Safety of Inhaled Human Insulin in Subjects With Diabetes... | NCT00472953

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

NCT00472953

Sponsor

Novo Nordisk A/S

Status

Terminated

Last Update Posted

Mar 1, 2017Actual

Enrollment

38Actual

Phase

Phase 3

Conditions

Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Chronic Obstructive Pulmonary Disease

Interventions

inhaled human insulin
insulin aspart

Countries

Argentina
India
Romania
Slovakia
Taiwan
Thailand
Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2006-004731-29	EudraCT Number

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

See termination reason in detailed description

Expanded Access Info

Start Date

May 15, 2007Actual

Primary Completion Date

Mar 5, 2008Actual

Completion Date

Mar 5, 2008Actual

First Submitted Date

May 11, 2007

First Submission Date that Met QC Criteria

May 11, 2007

First Posted Date

May 14, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2017

Last Update Posted Date

Mar 1, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 (COPD).

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental		Drug: inhaled human insulin
B	Active Comparator		Drug: insulin aspart

Interventions

Name	Type	Description	Arm Group Labels	Other Names
inhaled human insulin	Drug	Treat-to-target dose titration scheme, pre-prandial, inhalation.	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate pulmonary safety comparing inhaled insulin to subcutaneous injections		After one year

Secondary Outcomes

Measure	Description	Time Frame
Patient Reported Outcomes		After one year
Diabetes control measured by change in HbA1c from baseline		After one year
Preprandial Insulin Doses

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Buenos Aires		B1636DSU	Argentina
Novo Nordisk Investigational Site

Label	URL
Clinical Trials at Novo Nordisk	View source

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D003922	Diabetes Mellitus, Type 1
D003924	Diabetes Mellitus, Type 2
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D061266	Insulin, Short-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins