CTRI/2019/02/017636尚未招募未知
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 - ORIO
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
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 physicianâ??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 U300.
- •- 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.
研究者
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