DiabetesPhase 2NCT00567775
Comparison of Human Insulin to Insulin Inhalation Solution in Children With Type 1 Diabetes
A Phase 2 study testing human insulin and inhaled human insulin in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Denmark.
Trial summary
This trial is conducted in Europe. The aim of this trial is to compare the pharmacokinetic profile of two different methods of insulin administration in children with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1
- What is being tested?
- human insulin and inhaled human insulin
- How many people
- 27 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Oct 2002to 20 Nov 2002
- Phase
- Phase 2
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Type 1 diabetes
- Treatment for at least 12 months
- HbA1c lesser or equal to 11.0%
- Body weight between 25 and 80 Kg
- Capable to use the device
Who cannot join
- Any diseases other than diabetes requiring prescriptive medication
- Known or suspected allergy to trial product or related products
- Active proliferative retinopathy as judged by the Investigator
- Recurrent severe hypoglycaemia as judged by the Investigator
- The receipt of any investigational drug within 4 weeks prior to this trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Pharmacokinetic Profiles of Human Soluble Insulin With Insulin Inhalation Solution in Paediatric Type 1 Diabetes Mellitus
This trial is conducted in Europe. The aim of this trial is to compare the pharmacokinetic profile of two different methods of insulin administration in children with type 1 diabetes.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Being tested
- human insulin, 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.
human insulinDrug
Also called Actrapid®, Novolin® R
inhaled human insulinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the serum insulin curve
Measured: from 0 to 5 hours post-dosing
Secondary outcomes (2)
Maximum serum insulin concentration
Measured: in the interval from 0 to 5 hours post-dosing
Time to maximum serum insulin concentration
Measured: in the interval from 0 to 5 hours post-dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study start21 Oct 2002
- Primary completion20 Nov 2002
- Study completion20 Nov 2002
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 27 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
- NCT00567775
- Sponsor's protocol ID
- NN1998-1274
- Status last verified
- Feb 2017
- First submitted
- 30 Nov 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
- Comparison of Pharmacokinetic Profiles of Human Soluble Insulin With Insulin Inhalation Solution in Paediatric Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00567775
- Acronym / sponsor ID
- NN1998-1274
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2002 (actual)
- Primary completion
- 20 Nov 2002 (actual)
- Study completion
- 20 Nov 2002 (actual)
- First posted
- 5 Dec 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. The aim of this trial is to compare the pharmacokinetic profile of two different methods of insulin administration in children with type 1 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Type 1 diabetes
- Treatment for at least 12 months
- HbA1c lesser or equal to 11.0%
- Body weight between 25 and 80 Kg
- Capable to use the device
Key exclusion criteria (5 listed)
- Any diseases other than diabetes requiring prescriptive medication
- Known or suspected allergy to trial product or related products
- Active proliferative retinopathy as judged by the Investigator
- Recurrent severe hypoglycaemia as judged by the Investigator
- The receipt of any investigational drug within 4 weeks prior to this trial
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 |
|---|---|---|
| human insulinAlso: Actrapid®, Novolin® R | Drug | – |
| inhaled human insulin | Drug | – |
Primary outcome
Area under the serum insulin curve
Time frame: from 0 to 5 hours post-dosing
2 secondary outcomes
Maximum serum insulin concentration
Time frame: in the interval from 0 to 5 hours post-dosing
Time to maximum serum insulin concentration
Time frame: in the interval from 0 to 5 hours post-dosing
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing human insulin and inhaled human insulin in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Denmark.
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 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: 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 1 site in Denmark. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 serum insulin curve (time frame: from 0 to 5 hours post-dosing). 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.