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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

May 11, 2007

Last Updated Date

January 14, 2009

Start Date ^†

May 2007

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00472953 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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

Brief 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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Condition ^†

Chronic Obstructive Pulmonary Disease (COPD)
Diabetes Mellitus

Intervention ^†

Drug: inhaled pre-prandial human insulin
Drug: insulin aspart

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Terminated

Enrollment ^†

Completion Date

March 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

30 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

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

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00472953

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Secondary IDs ^††

EudraCT No: 2006-004731-29

Study Sponsor ^†

Novo Nordisk

Collaborators ^††

Investigators ^†

Study Director:

Else Munksgaard

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

January 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.