DiabetesPhase 3NCT00427154

Effect of Inhaled Pre-prandial Human Insulin on Blood Glucose Control in Type 2 Diabetes

A Phase 3 study testing rosiglitazone, inhaled human insulin and metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 103 sites in United States.

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). This trial will compare the changes in HbA1c after 26 weeks of inhaled insulin or rosiglitazone treatment, both in combination with metformin and glimepiride. 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?: rosiglitazone, inhaled human insulin and metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 227 participants
Where: 103 sitesUnited States
Study dates: 10 Jan 2007to 11 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
Currently treated with antidiabetes drugs (including Exenatide) for at least 2 months
HbA1c between 7.5 and 11.0% (both inclusive) on antidiabetes combination therapy
BMI less than or equal to 40 kg/m2

Who cannot join

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

Trial locations and contacts

103 sites in 1 country.

City, postcode or hospital

103 sites in 1 country

United States103 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
Asheville, North Carolina, 28803
Novo Nordisk Investigational Site
Athens, Georgia, 30606
Novo Nordisk Investigational Site
Atlanta, Georgia, 30318
Novo Nordisk Investigational Site
Atlanta, Georgia, 30342
Novo Nordisk Investigational Site
Augusta, Georgia, 30912-3152
Novo Nordisk Investigational Site
Baltimore, Maryland, 21201
Novo Nordisk Investigational Site
Beaver, Pennsylvania, 15009
Novo Nordisk Investigational Site
Berlin, New Jersey, 08009
Novo Nordisk Investigational Site
Billings, Montana, 59101
Novo Nordisk Investigational Site
Boca Raton, Florida, 33433
Novo Nordisk Investigational Site
Boise, Idaho, 83702
Novo Nordisk Investigational Site
Charlotte, North Carolina, 28209
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37404
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37411
Novo Nordisk Investigational Site
Cherry Hill, New Jersey, 08034
Novo Nordisk Investigational Site
Chesterfield, Missouri, 63017
Novo Nordisk Investigational Site
Chicago, Illinois, 60607
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
Concord, California, 94520
Novo Nordisk Investigational Site
Dallas, Texas, 75230
Novo Nordisk Investigational Site
Dallas, Texas, 75231
Novo Nordisk Investigational Site
Dayton, Ohio, 45406
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
Greenville, North Carolina, 27834
Novo Nordisk Investigational Site
Greer, South Carolina, 29651
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, 77030
Novo Nordisk Investigational Site
Hueytown, Alabama, 35023
Novo Nordisk Investigational Site
Huntington Beach, California, 92646
Novo Nordisk Investigational Site
Hurst, Texas, 76054
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
Lawrenceville, New Jersey, 08648
Novo Nordisk Investigational Site
Lewisville, Texas, 75067
Novo Nordisk Investigational Site
Lexington, Kentucky, 40503
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
Merritt Island, Florida, 32953
Novo Nordisk Investigational Site
Miami, Florida, 33136
Novo Nordisk Investigational Site
Norfolk, Virginia, 23502
Novo Nordisk Investigational Site
Norristown, Pennsylvania, 19401
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, 73104-5020
Novo Nordisk Investigational Site
Omaha, Nebraska, 68114
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
Pembroke Pines, Florida, 33029
Novo Nordisk Investigational Site
Peoria, Illinois, 61615
Novo Nordisk Investigational Site
Poway, California, 92064
Novo Nordisk Investigational Site
Powder Springs, Georgia, 30127
Novo Nordisk Investigational Site
Renton, Washington, 98057
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
Novo Nordisk Investigational Site
Santa Barbara, California, 93105
Novo Nordisk Investigational Site
Scarborough, Maine, 04074
Novo Nordisk Investigational Site
Shawnee Mission, Kansas, 66204
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
Staten Island, New York, 10301
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
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
Vero Beach, Florida, 32960
Novo Nordisk Investigational Site
Vestavia Hills, Alabama, 35209
Novo Nordisk Investigational Site
Walnut Creek, California, 94598
Novo Nordisk Investigational Site
Warrenton, Virginia, 20186
Novo Nordisk Investigational Site
Waterbury, Connecticut, 06708
Novo Nordisk Investigational Site
West Palm Beach, Florida, 33401
Novo Nordisk Investigational Site
Wichita, Kansas, 67205

