DiabetesPhase 3NCT00322257

Safety and Efficacy of Inhaled Insulin in Type 1 Diabetes

A Phase 3 study testing inhaled human insulin, insulin detemir and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 96 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

This trial is conducted in the United States of America (USA) and Canada. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 1
What is being tested?: inhaled human insulin, insulin detemir and insulin aspart
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 596 participants
Where: 96 sitesin 2 countries
Study dates: 1 May 2006to 2 Apr 2008
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 1 diabetes
HbA1c less than or equal to 11%
Body mass index (BMI) less than or equal to 40.0 kg/m2

Who cannot join

Total daily insulin dosage more than 100 IU or U/day.
Current smoking or smoking within the last 6 months
Impaired hepatic or renal function
Cardiac problems
Uncontrolled hypertension
Current proliferative retinopathy or maculopathy requiring acute treatment

Trial locations and contacts

96 sites in 2 countries.

Country

City, postcode or hospital

96 sites in 2 countries

United States86 sites

Novo Nordisk Investigational Site
Albany, New York, 12206
Novo Nordisk Investigational Site
Asheville, North Carolina, 28803
Novo Nordisk Investigational Site
Athens, Georgia, 30606
Novo Nordisk Investigational Site
Atlanta, Georgia, 30318
Novo Nordisk Investigational Site
Aurora, Colorado, 80045
Novo Nordisk Investigational Site
Baton Rouge, Louisiana, 70808
Novo Nordisk Investigational Site
Birmingham, Alabama, 35294
Novo Nordisk Investigational Site
Bloomington, Minnesota, 55420
Novo Nordisk Investigational Site
Boca Raton, Florida, 33433
Novo Nordisk Investigational Site
Butte, Montana, 59701
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37404
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37411
Novo Nordisk Investigational Site
Chicago, Illinois, 60607
Novo Nordisk Investigational Site
Cincinnati, Ohio, 45267
Novo Nordisk Investigational Site
Cleveland, Ohio, 44122
Novo Nordisk Investigational Site
Colorado Springs, Colorado, 80909
Novo Nordisk Investigational Site
Concord, California, 94520
Novo Nordisk Investigational Site
Dallas, Texas, 75230
Novo Nordisk Investigational Site
Dallas, Texas, 75231
Novo Nordisk Investigational Site
Dallas, Texas, 75246
Novo Nordisk Investigational Site
Dallas, Texas, 75390-8858
Novo Nordisk Investigational Site
Dayton, Ohio, 45406
Novo Nordisk Investigational Site
Des Moines, Iowa, 50314
Novo Nordisk Investigational Site
Dover, New Hampshire, 03820
Novo Nordisk Investigational Site
Duluth, Minnesota, 55805
Novo Nordisk Investigational Site
Encino, California, 91436
Novo Nordisk Investigational Site
Escondido, California, 92025
Novo Nordisk Investigational Site
Fresno, California, 93720
Novo Nordisk Investigational Site
Greenville, North Carolina, 27834
Novo Nordisk Investigational Site
Hampton, New Hampshire, 03842
Novo Nordisk Investigational Site
Hershey, Pennsylvania, 17033
Novo Nordisk Investigational Site
Hollywood, Florida, 33021
Novo Nordisk Investigational Site
Honolulu, Hawaii, 96813
Novo Nordisk Investigational Site
Honolulu, Hawaii, 96814
Novo Nordisk Investigational Site
Hyattsville, Maryland, 20782
Novo Nordisk Investigational Site
Idaho Falls, Idaho, 83404-7596
Novo Nordisk Investigational Site
Inglewood, California, 90301
Novo Nordisk Investigational Site
Jefferson City, Missouri, 65109
Novo Nordisk Investigational Site
Kansas City, Missouri, 64114
Novo Nordisk Investigational Site
Kettering, Ohio, 45429
Novo Nordisk Investigational Site
La Jolla, California, 92037
Novo Nordisk Investigational Site
Lafayette, Indiana, 47904
