DiabetesPhase 3iINHALE 9NCT00523042
Safety of Inhaled Preprandial Human Insulin in Subjects With Diabetes and Asthma
A Phase 3 study testing insulin aspart and inhaled human insulin in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 32 sites in 6 countries.
Trial summary
This trial is conducted in Europe, Asia, Oceania and the United States of America (USA). This is a one-year clinical trial to compare the safety of inhaled preprandial human insulin to subcutaneous insulin aspart in subjects with type 1 or 2 diabetes and asthma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- insulin aspart and inhaled human insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 32 sitesin 6 countries
- Study dates
- 30 Aug 2007to 28 Feb 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 or type 2 diabetes
- Treatment with insulin and/or oral anti-diabetic drugs
- Asthma for at least 6 months
- Positive airway reversibility/bronchoprovocation test or documented positive test in the last 3 years
- HbA1C less than or equal to 11.0 %
- Body Mass Index (BMI) less than or equal to 40.0 kg/m2
Who cannot join
- Current smoking or smoking within the last 6 months
- Other current acute or chronic pulmonary disease excluding asthma
- Recurrent severe hypoglycaemia
- Proliferative retinopathy or maculopathy
Trial locations and contacts
32 sites in 6 countries.
32 sites in 6 countries
United States9 sites
Novo Nordisk Investigational Site
Columbus, Ohio, 43210
Novo Nordisk Investigational Site
Fresno, California, 93720
Novo Nordisk Investigational Site
Houston, Texas, 77030
Novo Nordisk Investigational Site
Kansas City, Missouri, 64108
Novo Nordisk Investigational Site
New Orleans, Louisiana, 70112
Novo Nordisk Investigational Site
Ogden, Utah, 84403
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19107
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, 15213
Novo Nordisk Investigational Site
Spokane, Washington, 99208
Australia8 sites
Novo Nordisk Investigational Site
Auchenflower, 4066
Novo Nordisk Investigational Site
Box Hill, Victoria, 3128
Novo Nordisk Investigational Site
Broadmeadow, New South Wales, 2292
Novo Nordisk Investigational Site
Camperdown, New South Wales, 2050
Novo Nordisk Investigational Site
East Ringwood, Victoria, 3135
Novo Nordisk Investigational Site
Keswick, South Australia, 5035
Novo Nordisk Investigational Site
Kippa-Ring, 4021
Novo Nordisk Investigational Site
Parkville, Victoria, 3052
India6 sites
Novo Nordisk Investigational Site
Chandigarh, Punjab, 160012
Novo Nordisk Investigational Site
Hyderabad, 600034
Novo Nordisk Investigational Site
Kolkata, West Bengal, 700020
Novo Nordisk Investigational Site
Mumbai, 400 067
Novo Nordisk Investigational Site
Pune, 411011
Novo Nordisk Investigational Site
Vellore, Tamil Nadu, 632004
Slovakia5 sites
Novo Nordisk Investigational Site
Košice, 04190
Novo Nordisk Investigational Site
Ľubochňa, 03491
Novo Nordisk Investigational Site
Moldava nad Bodvou, 045 01
Novo Nordisk Investigational Site
Žilina, 01001
Novo Nordisk Investigational Site
Žilina, 01207
Malaysia3 sites
Novo Nordisk Investigational Site
Cheras, 56000
Novo Nordisk Investigational Site
Kota Bharu, Kelantan, 16150
Novo Nordisk Investigational Site
Pulau Pinang, 10990
Serbia and Montenegro1 site
Novo Nordisk Investigational Site
Belgrade, 11000
About this study
Official title: Inhaled Preprandial Human Insulin With the AERx® iMS Versus Subcutaneous Injected Insulin Aspart in Subjects With Diabetes and Asthma: A 52-week, Open-label, Multinational, Randomised, Parallel Trial to Investigate Long-term Safety
This trial is conducted in Europe, Asia, Oceania and the United States of America (USA).
This is a one-year clinical trial to compare the safety of inhaled preprandial human insulin to subcutaneous insulin aspart in subjects with type 1 or 2 diabetes and asthma.
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, Diabetes Mellitus, Type 2, Asthma
- Being tested
- insulin aspart, inhaled human insulin
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin aspartDrug
Also called NovoRapid®, NovoLog®
Treat-to-target dose titration scheme, injection s.c.
inhaled human insulinDrug
Treat-to-target dose titration scheme, inhalation.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: inhaled human insulin |
| B | Active comparator | Not described Receives: Drug: insulin aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in lung function, chest X-rays, or asthma exacerbation frequency
Measured: after 52 weeks of treatment
Secondary outcomes (3)
Diabetes control measured by change in HbA1c
Measured: from baseline to end of treatment
Laboratory assessments (biochemistry, insulin antibodies, blood count)
Measured: from baseline to end of treatment
Preprandial insulin doses
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.
- First posted30 Aug 2007 (estimated)
- Study start30 Aug 2007
- Primary completion28 Feb 2008
- Study completion28 Feb 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523042
- Sponsor's protocol ID
- NN1998-1616
- Acronym
- iINHALE 9
- Status last verified
- Sep 2018
- First submitted
- 29 Aug 2007
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
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 Preprandial Human Insulin With the AERx® iMS Versus Subcutaneous Injected Insulin Aspart in Subjects With Diabetes and Asthma: A 52-week, Open-label, Multinational, Randomised, Parallel Trial to Investigate Long-term Safety
- ClinicalTrials.gov ID
- NCT00523042
- Acronym / sponsor ID
- iINHALE 9 / NN1998-1616
- Conditions
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2007 (actual)
- Primary completion
- 28 Feb 2008 (actual)
- Study completion
- 28 Feb 2008 (actual)
- First posted
- 30 Aug 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.
This trial is conducted in Europe, Asia, Oceania and the United States of America (USA).
This is a one-year clinical trial to compare the safety of inhaled preprandial human insulin to subcutaneous insulin aspart in subjects with type 1 or 2 diabetes and asthma.
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.
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 |
| B | Active comparator | 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 (6 listed)
- Type 1 or type 2 diabetes
- Treatment with insulin and/or oral anti-diabetic drugs
- Asthma for at least 6 months
- Positive airway reversibility/bronchoprovocation test or documented positive test in the last 3 years
- HbA1C less than or equal to 11.0 %
Key exclusion criteria (4 listed)
- Current smoking or smoking within the last 6 months
- Other current acute or chronic pulmonary disease excluding asthma
- Recurrent severe hypoglycaemia
- Proliferative retinopathy or maculopathy
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 |
|---|---|---|
| insulin aspartAlso: NovoRapid®, NovoLog®Treat-to-target dose titration scheme, injection s.c. | Drug | B |
| inhaled human insulinTreat-to-target dose titration scheme, inhalation. | Drug | A |
Primary outcome
Changes in lung function, chest X-rays, or asthma exacerbation frequency
Time frame: after 52 weeks of treatment
3 secondary outcomes
Diabetes control measured by change in HbA1c
Time frame: from baseline to end of treatment
Laboratory assessments (biochemistry, insulin antibodies, blood count)
Time frame: from baseline to end of treatment
Preprandial insulin doses
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.
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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
32 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing insulin aspart and inhaled human insulin in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 32 sites in 6 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 6 inclusion and 4 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 32 sites in United States, Australia, India, Slovakia, Malaysia and 1 more country. 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?
Changes in lung function, chest X-rays, or asthma exacerbation frequency (time frame: after 52 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.