CTRI/2026/03/105377招募中Unknown
A post-marketing active surveillance of insulin human inhalational powder in adult patients with diabetes mellitus
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- Cipla Ltd
- 入组人数
- 500
- 试验地点
- 10
研究概览
简要总结
Diabetes as a metabolic disease has reached epidemic proportions in India. Inhaled insulin is one of the promising non-invasive candidates to address concerns with current treatment options. This is an open label, prospective, non-comparative, multicentre, post-marketing active surveillance in diabetes mellitus on the use of inhaled insulin for 6 months. Patients who are prescribed Afrezza*®* (Insulin human Inhalational Powder) as per prescribing information will be enrolled as per eligibility criteria in this surveillance. Safety and tolerability will be evaluated by recording adverse events during follow-up period of 6 months from the available data.
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
- •Patients willing to sign data sharing consent before performing any procedures.
- •Patients of 18 years and above with diabetes mellitus who are prescribed Insulin human inhalation powder with inhaler as per prescribing information.
排除标准
- •Known hypersensitivity to insulin or to any of the excipients.
- •Known history of bronchospasm
- •Known case of Chronic lung disease such as asthma or chronic obstructive pulmonary disease
- •History of Diabetic Ketoacidosis in last 12 months
- •Patients who smoke or who have recently stopped smoking (less than 6 months)
- •Patients unsuitable to participate as per Investigator’s discretion.
- •Female who is pregnant.
研究者
Dr Jaideep Gogtay
Cipla Ltd
研究点 (10)
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