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NCT00523042 Clinical Trial

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

Asthma Clinical Trial

— iINHALE 9  

Official title:
Inhaled Preprandial Human Insulin With the AERx® iMS Versus Subcutaneous Injected Insulin Aspart in Subjects With Diabetes and Asthma: A 52-week, Open-label, Multinational, Randomised, Parallel Trial to Investigate Long-term Safety

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00523042
Other study ID # NN1998-1616
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date August 30, 2007
Est. completion date February 28, 2008

Study information
Verified date September 2018
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 10
Est. completion date February 28, 2008
Est. primary completion date February 28, 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• insulin aspart
Treat-to-target dose titration scheme, injection s.c.
• inhaled human insulin
Treat-to-target dose titration scheme, inhalation.

Locations
Country Name City State
Australia Novo Nordisk Investigational Site Auchenflower
Australia Novo Nordisk Investigational Site Box Hill Victoria
Australia Novo Nordisk Investigational Site Broadmeadow New South Wales
Australia Novo Nordisk Investigational Site Camperdown New South Wales
Australia Novo Nordisk Investigational Site East Ringwood Victoria
Australia Novo Nordisk Investigational Site Keswick South Australia
Australia Novo Nordisk Investigational Site Kippa Ring
Australia Novo Nordisk Investigational Site Parkville Victoria
Former Serbia and Montenegro Novo Nordisk Investigational Site Belgrade
India Novo Nordisk Investigational Site Chandigarh Punjab
India Novo Nordisk Investigational Site Hyderabad
India Novo Nordisk Investigational Site Kolkata West Bengal
India Novo Nordisk Investigational Site Mumbai
India Novo Nordisk Investigational Site Pune
India Novo Nordisk Investigational Site Vellore Tamil Nadu
Malaysia Novo Nordisk Investigational Site Cheras
Malaysia Novo Nordisk Investigational Site Kota Bharu, Kelantan
Malaysia Novo Nordisk Investigational Site Pulau Pinang
Slovakia Novo Nordisk Investigational Site Kosice
Slovakia Novo Nordisk Investigational Site Lubochna
Slovakia Novo Nordisk Investigational Site Moldava nad Bodvou
Slovakia Novo Nordisk Investigational Site Zilina
Slovakia Novo Nordisk Investigational Site Zilina
United States Novo Nordisk Investigational Site Columbus Ohio
United States Novo Nordisk Investigational Site Fresno California
United States Novo Nordisk Investigational Site Houston Texas
United States Novo Nordisk Investigational Site Kansas City Missouri
United States Novo Nordisk Investigational Site New Orleans Louisiana
United States Novo Nordisk Investigational Site Ogden Utah
United States Novo Nordisk Investigational Site Philadelphia Pennsylvania
United States Novo Nordisk Investigational Site Pittsburgh Pennsylvania
United States Novo Nordisk Investigational Site Spokane Washington

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Australia,  Former Serbia and Montenegro,  India,  Malaysia,  Slovakia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in lung function, chest X-rays, or asthma exacerbation frequency after 52 weeks of treatment
Secondary Diabetes control measured by change in HbA1c from baseline to end of treatment
Secondary Laboratory assessments (biochemistry, insulin antibodies, blood count) from baseline to end of treatment
Secondary Preprandial insulin doses for the duration of the trial
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