DiabetesPhase 3NCT00331604
Safety and Efficacy of Inhaled Insulin in Type 2 Diabetes
A Phase 3 study testing inhaled human insulin, insulin detemir and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 73 sites in 11 countries.
Trial summary
This trial is conducted in Asia, Europe and South America. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function tests, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin detemir in… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- 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
- 618 participants
- Where
- 73 sitesin 11 countries
- Study dates
- 31 Aug 2006to 5 May 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- Currently treated with insulin
- Body mass index of (BMI) less than or equal to 40.0 kg/m2
- HbA1c less than or equal to 11.0%
Who cannot join
- Total daily insulin dosage less than or equal to 100 IU or U/day
- Current smoking or smoking within the last 6 months
- Cardiac problems
- Uncontrolled hypertension
- Current proliferative retinopathy or maculopathy
Trial locations and contacts
73 sites in 11 countries.
73 sites in 11 countries
Germany17 sites
Novo Nordisk Investigational Site
Bad Harzburg, 38667
Novo Nordisk Investigational Site
Bad Kreuznach, 55545
Novo Nordisk Investigational Site
Bad Lauterberg im Harz, 37431
Novo Nordisk Investigational Site
Dresden, 01219
Novo Nordisk Investigational Site
Dresden, 01307
Novo Nordisk Investigational Site
Friedrichsthal, 66299
Novo Nordisk Investigational Site
Hamburg, 21073
Novo Nordisk Investigational Site
Hamburg, 22607
Novo Nordisk Investigational Site
Herrenberg, 71083
Novo Nordisk Investigational Site
Hohenmölsen, 06679
Novo Nordisk Investigational Site
Neumünster, 24534
Novo Nordisk Investigational Site
Neuwied, 56564
Novo Nordisk Investigational Site
Saint Ingbert, 66386
Novo Nordisk Investigational Site
Schkeuditz, 04435
Novo Nordisk Investigational Site
Speyer, 67346
Novo Nordisk Investigational Site
Völklingen, 66333
Novo Nordisk Investigational Site
Warburg, 34414
United Kingdom12 sites
Novo Nordisk Investigational Site
Aberdeen, AB25 1LD
Novo Nordisk Investigational Site
Ayr, KA6 6DX
Novo Nordisk Investigational Site
Bristol, BS10 5NB
Novo Nordisk Investigational Site
Cosham, PO6 3LY
Novo Nordisk Investigational Site
Edgbaston, Birmingham, B15 2TH
Novo Nordisk Investigational Site
Edinburgh, EH16 4SA
Novo Nordisk Investigational Site
Livingstone, EH54 6PP
Novo Nordisk Investigational Site
Nottingham, NG7 2UH
Novo Nordisk Investigational Site
Plymouth, PL6 8BQ
Novo Nordisk Investigational Site
Salford, M6 8HD
Novo Nordisk Investigational Site
Sheffield, S5 7AU
Novo Nordisk Investigational Site
Wirral, Merseyside, CH63 4JY
Italy11 sites
Novo Nordisk Investigational Site
Bari, 70124
Novo Nordisk Investigational Site
Catania, 95122
Novo Nordisk Investigational Site
Catanzaro, 88100
Novo Nordisk Investigational Site
Milan, 20132
Novo Nordisk Investigational Site
Perugia, 06126
Novo Nordisk Investigational Site
Pescara, 65124
Novo Nordisk Investigational Site
Pisa, 56100
Novo Nordisk Investigational Site
Roma, 00133
Novo Nordisk Investigational Site
Roma, 00168
Novo Nordisk Investigational Site
San Giovanni Rotondo, 71013
Novo Nordisk Investigational Site
Verona, 37126
Spain9 sites
Novo Nordisk Investigational Site
Almería, 04001
Novo Nordisk Investigational Site
Cáceres, 10004
Novo Nordisk Investigational Site
Elche, 3203
Novo Nordisk Investigational Site
Granada, 18012
Novo Nordisk Investigational Site
Lugo, 27004
Novo Nordisk Investigational Site
Mostoles - Madrid -, 28935
Novo Nordisk Investigational Site
Seville, 41014
Novo Nordisk Investigational Site
Valladolid, 47011
Novo Nordisk Investigational Site
Xátiva, 46800
France8 sites
Novo Nordisk Investigational Site
Brest, 29200
Novo Nordisk Investigational Site
Grenoble, 38043
Novo Nordisk Investigational Site
La Rochelle, 17019
Novo Nordisk Investigational Site
Nanterre, 92014
Novo Nordisk Investigational Site
Narbonne, 11108
Novo Nordisk Investigational Site
Nevers, 58033
Novo Nordisk Investigational Site
Strasbourg, 67091
Novo Nordisk Investigational Site
Toulouse, 31054
Brazil4 sites
Novo Nordisk Investigational Site
Campinas, 13083-900
Novo Nordisk Investigational Site
Higienópolis, 01244-030
Novo Nordisk Investigational Site
Porto Alegre, 90035-170
Novo Nordisk Investigational Site
São Paulo, 04022-001
Denmark3 sites
Novo Nordisk Investigational Site
Århus C, 8000
Novo Nordisk Investigational Site
Hillerød, 3400
Novo Nordisk Investigational Site
Hvidovre, 2650
Israel3 sites
Novo Nordisk Investigational Site
Beersheba, 84101
Novo Nordisk Investigational Site
Holon, 58100
Novo Nordisk Investigational Site
Jerusalem, 91120
Taiwan3 sites
Novo Nordisk Investigational Site
Taichung, 407
Novo Nordisk Investigational Site
Taipei, 100
Novo Nordisk Investigational Site
Taipei, 114
Singapore2 sites
Novo Nordisk Investigational Site
Singapore, 119074
Novo Nordisk Investigational Site
Singapore, 159964
About this study
Official title: Inhaled Pre-prandial Human Insulin With the AERx® iDMS Versus s.c. Insulin Aspart in Type 2 Diabetes: A 104 Week, Open-label, Multicenter, Randomised, Trial Followed by a 12 Week Re-randomised Extension to Investigate Safety and Efficacy
This trial is conducted in Asia, Europe and South America. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function tests, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin detemir in 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
- inhaled human insulin, insulin detemir, insulin aspart
- 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.