Other trials in United States

About this study

Official title: Effect of Inhaled Pre-Prandial Human Insulin Plus Metformin & Glimepiride Versus Rosiglitazone Plus Metformin & Glimepiride 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: rosiglitazone, inhaled human insulin, metformin, glimepiride
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.

rosiglitazoneDrug
Tablets, 4 mg once or twice daily.
inhaled human insulinDrug
Also called NN1998
Treat-to-target dose titration scheme, inhalation.
metforminDrug
Tablets, 2000 mg/day.
glimepirideDrug
Tablets, 8 mg/day.

Study groups in NCT00427154
Study group	Role	What they receive
A	Active comparator	Not described Receives: Drug: inhaled human insulin; Drug: metformin; Drug: glimepiride
B	Active comparator	Not described Receives: Drug: rosiglitazone; Drug: metformin; Drug: glimepiride

What is being measured

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

Change in HbA1c
Measured: After 26 weeks

Secondary outcomes (5)

Fasting plasma glucose
Measured: For the duration of the trial
Lipid profiles
Measured: For the duration of the trial
Hypoglycaemic episodes
Measured: For the duration of the trial
Glucose profiles
Measured: For the duration of the trial
Change in body weight
Measured: For the duration of the trial

Timeline

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

10 Jan 200711 Mar 2008

First posted26 Jan 2007 (estimated)
Study start10 Jan 2007
Primary completion11 Mar 2008
Study completion11 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: 227 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00427154
Sponsor's protocol ID: NN1998-1540
Status last verified: Sep 2018
First submitted: 25 Jan 2007
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

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)

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 Pre-Prandial Human Insulin Plus Metformin & Glimepiride Versus Rosiglitazone Plus Metformin & Glimepiride on HbA1c in Subjects With Type 2 Diabetes
ClinicalTrials.gov ID: NCT00427154
Acronym / sponsor ID: NN1998-1540
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: See termination reason in detailed description
Enrolment: 227 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 10 Jan 2007 (actual)
Primary completion: 11 Mar 2008 (actual)
Study completion: 11 Mar 2008 (actual)
First posted: 26 Jan 2007 (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	Active comparator	Drug: inhaled human insulin, Drug: metformin, Drug: glimepiride
B	Active comparator	Drug: rosiglitazone, Drug: metformin, Drug: glimepiride

Who may qualify

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

Key inclusion criteria (4 listed)

Type 2 diabetes
Currently treated with antidiabetes drugs (including Exenatide) for at least 2 months
HbA1c between 7.5 and 11.0% (both inclusive) on antidiabetes combination therapy
BMI less than or equal to 40 kg/m2

Key exclusion criteria (6 listed)

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

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
rosiglitazoneTablets, 4 mg once or twice daily.	Drug	B
inhaled human insulinAlso: NN1998Treat-to-target dose titration scheme, inhalation.	Drug	A
metforminTablets, 2000 mg/day.	Drug	A, B
glimepirideTablets, 8 mg/day.	Drug	A, B

Primary outcome

Change in HbA1c
Time frame: After 26 weeks

5 secondary outcomes

Fasting plasma glucose
Time frame: For the duration of the trial
Lipid profiles
Time frame: For the duration of the trial
Hypoglycaemic episodes
Time frame: For the duration of the trial
Glucose profiles
Time frame: For the duration of the trial
Change in body weight
Time frame: For the duration of the trial

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

103 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 rosiglitazone, inhaled human insulin and metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 103 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 4 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 103 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?

Change in HbA1c (time frame: After 26 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 NCT00427154.

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.