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NCT00472953 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

— iINHALE 8  

Official title:
Inhaled Pre-prandial Human Insulin Versus Subcutaneous Injected Insulin Aspart in Subjects With Diabetes and Chronic Obstructive Pulmonary Disease: A 52-week Open Label, Multicentre, Randomized, Parallel Trial to Investigate Long-term Safety

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00472953
Other study ID # NN1998-1617
Secondary ID 2006-004731-29
Status Terminated
Phase Phase 3
First received May 11, 2007
Last updated February 28, 2017
Start date May 15, 2007
Est. completion date March 5, 2008

Study information
Verified date February 2017
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 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).

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 38
Est. completion date March 5, 2008
Est. primary completion date March 5, 2008
Accepts healthy volunteers No
Gender All
Age group 30 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Argentina Novo Nordisk Investigational Site Buenos Aires
Argentina Novo Nordisk Investigational Site Buenos Aires
Argentina Novo Nordisk Investigational Site Ciudad de Buenos Aires
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
Romania Novo Nordisk Investigational Site Bucharest
Romania Novo Nordisk Investigational Site Bucharest
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
Taiwan Novo Nordisk Investigational Site Changhua
Taiwan Novo Nordisk Investigational Site Chiayi City
Taiwan Novo Nordisk Investigational Site Taipei
Thailand Novo Nordisk Investigational Site Bangkok
Thailand Novo Nordisk Investigational Site Bangkok
Turkey Novo Nordisk Investigational Site Erzurum
Turkey Novo Nordisk Investigational Site Gaziantep
Turkey Novo Nordisk Investigational Site Istanbul
Turkey Novo Nordisk Investigational Site Istanbul
Turkey Novo Nordisk Investigational Site Istanbul
Turkey Novo Nordisk Investigational Site Kocaeli

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

Countries where clinical trial is conducted

Argentina,  India,  Romania,  Slovakia,  Taiwan,  Thailand,  Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate pulmonary safety comparing inhaled insulin to subcutaneous injections After one year
Secondary Patient Reported Outcomes After one year
Secondary Diabetes control measured by change in HbA1c from baseline After one year
Secondary Preprandial Insulin Doses After one year
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