DiabetesPhase 3NCT00411892

Effect of Inhaled Insulin (AERx® iDMS) on Blood Glucose Control in Type 2 Diabetes

A Phase 3 study testing pioglitazone and inhaled human insulin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 110 sites in United States.

Terminated

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

Official record

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Trial summary

This trial is conducted in the United States of America (USA). This trial will compare the changes in HbA1c after 26 weeks of inhaled insulin and pioglitazone combination therapy versus pioglitazone treatment alone. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 2
What is being tested?: pioglitazone and inhaled human insulin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 196 participants
Where: 110 sitesUnited States
Study dates: 29 Nov 2006to 18 Mar 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 2 diabetes
Current treatment with oral antidiabetes drugs (OADs) for at least 2 months
HbA1c between 7.0-11.0% if on OAD monotherapy
HbA1c between 7.0-10.0% if on OAD combination therapy
BMI less than or equal to 40 kg/m2

Who cannot join

Current regular smoking or regular smoking within the last 6 months
Current acute or chronic pulmonary disease (except for asthma)
Proliferative retinopathy requiring treatment
Clinically significant disease history including kidney or liver disease, or heart disease which limits physical activity or results in discomfort with physical activity
Pregnancy

Trial locations and contacts

110 sites in 1 country.

City, postcode or hospital

110 sites in 1 country

United States110 sites

Novo Nordisk Investigational Site
Altoona, Pennsylvania, 16602
Novo Nordisk Investigational Site
Arlington, Texas, 76014
Novo Nordisk Investigational Site
Arlington, Virginia, 22204
Novo Nordisk Investigational Site
Arvada, Colorado, 80005
Novo Nordisk Investigational Site
Athens, Georgia, 30606
Novo Nordisk Investigational Site
Atlanta, Georgia, 30342
Novo Nordisk Investigational Site
Avon, Illinois, 46123
Novo Nordisk Investigational Site
Baltimore, Maryland, 21201
Novo Nordisk Investigational Site
Beaver, Pennsylvania, 15009
Novo Nordisk Investigational Site
Bensalem, Pennsylvania, 19020
Novo Nordisk Investigational Site
Bermuda Dunes, California, 92203
Novo Nordisk Investigational Site
Beverly Hills, Florida, 34465
Novo Nordisk Investigational Site
Billings, Montana, 59102
Novo Nordisk Investigational Site
Bismarck, North Dakota, 58501
Novo Nordisk Investigational Site
Bloomington, Minnesota, 55420
Novo Nordisk Investigational Site
Blue Ridge, Georgia, 30513
Novo Nordisk Investigational Site
Boca Raton, Florida, 33433
Novo Nordisk Investigational Site
Boise, Idaho, 83702
Novo Nordisk Investigational Site
Canal Fulton, Ohio, 44614
Novo Nordisk Investigational Site
Charlotte, North Carolina, 28209
Novo Nordisk Investigational Site
Chesterfield, Missouri, 63017
Novo Nordisk Investigational Site
Chicago, Illinois, 60607
Novo Nordisk Investigational Site
Chicago, Illinois, 60611
Novo Nordisk Investigational Site
Chicago, Illinois, 60612
Novo Nordisk Investigational Site
Cincinnati, Ohio, 45224
Novo Nordisk Investigational Site
Cincinnati, Ohio, 45245
Novo Nordisk Investigational Site
Clarksville, Tennessee, 37043
Novo Nordisk Investigational Site
Clearwater, Florida, 33759
Novo Nordisk Investigational Site
Cleveland, Ohio, 44115
Novo Nordisk Investigational Site
Cleveland, Ohio, 44122
Novo Nordisk Investigational Site
Clinton, Oklahoma, 73601
Novo Nordisk Investigational Site
Colorado Springs, Colorado, 80904
Novo Nordisk Investigational Site
Dallas, Texas, 75251
Novo Nordisk Investigational Site
Dayton, Ohio, 45439
Novo Nordisk Investigational Site
Des Moines, Iowa, 50314
Novo Nordisk Investigational Site
Dunwoody, Georgia, 30338
Novo Nordisk Investigational Site
Escondido, California, 92025
Novo Nordisk Investigational Site
Fresno, California, 93720
Novo Nordisk Investigational Site
Greer, South Carolina, 29651
Novo Nordisk Investigational Site
Hershey, Pennsylvania, 17033
Novo Nordisk Investigational Site
Hialeah, Florida, 33010
Novo Nordisk Investigational Site
