Safety of Inhaled Preprandial Human Insulin in Subjects With Diabetes and Asthma (iINHALE 9)

Novo Nordisk

Status and phase: Terminated; Phase 3

Conditions: Diabetes Mellitus, Type 1; Asthma; Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: inhaled human insulin; Drug: insulin aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT00523042

NN1998-1616

Details and patient eligibility

About

This trial is conducted in Europe, Asia, Oceania and the United States of America (USA).

This is a one-year clinical trial to compare the safety of inhaled preprandial human insulin to subcutaneous insulin aspart in subjects with type 1 or 2 diabetes and asthma.

Full description

The decision to discontinue the development of AERx® is not due to any safety concerns. An analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 or type 2 diabetes
• Treatment with insulin and/or oral anti-diabetic drugs
• Asthma for at least 6 months
• Positive airway reversibility/bronchoprovocation test or documented positive test in the last 3 years
• HbA1C less than or equal to 11.0 %
• Body Mass Index (BMI) less than or equal to 40.0 kg/m2

Exclusion criteria

• Current smoking or smoking within the last 6 months
• Other current acute or chronic pulmonary disease excluding asthma
• Recurrent severe hypoglycaemia
• Proliferative retinopathy or maculopathy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: inhaled human insulin

B

Active Comparator group

Treatment:

Drug: insulin aspart