DiabetesPhase 3NCT00343980
Safety and Efficacy of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes
A Phase 3 study testing rosiglitazone, inhaled human insulin and glimepiride in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 26 sites in 7 countries.
Trial summary
This trial is conducted in Asia, Europe and Oceania. The aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to glimepiride compared to adding rosiglitazone to glimepiride for the treatment of type 2 diabetes and to verify its safety (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?
- rosiglitazone, inhaled human insulin and glimepiride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 363 participants
- Where
- 26 sitesin 7 countries
- Study dates
- 10 Oct 2006to 10 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
- Treated with OAD(s) for more than or equal to 2 months
- Body mass index (BMI) less than or equal to 40.0 kg/m2
- HbA1c greater than or equal to 8.0 % and less than or equal to 11.0 % for subjects in OAD monotherapy
- HbA1c greater than or equal to 7.5 % and less than or equal to 10.0 % for subjects on OAD combination therapy
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
26 sites in 7 countries.
26 sites in 7 countries
Russia6 sites
Novo Nordisk Investigational Site
Moscow, 119034
Novo Nordisk Investigational Site
Moscow, 121356
Novo Nordisk Investigational Site
Moscow, 127486
Novo Nordisk Investigational Site
Moscow, 127644
Novo Nordisk Investigational Site
Saint Petersburg, 194354
Novo Nordisk Investigational Site
Saint Petersburg, 198013
India5 sites
Novo Nordisk Investigational Site
Bangalore, 560010
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, 600086
Novo Nordisk Investigational Site
Chennai, 600020
Novo Nordisk Investigational Site
Coimbatore, 641002
Novo Nordisk Investigational Site
Vellore, Tamil Nadu, 632004
Turkey (Türkiye)5 sites
Novo Nordisk Investigational Site
Bornova-IZMIR, 35100
Novo Nordisk Investigational Site
Bursa, 16059
Novo Nordisk Investigational Site
Istanbul, 34098
Novo Nordisk Investigational Site
Istanbul, 34390
Novo Nordisk Investigational Site
Istanbul, 34718
Australia4 sites
Novo Nordisk Investigational Site
Garran, 2605
Novo Nordisk Investigational Site
Kingswood, 2747
Novo Nordisk Investigational Site
St Leonards, New South Wales, 2065
Novo Nordisk Investigational Site
Wollongong, New South Wales, 2500
Philippines3 sites
Novo Nordisk Investigational Site
Cebu City, 6000
Novo Nordisk Investigational Site
Makati City, 1200
Novo Nordisk Investigational Site
Manila, 1000
Croatia2 sites
Novo Nordisk Investigational Site
Osijek, 31 000
Novo Nordisk Investigational Site
Zagreb, 10 000
About this study
Official title: Safety and Efficacy of Inhaled Pre-prandial Human Insulin Plus Glimepiride Versus Rosiglitazone Plus Glimepiride in Type 2 Diabetes
This trial is conducted in Asia, Europe and Oceania. The aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to glimepiride compared to adding rosiglitazone to glimepiride for the treatment of type 2 diabetes and to verify its safety (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
- rosiglitazone, inhaled human insulin, 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 a day.
inhaled human insulinDrug
Also called NN1998
Treat-to-target dose titration scheme, pre-prandial, inhalation.
glimepirideDrug
Tablets, 4 mg/day.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: inhaled human insulin; Drug: glimepiride |
| B | Active comparator | Not described Receives: Drug: rosiglitazone; Drug: glimepiride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment difference in HbA1c
Measured: After 26 weeks
Secondary outcomes (5)
Adverse events
Measured: For the duration of the trial
Body weight
Measured: during treatment
Lung function
Measured: after 26 weeks of treatment
Blood glucose
Measured: after 26 weeks of treatment
Hypoglycaemia
Measured: from 12-26 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 posted23 Jun 2006 (estimated)
- Study start10 Oct 2006
- Primary completion10 Mar 2008
- Study completion10 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
- 363 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
- NCT00343980
- Sponsor's protocol ID
- NN1998-1682
- Status last verified
- Feb 2017
- First submitted
- 22 Jun 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
- Safety and Efficacy of Inhaled Pre-prandial Human Insulin Plus Glimepiride Versus Rosiglitazone Plus Glimepiride in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00343980
- Acronym / sponsor ID
- NN1998-1682
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description
- Enrolment
- 363 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2006 (actual)
- Primary completion
- 10 Mar 2008 (actual)
- Study completion
- 10 Mar 2008 (actual)
- First posted
- 23 Jun 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 Oceania. The aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to glimepiride compared to adding rosiglitazone to glimepiride for the treatment of type 2 diabetes and to verify its safety (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
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: inhaled human insulin, Drug: glimepiride |
| B | Active comparator | Drug: rosiglitazone, Drug: glimepiride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetes
- Treated with OAD(s) for more than or equal to 2 months
- Body mass index (BMI) less than or equal to 40.0 kg/m2
- HbA1c greater than or equal to 8.0 % and less than or equal to 11.0 % for subjects in OAD monotherapy
- HbA1c greater than or equal to 7.5 % and less than or equal to 10.0 % for subjects on OAD combination therapy
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 |
|---|---|---|
| rosiglitazoneTablets, 4 mg once or twice a day. | Drug | B |
| inhaled human insulinAlso: NN1998Treat-to-target dose titration scheme, pre-prandial, inhalation. | Drug | A |
| glimepirideTablets, 4 mg/day. | Drug | A, B |
Primary outcome
Treatment difference in HbA1c
Time frame: After 26 weeks
5 secondary outcomes
Adverse events
Time frame: For the duration of the trial
Body weight
Time frame: during treatment
Lung function
Time frame: after 26 weeks of treatment
Blood glucose
Time frame: after 26 weeks of treatment
Hypoglycaemia
Time frame: from 12-26 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
26 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 rosiglitazone, inhaled human insulin and glimepiride in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 26 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 5 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 26 sites in Russia, India, Turkey (Türkiye), Australia, Philippines 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?
Treatment difference 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?
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.