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

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00472953

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus Chronic Obstructive Pulmonary Disease (COPD)	Drug: inhaled pre-prandial human insulin Drug: insulin aspart	Phase III

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Diabetes

Drug Information available for: Insulin Insulin aspart

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
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

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

To evaluate pulmonary safety comparing inhaled insulin to subcutaneous injections [ Time Frame: after one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient Reported Outcomes [ Time Frame: after one year ] [ Designated as safety issue: No ]
Diabetes control measured by change in HbA1c from baseline [ Time Frame: after one year ] [ Designated as safety issue: No ]
Preprandial Insulin Doses [ Time Frame: after one year ] [ Designated as safety issue: No ]

Enrollment:	38
Study Start Date:	May 2007
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: inhaled pre-prandial human insulin Treat-to-target dose titration scheme, pre-prandial, inhalation.
B: Active Comparator	Drug: insulin aspart Treat-to-target dose titration scheme, pre-prandial, injection s.c.

Detailed 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.

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472953

Locations

Argentina

Buenos Aires, Argentina
India

Chandigargh, India, 160012
Romania

Bucharest, Romania
Slovakia

Lubochna, Slovakia
Taiwan

Taipei, Taiwan
Thailand

Bangkok, Thailand
Turkey

Istanbul, Turkey

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Else Munksgaard

Novo Nordisk

More Information

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN1998-1617, EudraCT No: 2006-004731-29
Study First Received:	May 11, 2007
Last Updated:	June 24, 2008
ClinicalTrials.gov Identifier:	NCT00472953
Health Authority:	Taiwan: Department of Health; Slovakia: State Institute for Drug Control; Turkey: Ministry of Health Drug and Pharmaceutical Department; Romania: National Medicines Agency; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia; Thailand: Ministry of Public Health; India: India's Drug Controller General, a division of the Ministry of

Study placed in the following topic categories:

Metabolic Diseases
Respiration Disorders
Diabetes Mellitus
Endocrine System Diseases
Insulin
Lung Diseases, Obstructive
Respiratory Tract Diseases

Lung Diseases
Insulin, Asp(B28)-
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009