2 diabetes mellitus, treated with insulin glargine 300 U/mL (insulin glargine U300 before, during and after the period of Ramadan
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 516
- 试验地点
- 10
- 主要终点
- To assess the percentage of patients experiencing at least 1 episode of severe and/or symptomatic documented hypoglycemia with plasma glucose (PG) ≤70 mg/dL (3.9 mmol/L) during the Pre-Ramadan, Ramadan, and Post-Ramadan periods.
研究概览
简要总结
A multicenter, multinational, prospective,observational study to describe the clinical outcomes in patients with type 2diabetes mellitus, treated with insulin glargine 300 U/mL (insulin glargineU300) before, during and after the period of Ramadan. A patient‘s diary will be provided tothe patients in order to collect their SMPG values, as recommended by the physician, insulin doses and to report anyepisode of symptomatic hypoglycemia andother health problems, information on days without fasting
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient with T2DM treated with insulin glargine U300, as basal insulin for at least 8 weeks prior to inclusion in the study, and who plans to continue to be on insulin glargine U300, during the period of Ramadan.
- •Patient who intends to fast for at least 15 days during Ramadan.
- •Patient willing to sign written informed consent.
- •Patient able and willing to perform SMPG according to physician instruction.
- •Patient willing to complete study patient diary (for SMPG, insulin dose, and hypoglycemia) according to physician’s recommendation.
排除标准
- •Age <18 years old or.
- •Pregnant or Breastfeeding women.
- •Diabetes other than T2DM.
- •Treatment with basal bolus or premix regimen, in the 6 months prior to start of treatment with insulin glargine U
- •Use of any investigational drug within 1 month or 5 half-lives, whichever is longer, prior to selection visit.
- •Known hypersensitivity/intolerance to insulin glargine U300 or any of its excipients.
结局指标
主要结局
To assess the percentage of patients experiencing at least 1 episode of severe and/or symptomatic documented hypoglycemia with plasma glucose (PG) ≤70 mg/dL (3.9 mmol/L) during the Pre-Ramadan, Ramadan, and Post-Ramadan periods.
时间窗: 5 months including one month of fasting in Ramadan
次要结局
- To assess the incidence (percentage of patients with event) and event rate (frequency of occurrence) of symptomatic hypoglycemic episodes during the Pre-Ramadan, Ramadan, and Post-Ramadan periods.(To describe glycemic control parameters.)