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

Phase 3TerminatedNCT00472953

Novo Nordisk A/S38 enrolled

Overview

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).

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 Chronic Obstructive Pulmonary Disease

Interventions

inhaled human insulinDRUG

Treat-to-target dose titration scheme, pre-prandial, inhalation.

insulin aspartDRUG

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

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

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

Locations (27)

Novo Nordisk Investigational Site

Outcomes

Primary Outcomes

To evaluate pulmonary safety comparing inhaled insulin to subcutaneous injections

Time frame: After one year

Secondary Outcomes

Patient Reported Outcomes

Time frame: After one year

Diabetes control measured by change in HbA1c from baseline

Time frame: After one year

Preprandial Insulin Doses

Time frame: After one year

Data from ClinicalTrials.gov

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