CTRI/2018/02/012158尚未招募未知
A 12â??month prospective observational study assessing the real-world clinical effectiveness, safety and health-economic benefits of Toujeo® initiation after oral antidiabetic drug failure in insulin-naïve patients with type 2 diabetes mellitus - ATOS
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
- •1. Signed patient informed consent;
- •2. Type 2 diabetes mellitus;
- •3. Treated with at least 1 OAD for at least 6 months;
- •4. Legal age of adulthood, but at least >=18 years;
- •5. HbA1c >7.0 % and <=11% within 3 months of study baseline;
- •6. Physiciansâ?? decision in accordance with the current local guidelines to add basal insulin glargine U300 to an existing OAD regimen
排除标准
- •1. Diabetes mellitus other than type 2;
- •2. Existing or previous treatment with insulin or other injectable antidiabetic drugs. The
- •following is allowed:
- •- Previous short-term insulin treatment due to an intercurrent medical condition,
- •with treatment duration not exceeding 10 concurrent days in the past year;
- •- Previous insulin treatment of gestational diabetes, if the patient has discontinued
- •insulin treatment more than a year ago.
- •3. Contraindication to insulin glargine U300 according to local product labelling;
- •4. Pregnancy, breastfeeding or pregnancy planned during the course of the study;
- •5. Drug or alcohol abuse within the past year;
- •6. Concomitant disease with life expectancy of less than 1 year;
- •7. Concomitant participation in a clinical trial
研究者
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