Safety of Inhaled Preprandial Human Insulin in Subjects With Diabetes and Asthma

Phase 3TerminatedNCT00523042

Novo Nordisk A/S10 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Asthma

Interventions

insulin aspartDRUG

Treat-to-target dose titration scheme, injection s.c.

inhaled human insulinDRUG

Treat-to-target dose titration scheme, inhalation.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (32)

Outcomes

Primary Outcomes

Changes in lung function, chest X-rays, or asthma exacerbation frequency

Time frame: after 52 weeks of treatment

Secondary Outcomes

Diabetes control measured by change in HbA1c

Time frame: from baseline to end of treatment

Laboratory assessments (biochemistry, insulin antibodies, blood count)

Time frame: from baseline to end of treatment

Preprandial insulin doses

Time frame: for the duration of the trial

Data from ClinicalTrials.gov

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