Novo Nordisk Investigational Site
Lake Mary, Florida, 32746
Novo Nordisk Investigational Site
Lawrenceville, New Jersey, 08648
Novo Nordisk Investigational Site
Lexington, Kentucky, 40503
Novo Nordisk Investigational Site
Medford, Oregon, 97504
Novo Nordisk Investigational Site
Melbourne, Florida, 32901
Novo Nordisk Investigational Site
Mentor, Ohio, 44060
Novo Nordisk Investigational Site
Merritt Island, Florida, 32953
Novo Nordisk Investigational Site
Miami, Florida, 33136
Novo Nordisk Investigational Site
Midland, Texas, 79707
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, 53209
Novo Nordisk Investigational Site
Minneapolis, Minnesota, 55416-2699
Novo Nordisk Investigational Site
Mission Viejo, California, 92691
Novo Nordisk Investigational Site
New Albany, Indiana, 47150
Novo Nordisk Investigational Site
New Britain, Connecticut, 06050
Novo Nordisk Investigational Site
New Hyde Park, New York, 11042
Novo Nordisk Investigational Site
Norristown, Pennsylvania, 19401
Novo Nordisk Investigational Site
Norwalk, Connecticut, 06851
Novo Nordisk Investigational Site
Ogden, Utah, 84403
Novo Nordisk Investigational Site
Olympia, Washington, 98502
Novo Nordisk Investigational Site
Omaha, Nebraska, 68114
Novo Nordisk Investigational Site
Peoria, Illinois, 61615
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19107
Novo Nordisk Investigational Site
Poway, California, 92064
Novo Nordisk Investigational Site
Renton, Washington, 98057
Novo Nordisk Investigational Site
Rochester, New York, 14642
Novo Nordisk Investigational Site
San Antonio, Texas, 78229
Novo Nordisk Investigational Site
San Mateo, California, 94401
Novo Nordisk Investigational Site
Santa Barbara, California, 93105
Novo Nordisk Investigational Site
Savannah, Georgia, 31406
Novo Nordisk Investigational Site
Scarborough, Maine, 04074
Novo Nordisk Investigational Site
Shawnee Mission, Kansas, 66204
Novo Nordisk Investigational Site
Spokane, Washington, 99208
Novo Nordisk Investigational Site
Springfield, Illinois, 62711
Novo Nordisk Investigational Site
Springfield, Massachusetts, 01199
Novo Nordisk Investigational Site
St Louis, Missouri, 63141
Novo Nordisk Investigational Site
Topeka, Kansas, 66606
Novo Nordisk Investigational Site
Tupelo, Mississippi, 38801
Novo Nordisk Investigational Site
Tuscaloosa, Alabama, 35406
Novo Nordisk Investigational Site
Tustin, California, 92780
Novo Nordisk Investigational Site
Vista, California, 92084
Novo Nordisk Investigational Site
Walnut Creek, California, 94598
Novo Nordisk Investigational Site
Waltham, Massachusetts, 02453
Novo Nordisk Investigational Site
Waterbury, Connecticut, 06708
Novo Nordisk Investigational Site
West Palm Beach, Florida, 33401

Other trials in United States

Canada10 sites

Novo Nordisk Investigational Site
Gatineau, J8T 8M1
Novo Nordisk Investigational Site
Laval, Quebec, H7T 2P5
Novo Nordisk Investigational Site
Mississauga, L5M 2V8
Novo Nordisk Investigational Site
Montreal, Quebec, H2W 1T8
Novo Nordisk Investigational Site
Penticton, V2A 5C8
Novo Nordisk Investigational Site
Red Deer, T4N 6V7
Novo Nordisk Investigational Site
St. John's, A1B 3V6
Novo Nordisk Investigational Site
Vancouver, V5Z 1C6
Novo Nordisk Investigational Site
Victoria, British Columbia, V8R 1J8
Novo Nordisk Investigational Site
Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

About this study

Official title: Inhaled Mealtime Insulin With the AERx® iDMS Versus Subcutaneous Injected Insulin Aspart Both in Combination With Insulin Detemir in Type 1 Diabetes: A 104 Week, Open-Label, Multicenter, Randomised, Parallel Trial (Followed by a Twelve-Week Re-Randomised Extension) To Investigate Safety and Efficacy

Read the 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.

