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

NCT ID: NCT00472953

Last Updated: 2017-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-15

Study Completion Date

2008-03-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Group Type EXPERIMENTAL

inhaled human insulin

Intervention Type DRUG

Treat-to-target dose titration scheme, pre-prandial, inhalation.

B

Group Type ACTIVE_COMPARATOR

insulin aspart

Intervention Type DRUG

Treat-to-target dose titration scheme, pre-prandial, injection s.c.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

inhaled human insulin

Treat-to-target dose titration scheme, pre-prandial, inhalation.

Intervention Type DRUG

insulin aspart

Treat-to-target dose titration scheme, pre-prandial, injection s.c.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novo Nordisk Investigational Site

Buenos Aires, , Argentina

Site Status

Novo Nordisk Investigational Site

Buenos Aires, , Argentina

Site Status

Novo Nordisk Investigational Site

Ciudad de Buenos Aires, , Argentina

Site Status

Novo Nordisk Investigational Site

Chandigarh, Punjab, India

Site Status

Novo Nordisk Investigational Site

Vellore, Tamil Nadu, India

Site Status

Novo Nordisk Investigational Site

Kolkata, West Bengal, India

Site Status

Novo Nordisk Investigational Site

Hyderabad, , India

Site Status

Novo Nordisk Investigational Site

Mumbai, , India

Site Status

Novo Nordisk Investigational Site

Pune, , India

Site Status

Novo Nordisk Investigational Site

Bucharest, , Romania

Site Status

Novo Nordisk Investigational Site

Bucharest, , Romania

Site Status

Novo Nordisk Investigational Site

Košice, , Slovakia

Site Status

Novo Nordisk Investigational Site

Ľubochňa, , Slovakia

Site Status

Novo Nordisk Investigational Site

Moldava nad Bodvou, , Slovakia

Site Status

Novo Nordisk Investigational Site

Žilina, , Slovakia

Site Status

Novo Nordisk Investigational Site

Žilina, , Slovakia

Site Status

Novo Nordisk Investigational Site

Changhua, , Taiwan

Site Status

Novo Nordisk Investigational Site

Chiayi City, , Taiwan

Site Status

Novo Nordisk Investigational Site

Taipei, , Taiwan

Site Status

Novo Nordisk Investigational Site

Bangkok, , Thailand

Site Status

Novo Nordisk Investigational Site

Bangkok, , Thailand

Site Status

Novo Nordisk Investigational Site

Erzurum, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Gaziantep, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Kocaeli, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Argentina India Romania Slovakia Taiwan Thailand Turkey (Türkiye)

Related Links

Access external resources that provide additional context or updates about the study.

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2006-004731-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN1998-1617

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.