DiabetesPhase 3NCT00725036
Long Term Safety Trial to Compare Insulin Treatment With Preprandial Inhaled Human Insulin to s.c. Insulin Aspart Both Combined With NPH in Subjects With Type 1 Diabetes
A Phase 3 study testing inhaled human insulin, insulin aspart and insulin NPH in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 18 sites in Australia.
Trial summary
This trial is conducted in Oceania. The aim of this trial is to compare the safety of using pulmonary inhaled human insulin to s.c. insulin aspart both combined with NPH insulin in subjects with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1
- What is being tested?
- inhaled human insulin, insulin aspart and insulin NPH
- How many people
- 305 participants
- Where
- 18 sitesAustralia
- Study dates
- 2 Sep 2002to 14 Dec 2004
- 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 diabetes
- Current treatment with any insulin in any regimen
- Body mass index (BMI) below 38.0 kg/m2
- HbA1c below or equal to 13.0%
Who cannot join
- Total daily insulin dosage more than 100 IU/day
- Current acute or chronic pulmonary disease (excluding asthma)
- Recurrent major hypoglycaemia
- Proliferative retinopathy or maculopathy requiring acute treatment
- Smoker
- Chest X-ray with clinically significant abnormalities
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Australia18 sites
Novo Nordisk Investigational Site
Ashford, 5035
Novo Nordisk Investigational Site
Auckland
Novo Nordisk Investigational Site
Box Hill, 3128
Novo Nordisk Investigational Site
Broadmeadow, New South Wales, 2292
Novo Nordisk Investigational Site
Camperdown, New South Wales, 2050
Novo Nordisk Investigational Site
Christchurch
Novo Nordisk Investigational Site
Clayton, 3168
Novo Nordisk Investigational Site
Fremantle, Western Australia, 6160
Novo Nordisk Investigational Site
Garran, 2605
Novo Nordisk Investigational Site
Heidelberg, 3085
Novo Nordisk Investigational Site
Keswick, South Australia, 5035
Novo Nordisk Investigational Site
Parkville, 3050
Novo Nordisk Investigational Site
Perth, 6000
Novo Nordisk Investigational Site
Randwick, 2031
Novo Nordisk Investigational Site
St Leonards, New South Wales, 2065
Novo Nordisk Investigational Site
Stones Corner, 4120
Novo Nordisk Investigational Site
Wollongong, New South Wales, 2500
Novo Nordisk Investigational Site
Woolloongabba, Queensland, 4102
About this study
Official title: A 24-month Multicentre, Open-label, Randomised, Parallel Group, Long Term Safety Trial Comparing Intensive Treatment of Pulmonary Inhaled Human Insulin With Insulin Aspart Administered s.c., Both in Combination With NPH, in Subjects With Type 1 Diabetes
This trial is conducted in Oceania.
The aim of this trial is to compare the safety of using pulmonary inhaled human insulin to s.c. insulin aspart both combined with NPH insulin in subjects with type 1 diabetes.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Being tested
- inhaled human insulin, insulin aspart, insulin NPH
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhaled human insulinDrug
insulin aspartDrug
insulin NPHDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term pulmonary safety profiles
Measured: during treatment
Secondary outcomes (6)
Glycaemic control as measured by HbA1c
Incidence of hypoglycaemic episodes
Long-term safety profiles (laboratory, ECG, insulin antibodies)
Physical examination and body weight and vital signs
Adverse events
Treatment satisfaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study start2 Sep 2002
- Primary completion14 Dec 2004
- Study completion14 Dec 2004
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
- 305 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
- NCT00725036
- Sponsor's protocol ID
- NN1998-1496
- Status last verified
- Feb 2017
- First submitted
- 29 Jul 2008
- 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
- A 24-month Multicentre, Open-label, Randomised, Parallel Group, Long Term Safety Trial Comparing Intensive Treatment of Pulmonary Inhaled Human Insulin With Insulin Aspart Administered s.c., Both in Combination With NPH, in Subjects With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT00725036
- Acronym / sponsor ID
- NN1998-1496
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2002 (actual)
- Primary completion
- 14 Dec 2004 (actual)
- Study completion
- 14 Dec 2004 (actual)
- First posted
- 30 Jul 2008 (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 Oceania.
The aim of this trial is to compare the safety of using pulmonary inhaled human insulin to s.c. insulin aspart both combined with NPH insulin in subjects with type 1 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
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 1 diabetes
- Current treatment with any insulin in any regimen
- Body mass index (BMI) below 38.0 kg/m2
- HbA1c below or equal to 13.0%
Key exclusion criteria (6 listed)
- Total daily insulin dosage more than 100 IU/day
- Current acute or chronic pulmonary disease (excluding asthma)
- Recurrent major hypoglycaemia
- Proliferative retinopathy or maculopathy requiring acute treatment
- Smoker
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 insulin | Drug | – |
| insulin aspart | Drug | – |
| insulin NPH | Drug | – |
Primary outcome
Long term pulmonary safety profiles
Time frame: during treatment
6 secondary outcomes
Glycaemic control as measured by HbA1c
Incidence of hypoglycaemic episodes
Long-term safety profiles (laboratory, ECG, insulin antibodies)
Physical examination and body weight and vital signs
Adverse events
Treatment satisfaction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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
18 sites in 1 country: 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 aspart and insulin NPH in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 18 sites in Australia.
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: finished, 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 18 sites in Australia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Long term pulmonary safety profiles (time frame: during 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.