DiabetesPhase 3iINHALE 8NCT00472953
Safety of Inhaled Human Insulin in Subjects With Diabetes Mellitus and Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing inhaled human insulin and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 27 sites in 7 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- inhaled human insulin and insulin aspart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 27 sitesin 7 countries
- Study dates
- 15 May 2007to 5 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Recurrent severe hypoglycaemia
- Current smoking or smoking within the last 6 months
- Other pulmonary disease including asthma
- Proliferative retinopathy or maculopathy requiring acute treatment
Trial locations and contacts
27 sites in 7 countries.
27 sites in 7 countries
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
Turkey (Türkiye)6 sites
Novo Nordisk Investigational Site
Erzurum, 25240
Novo Nordisk Investigational Site
Gaziantep, 27070
Novo Nordisk Investigational Site
Istanbul, 34400
Novo Nordisk Investigational Site
Istanbul, 34722
Novo Nordisk Investigational Site
Istanbul, 34890
Novo Nordisk Investigational Site
Kocaeli, 41380
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
Argentina3 sites
Novo Nordisk Investigational Site
Buenos Aires, B1636DSU
Novo Nordisk Investigational Site
Buenos Aires, C1425AGC
Novo Nordisk Investigational Site
Ciudad de Buenos Aires, 1280
Taiwan3 sites
Novo Nordisk Investigational Site
Changhua, 500
Novo Nordisk Investigational Site
Chiayi City, 600
Novo Nordisk Investigational Site
Taipei, 231
Romania2 sites
Novo Nordisk Investigational Site
Bucharest, 020475
Novo Nordisk Investigational Site
Bucharest, 020992
Thailand2 sites
Novo Nordisk Investigational Site
Bangkok, 10330
Novo Nordisk Investigational Site
Bangkok, 10700
About this study
Official title: Inhaled Pre-prandial Human Insulin Versus Subcutaneous Injected Insulin Aspart in Subjects With Diabetes and Chronic Obstructive Pulmonary Disease: A 52-week Open Label, Multicentre, Randomized, Parallel Trial to Investigate Long-term Safety
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).
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, Chronic Obstructive Pulmonary Disease
- Being tested
- inhaled human insulin, insulin aspart
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Pulmonary Disease, Chronic Obstructive
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, pre-prandial, inhalation.
insulin aspartDrug
Treat-to-target dose titration scheme, pre-prandial, injection s.c.
| 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.
To evaluate pulmonary safety comparing inhaled insulin to subcutaneous injections
Measured: After one year
Secondary outcomes (3)
Patient Reported Outcomes
Measured: After one year
Diabetes control measured by change in HbA1c from baseline
Measured: After one year
Preprandial Insulin Doses
Measured: After one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2007 (estimated)
- Study start15 May 2007
- Primary completion5 Mar 2008
- Study completion5 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
- 38 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
- NCT00472953
- Sponsor's protocol ID
- NN1998-1617
- Other IDs
- 2006-004731-29
- Acronym
- iINHALE 8
- Status last verified
- Feb 2017
- First submitted
- 11 May 2007
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Pre-prandial Human Insulin Versus Subcutaneous Injected Insulin Aspart in Subjects With Diabetes and Chronic Obstructive Pulmonary Disease: A 52-week Open Label, Multicentre, Randomized, Parallel Trial to Investigate Long-term Safety
- ClinicalTrials.gov ID
- NCT00472953
- Acronym / sponsor ID
- iINHALE 8 / NN1998-1617
- Conditions
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Chronic Obstructive Pulmonary Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 15 May 2007 (actual)
- Primary completion
- 5 Mar 2008 (actual)
- Study completion
- 5 Mar 2008 (actual)
- First posted
- 14 May 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 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
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
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Recurrent severe hypoglycaemia
- Current smoking or smoking within the last 6 months
- Other pulmonary disease including asthma
- Proliferative retinopathy or maculopathy requiring acute treatment
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, pre-prandial, inhalation. | Drug | A |
| insulin aspartTreat-to-target dose titration scheme, pre-prandial, injection s.c. | Drug | B |
Primary outcome
To evaluate pulmonary safety comparing inhaled insulin to subcutaneous injections
Time frame: After one year
3 secondary outcomes
Patient Reported Outcomes
Time frame: After one year
Diabetes control measured by change in HbA1c from baseline
Time frame: After one year
Preprandial Insulin Doses
Time frame: After one year
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 1 Mar 2017.
- 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
27 sites in 7 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 and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 27 sites in 7 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 4 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 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in India, Turkey (Türkiye), Slovakia, Argentina, Taiwan and 2 more countries. 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?
To evaluate pulmonary safety comparing inhaled insulin to subcutaneous injections (time frame: After one year). 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 1 Mar 2017.