DiabetesPhase 3iINHALE 7NCT00469586
Efficacy and Safety of Inhaled Insulin Compared to Metformin and Glimepiride in Type 2 Diabetes
A Phase 3 study testing inhaled human insulin, metformin and glimepiride in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 59 sites in 11 countries.
Trial summary
This trial is conducted in Europe, Asia, North America and South America. The aim of this research trial is to compare the efficacy of inhaled insulin to glimepiride and metformin combination therapy in treatment of subjects with type 2 diabetes and to verify the safety of use (hypoglycaemia, pulmonary function, body… 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?
- inhaled human insulin, metformin and glimepiride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 59 sitesin 11 countries
- Study dates
- 26 Apr 2007to 24 Apr 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
- Treated with OADs for more than or equal to 3 months
- HbA1c greater than or equal to 8.0% and less than or equal to 11.0%
- Body Mass Index (BMI) less than or equal to 40.0 kg/m2
Who cannot join
- Recurrent major hypoglycaemia
- Current smoking or smoking within the last 6 months
- Impaired hepatic or renal function
- Cardiac problems
- Uncontrolled hypertension
- Proliferative retinopathy or maculopathy
Trial locations and contacts
59 sites in 11 countries.
59 sites in 11 countries
Canada11 sites
Novo Nordisk Investigational Site
Edmonton, Alberta, T5J 3N4
Novo Nordisk Investigational Site
Halifax, Nova Scotia, B3H 2Y9
Novo Nordisk Investigational Site
Hamilton, Ontario, L8L 2X2
Novo Nordisk Investigational Site
Laval, Quebec, H7T 2P5
Novo Nordisk Investigational Site
Mississauga, L5M 2V8
Novo Nordisk Investigational Site
Oshawa, L1J 2K1
Novo Nordisk Investigational Site
Saskatoon, S7N 0W8
Novo Nordisk Investigational Site
Sherbrooke, Quebec, J1H 5N4
Novo Nordisk Investigational Site
Smiths Falls, Ontario, K7A 4W8
Novo Nordisk Investigational Site
Trois-Rivières, G8T 7A1
Novo Nordisk Investigational Site
Winnipeg, Manitoba, R3E 3P4
Poland8 sites
Novo Nordisk Investigational Site
Gdansk, 80-858
Novo Nordisk Investigational Site
Lodz, 90-030
Novo Nordisk Investigational Site
Lublin, 20-044
Novo Nordisk Investigational Site
Lublin, 20-538
Novo Nordisk Investigational Site
Mazowieckie, 09-400
Novo Nordisk Investigational Site
Rawa Mazowiecka, 96-200
Novo Nordisk Investigational Site
Warsaw, 02-097
Novo Nordisk Investigational Site
Zabrze, 41-800
Belgium6 sites
Novo Nordisk Investigational Site
Arlon, 6700
Novo Nordisk Investigational Site
Bonheiden, 2820
Novo Nordisk Investigational Site
Borsbeek, 2150
Novo Nordisk Investigational Site
Ghent, 9000
Novo Nordisk Investigational Site
Huy, 4500
Novo Nordisk Investigational Site
Leuven, 3000
France6 sites
Novo Nordisk Investigational Site
Corbeil-Essonnes, 91106
Novo Nordisk Investigational Site
Nantes, 44093
Novo Nordisk Investigational Site
Narbonne, 11108
Novo Nordisk Investigational Site
Nevers, 58033
Novo Nordisk Investigational Site
Paris, 75877
Novo Nordisk Investigational Site
Roubaix, 59100
Austria5 sites
Novo Nordisk Investigational Site
Ebreichsdorf, 2483
Novo Nordisk Investigational Site
Kittsee, A 2421
Novo Nordisk Investigational Site
Salzburg, 5020
Novo Nordisk Investigational Site
Vienna, 1130
Novo Nordisk Investigational Site
Vienna, A 1160
India5 sites
Novo Nordisk Investigational Site
Bangalore, 560041
Novo Nordisk Investigational Site
Coimbatore, 641002
Novo Nordisk Investigational Site
Hyderabad, 600034
Novo Nordisk Investigational Site
Indore, Madhya Pradesh, 452010
Novo Nordisk Investigational Site
Thriruvananthapuram, 695 032
Mexico5 sites
Novo Nordisk Investigational Site
Guadalajara, 44600
Novo Nordisk Investigational Site
Mexico City, México, D.F., 14000
Novo Nordisk Investigational Site
Mexico City, 03100
Novo Nordisk Investigational Site
Mexico City, 11650
Novo Nordisk Investigational Site
Monterrey, Nuevo León, 64460
Argentina4 sites
Novo Nordisk Investigational Site
Buenos Aires, B1636DSU
Novo Nordisk Investigational Site
Buenos Aires, C1425AGC
Novo Nordisk Investigational Site
Mar del Plata, B7600FZN
Novo Nordisk Investigational Site
Mendoza, 5500
Turkey (Türkiye)4 sites
Novo Nordisk Investigational Site
Istanbul, 34093
Novo Nordisk Investigational Site
Istanbul, 34371
Novo Nordisk Investigational Site
Istanbul, 34718
Novo Nordisk Investigational Site
Konya, 42001
Israel3 sites
Novo Nordisk Investigational Site
Beersheba, 84101
Novo Nordisk Investigational Site
Holon, 58100
Novo Nordisk Investigational Site
Jerusalem, 91120
Bulgaria2 sites
Novo Nordisk Investigational Site
Sofia, 1431
Novo Nordisk Investigational Site
Sofia, 1606
About this study
Official title: Efficacy and Safety of Inhaled Prandial Insulin Compared to Metformin Plus Glimepiride in Type 2 Diabetes
This trial is conducted in Europe, Asia, North America and South America. The aim of this research trial is to compare the efficacy of inhaled insulin to glimepiride and metformin combination therapy in treatment of subjects with type 2 diabetes and to verify the safety of use (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).
