Safety of Inhaled Human Insulin in Subjects With Diabetes Mellitus and Chronic Obstructive Pulmonary Disease (COPD) (iINHALE 8)

Novo Nordisk

Status and phase: Terminated; Phase 3

Conditions: Diabetes Mellitus, Type 1; Diabetes; Chronic Obstructive Pulmonary Disease; Diabetes Mellitus, Type 2

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00472953

NN1998-1617

2006-004731-29 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted in Europe, Asia and South America. A one-year clinical trial to compare the safety of inhaled human insulin to subcutaneous insulin aspart in subjects with type 1 or type 2 diabetes and chronic obstructive pulmonary disease (COPD).

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: 38 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic Obstructive Pulmonary Disease
• Type 1 or type 2 diabetes
• HbA1c lower or equal to 11.0 %
• Body Mass Index (BMI) lower or equal to 40.0 kg/m2

Exclusion criteria

• Recurrent severe hypoglycaemia
• Current smoking or smoking within the last 6 months
• Other pulmonary disease including asthma
• Proliferative retinopathy or maculopathy requiring acute treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: inhaled human insulin

B

Active Comparator group

Treatment:

Drug: insulin aspart