Conditions: Diabetes, Diabetes Mellitus, Type 1
Being tested: inhaled human insulin, insulin detemir, insulin aspart
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

inhaled human insulinDrug
Treat-to-target dose titration scheme, inhalation.
insulin detemirDrug
Also called Levemir, NN304
Injection s.c., 50% of daily dose
insulin aspartDrug
Treat-to-target dose titration scheme, injection s.c.

Study groups in NCT00322257
Study group	Role	What they receive
A	Experimental	Not described Receives: Drug: inhaled human insulin; Drug: insulin detemir
B	Active comparator	Not described Receives: Drug: insulin detemir; Drug: insulin aspart

What is being measured

The primary outcome is the main question the study is designed to answer.

HbA1c
Measured: After 52 weeks

Secondary outcomes (6)

Body weight
Measured: after 52 weeks
Antibodies
Measured: after 52 weeks
Hypoglycemia
Measured: For the duration of the trial
Insulin doses
Measured: For the duration of the trial
Pulmonary Function
Measured: For the duration of the trial
Fasting plasma glucose
Measured: after 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 20062 Apr 2008

First posted5 May 2006 (estimated)
Study start1 May 2006
Primary completion2 Apr 2008
Study completion2 Apr 2008

Why it stopped: See termination reason in detailed description

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 596 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00322257
Sponsor's protocol ID: NN1998-2076
Status last verified: Sep 2018
First submitted: 3 May 2006
Last updated: 5 Sep 2018
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
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Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
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All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Inhaled Mealtime Insulin With the AERx® iDMS Versus Subcutaneous Injected Insulin Aspart Both in Combination With Insulin Detemir in Type 1 Diabetes: A 104 Week, Open-Label, Multicenter, Randomised, Parallel Trial (Followed by a Twelve-Week Re-Randomised Extension) To Investigate Safety and Efficacy
ClinicalTrials.gov ID: NCT00322257
Acronym / sponsor ID: NN1998-2076
Conditions: Diabetes, Diabetes Mellitus, Type 1
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: See termination reason in detailed description
Enrolment: 596 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 1 May 2006 (actual)
Primary completion: 2 Apr 2008 (actual)
Study completion: 2 Apr 2008 (actual)
First posted: 5 May 2006 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
A	Experimental	Drug: inhaled human insulin, Drug: insulin detemir
B	Active comparator	Drug: insulin detemir, Drug: insulin aspart

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Type 1 diabetes
HbA1c less than or equal to 11%
Body mass index (BMI) less than or equal to 40.0 kg/m2

Key exclusion criteria (6 listed)

Total daily insulin dosage more than 100 IU or U/day.
Current smoking or smoking within the last 6 months
Impaired hepatic or renal function
Cardiac problems
Uncontrolled hypertension

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
inhaled human insulinTreat-to-target dose titration scheme, inhalation.	Drug	A
insulin detemirAlso: Levemir, NN304Injection s.c., 50% of daily dose	Drug	A, B
insulin aspartTreat-to-target dose titration scheme, injection s.c.	Drug	B

Primary outcome

HbA1c
Time frame: After 52 weeks

6 secondary outcomes

Body weight
Time frame: after 52 weeks
Antibodies
Time frame: after 52 weeks
Hypoglycemia
Time frame: For the duration of the trial
Insulin doses
Time frame: For the duration of the trial
Pulmonary Function
Time frame: For the duration of the trial
Fasting plasma glucose
Time frame: after 52 weeks

Results and safety

The study was stopped early (reason given: See termination reason in detailed description). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
Clinical Trials at Novo NordiskLink provided by the sponsor.

Related trials for Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Registry (GCR, 1452) study director

Novo Nordisk A/S

96 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing inhaled human insulin, insulin detemir and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 96 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 96 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: See termination reason in detailed description). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: After 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00322257.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.