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临床试验/CTRI/2026/03/105377
CTRI/2026/03/105377招募中Unknown

A post-marketing active surveillance of insulin human inhalational powder in adult patients with diabetes mellitus

Cipla Ltd10 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2026年4月1日最近更新:

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

发起方
Cipla Ltd
申办方类型
Pharmaceutical industry-Indian
责任方
Principal Investigator
主要研究者

Dr Jaideep Gogtay

Cipla Ltd

研究点 (10)

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