inhaled human insulinDrug
Treat-to-target dose titration scheme, inhalation.
insulin detemirDrug
Also called NN304, Levemir
Injection s.c., 50% of daily dose.
insulin aspartDrug
Treat-to-target dose titration scheme, injection s.c.
insulin aspartDrug
Treat-to-target dose titration scheme, injection s.c. After 2 years.
| 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 |
| C | 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.
Treatment difference in HbA1c
Measured: After 52 weeks
Secondary outcomes (5)
Adverse events
Measured: For the duration of the trial
Blood glucose
Measured: After 52, 104 and 116 weeks of treatment
Body weight
Measured: During treatment
Lung function
Measured: After 52, 104 and 116 weeks of treatment
Hypoglycaemia
Measured: From 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2006 (estimated)
- Study start31 Aug 2006
- Primary completion5 May 2008
- Study completion5 May 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
- 618 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
- NCT00331604
- Sponsor's protocol ID
- NN1998-2161
- Other IDs
- 2005-005378-58, 2005
- Status last verified
- Feb 2017
- First submitted
- 24 May 2006
- 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 With the AERx® iDMS Versus s.c. Insulin Aspart in Type 2 Diabetes: A 104 Week, Open-label, Multicenter, Randomised, Trial Followed by a 12 Week Re-randomised Extension to Investigate Safety and Efficacy
- ClinicalTrials.gov ID
- NCT00331604
- Acronym / sponsor ID
- NN1998-2161
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description
- Enrolment
- 618 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2006 (actual)
- Primary completion
- 5 May 2008 (actual)
- Study completion
- 5 May 2008 (actual)
- First posted
- 31 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.
This trial is conducted in Asia, Europe and South America. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function tests, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin detemir in Type 2 Diabetes.
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
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: inhaled human insulin, Drug: insulin detemir |
| B | Active comparator | Drug: insulin detemir, Drug: insulin aspart |
| C | Active comparator | Drug: insulin detemir, Drug: insulin aspart |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes
- Currently treated with insulin
- Body mass index of (BMI) less than or equal to 40.0 kg/m2
- HbA1c less than or equal to 11.0%
Key exclusion criteria (5 listed)
- Total daily insulin dosage less than or equal to 100 IU or U/day
- Current smoking or smoking within the last 6 months
- Cardiac problems
- Uncontrolled hypertension
- Current 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 |
|---|---|---|
| inhaled human insulinTreat-to-target dose titration scheme, inhalation. | Drug | A |
| insulin detemirAlso: NN304, LevemirInjection s.c., 50% of daily dose. | Drug | A, B, C |
| insulin aspartTreat-to-target dose titration scheme, injection s.c. | Drug | B, C |
| insulin aspartTreat-to-target dose titration scheme, injection s.c. After 2 years. | Drug | C |
Primary outcome
Treatment difference in HbA1c
Time frame: After 52 weeks
5 secondary outcomes
Adverse events
Time frame: For the duration of the trial
Blood glucose
Time frame: After 52, 104 and 116 weeks of treatment
Body weight
Time frame: During treatment
Lung function
Time frame: After 52, 104 and 116 weeks of treatment
Hypoglycaemia
Time frame: From 12 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 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
73 sites in 11 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 2, run by Novo Nordisk A/S at 73 sites in 11 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 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 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 73 sites in Germany, United Kingdom, Italy, Spain, France and 6 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?
Treatment difference in 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?
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.