DiabetesPhase 1NCT00419718
Effect of Exercise on the Absorption of Inhaled Human Insulin in Subjects With Type 1 Diabetes
A Phase 1 study testing inhaled human insulin in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Austria.
Trial summary
The trial is conducted in Europe. This clinical pharmacology trial investigates the effect of exercise on the pharmacokinetics and pharmacodynamics of inhaled insulin in subjects with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1
- What is being tested?
- inhaled human insulin
- How many people
- 23 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2005to Nov 2005
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes more than or equal to 12 months
- Baseline HbA1c less than or equal to 11%
- Body mass index (BMI) less than or equal to 29 kg/m2
- Normal lung volumes
- Treatment with intensified insulin therapy for at least 3 months
Who cannot join
- Any present or history of pulmonary disease
- Any findings from the cardiopulmonary exercise test compromising safety of moderate exercise
- Impaired hepatic or renal function
- Cardiac problems
- Uncontrolled hypertension
- Current proliferative retinopathy or maculopathy
Show all 9Show fewer
- Treatment with drugs, which may interfere with insulin action, glucose metabolism or recovery from hypoglycaemia (judged by investigator)
- Current smoking or smoking within the last 6 months
- Blood donation (more than 500 mL) within the last nine weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Exercise on the Pharmacokinetics and Pharmacodynamics of Inhaled Human Insulin in Subjects With Type 1 Diabetes
The trial is conducted in Europe. This clinical pharmacology trial investigates the effect of exercise on the pharmacokinetics and pharmacodynamics of inhaled insulin in subjects with type 1 diabetes.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Being tested
- inhaled human insulin
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma insulin profile in the interval
Measured: From 30-150 min after trial product administration
Secondary outcomes (4)
Area under the plasma insulin profile in the interval from 120-240 min after trial product administration
Area under the plasma insulin profile in the interval from 240-360 min after trial product administration
Area under the plasma insulin profile in the interval 0-600 min after trial product administration
Maximum plasma insulin concentration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2007 (estimated)
- Study startOct 2005
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 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
- NCT00419718
- Sponsor's protocol ID
- NN1998-1562
- Status last verified
- Jan 2017
- First submitted
- 8 Jan 2007
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Petersen AH, Kohler G, Korsatko S, Wutte A, Wonisch M, Jeppesen OK, Sparre T, Clauson P, Laursen T, Wollmer P, Pieber TR. The effect of exercise on the absorption of inhaled human insulin via the AERx insulin diabetes management system in people with type 1 diabetes. Diabetes Care. 2007 Oct;30(10):2571-6. doi: 10.2337/dc06-2589. Epub 2007 Jul 9.
PubMed 17620446
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise on the Pharmacokinetics and Pharmacodynamics of Inhaled Human Insulin in Subjects With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT00419718
- Acronym / sponsor ID
- NN1998-1562
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 9 Jan 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.
The trial is conducted in Europe. This clinical pharmacology trial investigates the effect of exercise on the pharmacokinetics and pharmacodynamics of inhaled insulin in subjects with type 1 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 1 diabetes more than or equal to 12 months
- Baseline HbA1c less than or equal to 11%
- Body mass index (BMI) less than or equal to 29 kg/m2
- Normal lung volumes
- Treatment with intensified insulin therapy for at least 3 months
Key exclusion criteria (9 listed)
- Any present or history of pulmonary disease
- Any findings from the cardiopulmonary exercise test compromising safety of moderate exercise
- 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 insulin | Drug | – |
Primary outcome
Area under the plasma insulin profile in the interval
Time frame: From 30-150 min after trial product administration
4 secondary outcomes
Area under the plasma insulin profile in the interval from 120-240 min after trial product administration
Area under the plasma insulin profile in the interval from 240-360 min after trial product administration
Area under the plasma insulin profile in the interval 0-600 min after trial product administration
Maximum plasma insulin concentration
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 24 Jan 2017.
- Results publication: PubMed 17620446Petersen AH, Kohler G, Korsatko S, Wutte A, Wonisch M, Jeppesen OK, Sparre T, Clauson P, Laursen T, Wollmer P, Pieber TR. The effect of exercise on the absorption of inhaled human insulin via the AERx insulin diabetes management system in people with type 1 diabetes. Diabetes Care. 2007 Oct;30(10):2571-6. doi: 10.2337/dc06-2589. Epub 2007 Jul 9.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing inhaled human insulin in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Austria.
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 9 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 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Area under the plasma insulin profile in the interval (time frame: From 30-150 min after trial product administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00419718, which also lists 1 linked publication.
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 24 Jan 2017.