High Point, North Carolina, 27262
Novo Nordisk Investigational Site
Hollywood, Florida, 33021
Novo Nordisk Investigational Site
Honolulu, Hawaii, 96814
Novo Nordisk Investigational Site
Houston, Texas, 77024
Novo Nordisk Investigational Site
Houston, Texas, 77030
Novo Nordisk Investigational Site
Huntington Beach, California, 92646
Novo Nordisk Investigational Site
Jackson, Mississippi, 39216
Novo Nordisk Investigational Site
Jefferson City, Missouri, 65109
Novo Nordisk Investigational Site
Kansas City, Missouri, 64111
Novo Nordisk Investigational Site
Kingsport, Tennessee, 37660
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
Las Vegas, Nevada, 89109
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89128
Novo Nordisk Investigational Site
Lewisville, Texas, 75067
Novo Nordisk Investigational Site
Lexington, Kentucky, 40503
Novo Nordisk Investigational Site
Little Rock, Arkansas, 72204
Novo Nordisk Investigational Site
Marianna, Florida, 32446
Novo Nordisk Investigational Site
Marlborough, Massachusetts, 01752
Novo Nordisk Investigational Site
Medford, Oregon, 97504-8491
Novo Nordisk Investigational Site
Melbourne, Florida, 32901
Novo Nordisk Investigational Site
Miami, Florida, 33136
Novo Nordisk Investigational Site
Niceville, Florida, 32578
Novo Nordisk Investigational Site
Norfolk, Virginia, 23502
Novo Nordisk Investigational Site
Norristown, Pennsylvania, 19401
Novo Nordisk Investigational Site
Northridge, California, 91325
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, 73104-5020
Novo Nordisk Investigational Site
Orange, California, 92868
Novo Nordisk Investigational Site
Orange, California, 92869
Novo Nordisk Investigational Site
Ozark, Alabama, 36360
Novo Nordisk Investigational Site
Palm Harbor, Florida, 34684
Novo Nordisk Investigational Site
Panama City, Florida, 32401
Novo Nordisk Investigational Site
Pembroke Pines, Florida, 33029
Novo Nordisk Investigational Site
Peoria, Illinois, 61615
Novo Nordisk Investigational Site
Plano, Texas, 75093
Novo Nordisk Investigational Site
Poway, California, 92064
Novo Nordisk Investigational Site
Powder Springs, Georgia, 30127
Novo Nordisk Investigational Site
Prince Frederick, Maryland, 20678
Novo Nordisk Investigational Site
Raleigh, North Carolina, 27612
Novo Nordisk Investigational Site
Richmond, Virginia, 23249
Novo Nordisk Investigational Site
Roseville, California, 95661
Novo Nordisk Investigational Site
Roswell, Georgia, 30076
Novo Nordisk Investigational Site
Sacramento, California, 95821
Novo Nordisk Investigational Site
San Antonio, Texas, 78229
Novo Nordisk Investigational Site
San Diego, California, 92103-620
Novo Nordisk Investigational Site
Sandy Springs, Georgia, 30328
Novo Nordisk Investigational Site
Santa Barbara, California, 93105
Novo Nordisk Investigational Site
St Louis, Missouri, 63141
Novo Nordisk Investigational Site
St. George, Utah, 84790
Novo Nordisk Investigational Site
St. Petersburg, Florida, 33709
Novo Nordisk Investigational Site
Suwanee, Georgia, 30024
Novo Nordisk Investigational Site
Syracuse, New York, 13210
Novo Nordisk Investigational Site
Tacoma, Washington, 98405
Novo Nordisk Investigational Site
Tallahassee, Florida, 32308
Novo Nordisk Investigational Site
Temecula, California, 92591
Novo Nordisk Investigational Site
Topeka, Kansas, 66606
Novo Nordisk Investigational Site
Tucker, Georgia, 30084
Novo Nordisk Investigational Site
Tucson, Arizona, 85741
Novo Nordisk Investigational Site
Tuscaloosa, Alabama, 35406
Novo Nordisk Investigational Site
Tustin, California, 92780
Novo Nordisk Investigational Site
Vero Beach, Florida, 32960
Novo Nordisk Investigational Site
Vestavia Hills, Alabama, 35209
Novo Nordisk Investigational Site
Walnut Creek, California, 94598
Novo Nordisk Investigational Site
Waltham, Massachusetts, 02453
Novo Nordisk Investigational Site
Warrenton, Virginia, 20186
Novo Nordisk Investigational Site
West Palm Beach, Florida, 33401
Novo Nordisk Investigational Site
Wichita, Kansas, 67205
Novo Nordisk Investigational Site
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: Effect of Inhaled Insulin (AERx® iDMS) Plus Pioglitazone Versus Pioglitazone Alone on HbA1c in Subjects With Type 2 Diabetes