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, 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.
inhaled human insulinDrug
Also called NN1998
Treat-to-target dose titration scheme, pre-prandial, inhalation.
metforminDrug
Tablets, 2000 mg/day.
glimepirideDrug
Tablets, 4 mg/day.
inhaled human insulinDrug
Also called NN1998
Treat-to-target dose titration scheme, post-prandial, inhalation.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: inhaled human insulin |
| B | Experimental | Not described Receives: Drug: inhaled human insulin |
| C | Active comparator | Not described Receives: Drug: metformin; Drug: glimepiride |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c change from baseline
Measured: After 18 weeks of treatment
Secondary outcomes (5)
Adverse events
Measured: For the duration of the trial
Body weight
Measured: after 18 weeks of treatment
Lung function
Measured: after 18 weeks of treatment
Blood glucose
Measured: after 18 weeks of treatment
Hypoglycaemia
Measured: after 18 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 posted4 May 2007 (estimated)
- Study start26 Apr 2007
- Primary completion24 Apr 2008
- Study completion24 Apr 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
- 174 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
- NCT00469586
- Sponsor's protocol ID
- NN1998-1787
- Other IDs
- 2006-004623-12
- Acronym
- iINHALE 7
- Status last verified
- Feb 2017
- First submitted
- 3 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
- Efficacy and Safety of Inhaled Prandial Insulin Compared to Metformin Plus Glimepiride in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00469586
- Acronym / sponsor ID
- iINHALE 7 / NN1998-1787
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2007 (actual)
- Primary completion
- 24 Apr 2008 (actual)
- Study completion
- 24 Apr 2008 (actual)
- First posted
- 4 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, North America and South America. The aim of this research trial is to compare the efficacy of inhaled insulin to glimepiride and metformin combination therapy in treatment of subjects with type 2 diabetes and to verify the safety of use (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).
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 |
| B | Experimental | Drug: inhaled human insulin |
| C | Active comparator | 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
- Treated with OADs for more than or equal to 3 months
- HbA1c greater than or equal to 8.0% and less than or equal to 11.0%
- Body Mass Index (BMI) less than or equal to 40.0 kg/m2
Key exclusion criteria (6 listed)
- Recurrent major hypoglycaemia
- Current smoking or smoking within the last 6 months
- Impaired hepatic or renal function
- Cardiac problems
- Uncontrolled hypertension
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 insulinAlso: NN1998Treat-to-target dose titration scheme, pre-prandial, inhalation. | Drug | A |
| metforminTablets, 2000 mg/day. | Drug | C |
| glimepirideTablets, 4 mg/day. | Drug | C |
| inhaled human insulinAlso: NN1998Treat-to-target dose titration scheme, post-prandial, inhalation. | Drug | B |
Primary outcome
HbA1c change from baseline
Time frame: After 18 weeks of treatment
5 secondary outcomes
Adverse events
Time frame: For the duration of the trial
Body weight
Time frame: after 18 weeks of treatment
Lung function
Time frame: after 18 weeks of treatment
Blood glucose
Time frame: after 18 weeks of treatment
Hypoglycaemia
Time frame: after 18 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
59 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, metformin and glimepiride in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 59 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 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 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 59 sites in Canada, Poland, Belgium, France, Austria 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?
HbA1c change from baseline (time frame: After 18 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 1 Mar 2017.