Health Condition 1: E139- Other specified diabetes mellituswithout complications
Conditions
Interventions
Intervention1: Afrezza Insulin human inhalation powder 4U/ 8U/ 12U per cartridge with inhaler: Insulin human inhalation powder (r DNA origin) for oral inhalation use
Control Intervention1: NIL: NIL
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients willing to sign data sharing consent before performing any procedures. 2. Patients of 18 years and above with diabetes mellitus who are prescribed Insulin human inhalation powder with inhaler as per prescribing information
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to insulin or to any of the excipients. 2. Known history of bronchospasm 3. Known case of Chronic lung disease such as asthma or chronic obstructive pulmonary disease 4. History of Diabetic Ketoacidosis in last 12 months 5. Patients who smoke or who have recently stopped smoking (less than 6 months) 6. Patients unsuitable to participate as per Investigator s discretion. 7. Female who is pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events Incidence of Serious Adverse EventsTimepoint: 3 months or Day 90 6 months or Day 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactRahul Namjoshi
Cipla Ltd
Outcome results
None listed