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 2
Being tested: pioglitazone, inhaled human insulin
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

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

pioglitazoneDrug
Tablets, 45 mg/day.
inhaled human insulinDrug
Also called NN1998
Treat-to-target dose titration scheme, inhalation.

Study groups in NCT00411892
Study group	Role	What they receive
A	Experimental	Not described Receives: Drug: pioglitazone; Drug: inhaled human insulin
B	Active comparator	Not described Receives: Drug: pioglitazone

What is being measured

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

HbA1c change from baseline
Measured: After 26 weeks of treatment

Secondary outcomes (5)

Fasting plasma glucose
Measured: after 26 weeks of treatment
Lipid profiles
Measured: after 26 weeks of treatment
Frequency of hypoglycaemic episodes
Measured: after 26 weeks of treatment
Glucose profiles
Measured: at pre- and post meals, bedtime and 3:00 am
Change in body weight
Measured: after 26 weeks of treatment

Timeline

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

29 Nov 200618 Mar 2008

First posted15 Dec 2006 (estimated)
Study start29 Nov 2006
Primary completion18 Mar 2008
Study completion18 Mar 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: 196 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00411892
Sponsor's protocol ID: NN1998-1683
Status last verified: Sep 2018
First submitted: 14 Dec 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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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: Effect of Inhaled Insulin (AERx® iDMS) Plus Pioglitazone Versus Pioglitazone Alone on HbA1c in Subjects With Type 2 Diabetes
ClinicalTrials.gov ID: NCT00411892
Acronym / sponsor ID: NN1998-1683
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: See termination reason in detailed description
Enrolment: 196 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 29 Nov 2006 (actual)
Primary completion: 18 Mar 2008 (actual)
Study completion: 18 Mar 2008 (actual)
First posted: 15 Dec 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: pioglitazone, Drug: inhaled human insulin
B	Active comparator	Drug: pioglitazone

Who may qualify

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

Key inclusion criteria (5 listed)

Type 2 diabetes
Current treatment with oral antidiabetes drugs (OADs) for at least 2 months
HbA1c between 7.0-11.0% if on OAD monotherapy
HbA1c between 7.0-10.0% if on OAD combination therapy
BMI less than or equal to 40 kg/m2

Key exclusion criteria (5 listed)

Current regular smoking or regular smoking within the last 6 months
Current acute or chronic pulmonary disease (except for asthma)
Proliferative retinopathy requiring treatment
Clinically significant disease history including kidney or liver disease, or heart disease which limits physical activity or results in discomfort with physical activity
Pregnancy

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
pioglitazoneTablets, 45 mg/day.	Drug	A, B
inhaled human insulinAlso: NN1998Treat-to-target dose titration scheme, inhalation.	Drug	A

Primary outcome

HbA1c change from baseline
Time frame: After 26 weeks of treatment

5 secondary outcomes

Fasting plasma glucose
Time frame: after 26 weeks of treatment
Lipid profiles
Time frame: after 26 weeks of treatment
Frequency of hypoglycaemic episodes
Time frame: after 26 weeks of treatment
Glucose profiles
Time frame: at pre- and post meals, bedtime and 3:00 am
Change in body weight
Time frame: after 26 weeks of treatment

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

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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
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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

110 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pioglitazone and inhaled human insulin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 110 sites in United States.

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 5 inclusion and 5 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 110 sites in United States. 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 change from baseline (time frame: After 26 weeks of treatment). 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 NCT00411892.

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.